510(k) · Cleared
ClearedDePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · HRS Plate, Fixation, Bone
Cleared on Jun 30, 2017 as substantially equivalent to K000089 (Synthes (Usa), 2000) and 49 other predicates after a 487-day review. Its family tree reaches back 14 generations to 1996.
- Decided
- Jun 30, 2017
- Review
- 487 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 50
Its longest line of descent runs back 14 generations to K962616 (1996). 190 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 10 generations between
- 3 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 2 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 1 generation backK121601 Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma…Synthes USA · 2012
- This deviceK160553 DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017
Show all 14 generations
- Root · 14 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 13 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 12 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 11 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 10 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 9 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 8 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 7 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 6 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 5 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 4 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 3 generations backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- 2 generations backK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- 1 generation backK121601 Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma…Synthes USA · 2012
- This deviceK160553 DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −13 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −12 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −11 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −10 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −9 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −8 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −7 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −6 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −5 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −4 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −3 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| −2 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| −1 | K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal… | Synthes USA | 2012 | — |
| 0 (this device) | K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes… | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 4 | 0 |
| 1996 | 12 | 0 |
| 1997 | 2 | 0 |
| 1998 | 5 | 0 |
| 1999 | 6 | 0 |
| 2000 | 12 | 0 |
| 2001 | 12 | 0 |
| 2002 | 8 | 0 |
| 2003 | 12 | 0 |
| 2004 | 16 | 0 |
| 2005 | 13 | 0 |
| 2006 | 9 | 0 |
| 2007 | 7 | 0 |
| 2008 | 12 | 0 |
| 2009 | 13 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HRS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (50)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000089 | Synthes 4.0 and 5.0 MM Locking ScrewsSummary page 57…mm Locking Screws – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II; 888.3040 Product Code(s): HWC 1.3. Predicate Device K000089 DePuy Synthes 4.0 mm and 5.0 mm Locking Screws 1.4. Device Description The DePuy Synthes 4.0 mm and 5.0 mm Locking Screws ar… | 2000 |
| * | K000558 | Synthes (Usa) Wrist Fusion Plates (WFP)Summary page 59…n Name(s): Single/multiple component bone fixation appliances and accessories Regulatory Class: Class II; 888.3030 Product Code(s): HRS, LXT 1.3. Predicate Device K000558 DePuy Synthes Wrist Fusion Plate (WFP) 1.4. Device Description The DePuy Synthes Wrist Fusion Plate (WFP) feature a limited-… | 2000 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 61…ame(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Regulatory Class: Class II; 888.3030 Product Code(s): KTT, HRS 1.3. Predicate Device K000682 DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System 1.4. Device Description The DePuy Synthes Large Fragme… | 2000 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 63…ame(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Regulatory Class: Class II; 888.3030 Product Code(s): KTT, HRS 1.3. Predicate Device K000684 DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System 1.4. Device Description The DePuy Synthes Small Fragme… | 2000 |
| * | K001941 | Synthes Modular Foot SystemSummary page 65…odular Foot System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K001941 DePuy Synthes Modular Foot System 1.4. Device Description The DePuy Synthes Modular Foot System is a series of plates and sc… | 2000 |
| * | K010766 | Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T PlateSummary page 67…cation Name(s): Single/multiple component bone fixation appliances and accessories Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K010766 DePuy Synthes T-Plates 1.4. Device Description The DePuy Synthes Locking Compression Plate (LCP) System - T Plate is a buttr… | 2001 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 69…cation Name(s): Single/multiple component bone fixation appliances and accessories Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K011335 DePuy Synthes One-third Tubular Plate with Collar (OTPC) 1.4. Device Description The DePuy Synthes One-Third Tubular DCL Pla… | 2001 |
| * | K030310 | Synthes Stainless Steel Modular Hand SystemSummary page 71…r Hand System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HWC 1.3. Predicate Device K030310 DePuy Synthes Stainless Steel Modular Hand System 1.4. Device Description The DePuy Synthes Stainless Steel Modular Hand Sys… | 2003 |
| * | K031725 | Synthes TI-15 MO Locking Distal Radius Plating SystemSummary page 73…ion Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Regulatory Class: Class II; 888.3030 Product Code(s): KTT 1.3. Predicate Device K031725 DePuy Synthes Ti-15 Mo Locking Distal Radius Plating System 1.4. Device Description The DePuy Synthes Ti-15Mo Locking Distal… | 2003 |
| * | K032032 | Synthes (Usa) LCP Proximal Femur Hook PlatesSummary page 75…cation Name(s): Single/multiple component bone fixation appliances and accessories Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K032032 DePuy Synthes Hook Plate 1.4. Device Description The DePuy SynthesLCP Proximal Femur Hook Plates are contoured to match the… | 2003 |
| * | K033071 | Synthes (Usa) Cannulated Titanium Humeral Nail SystemSummary page 77…Humeral Nail System – MR Conditional Classification Name(s): Nail, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): JDS 1.3. Predicate Device K033071 DePuy Synthes Cannulated Titanium Humeral Nail System 1.4. Device Description The DePuy Synthes Titanium Cannulated Humeral… | 2003 |
| * | K040762 | Synthes (Usa) Tibial Nail System EXSummary page 79…bial Nail System Ex – MR Conditional Classification Name(s): Nail, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): JDS 1.3. Predicate Device K040762 DePuy Synthes Tibial Nail System Ex 1.4. Device Description The DePuy Synthes Tibial Nail System Ex is composed of cannulate… | 2004 |
| * | K041911 | Synthes (Usa) LCP Curved PlatesSummary page 81…cation Name(s): Single/multiple component bone fixation appliances and accessories Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K041911 DePuy Synthes LCP® Curved Plates 1.4. Device Description The DePuy Synthes LCP® Curved Plates have a slight curve to better… | 2004 |
| * | K042135 | Synthes (Usa) Elastic Intramedullary Nail (Ein) System (Line Extension)Summary page 83…Conditional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB 1.3. Predicate Device K042135 DePuy Synthes Elastic Intramedullary Nail (EIN) System 1.4. Device Description The DePuy Synthes EIN system consists of flex… | 2004 |
| * | K042355 | Synthes (Usa) LCP Wrist Fusion PlatesSummary page 85…rist Fusion Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K042355 DePuy Synthes LCP Wrist Fusion Plates 1.4. Device Description The DePuy Synthes LCP Wrist Fusion Plates are pre-contoured wi… | 2004 |
| * | K052483 | Synthes (Usa) Spherical WashersSummary page 87…cation Name(s): Single/multiple component bone fixation appliances and accessories Regulatory Class: Class II; 888.3030 Product Code(s): HTN 1.3. Predicate Device K052483 DePuy Synthes Washer 1.4. Device Description The DePuy Synthes Spherical Washers are round or oval in design with a slotted… | 2005 |
| * | K053105 | Synthes (Usa) Elastic Intramedullary Nail (Ein) End CapSummary page 89…Conditional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB 1.3. Predicate Device K053105 DePuy Synthes Elastic Intramedullary Nail (EIN) End Cap 1.4. Device Description The DePuy Synthes Elastic Intramedullary Nai… | 2005 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 91…ragment LCP System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K063049 DePuy Synthes Modular Mini Fragment LCP System 1.4. Device Description The DePuy Synthes Modular Mini Fragment LCP System in… | 2006 |
| * | K070946 | Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius PlatesSummary page 93…stal Radius Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K070946 DePuy Synthes LCP Diaphyseal-Metaphyseal (Dia-Meta) Volar Distal Radius Plates 1.4. Device Description The DePuy Synthes LCP… | 2007 |
| * | K071184 | Synthes (Usa) Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius SystemSummary page 95…stal Radius System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K071184 DePuy Synthes Variable Angle-Locking Compression Plate (VA-LCP) Distal Radius System 1.4. Device Description The DePuy Synth… | 2007 |
| * | K081452 | Synthes (Usa) Stainless Steel Elastic Intramedullary Nail SystemSummary page 97…Conditional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB 1.3. Predicate Device K081452 DePuy Synthes Stainless Steel Elastic Intramedullary Nail System 1.4. Device Description The DePuy Synthes Stainless Steel E… | 2008 |
| * | K082148 | Synthes (Usa) Elastic Intramedullary Nail (Ein) End Cap, Line ExtensionSummary page 99…Conditional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB 1.3. Predicate Device K082148 DePuy Synthes Elastic Intramedullary Nail (EIN) End Cap 1.4. Device Description The DePuy Synthes Elastic Intramedullary Nai… | 2008 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 101…cation Name(s): Single/multiple component bone fixation appliances and accessories Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K082807 DePuy Synthes Limited Contact - Dynamic Compression Plates (LC-DCP's) 1.4. Device Description The DePuy Synthes 3.5 mm and 4… | 2008 |
| * | K083694 | Synthes (Usa) 2.4 MM VA-LCP Two Column Volar Distal Radius PlatesSummary page 103…stal Radius Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K083694 DePuy Synthes 2.4 mm VA-LCP Two Column Volar Distal Radius Plates 1.4. Device Description The DePuy Synthes 2.4 mm Variable… | 2009 |
| * | K090047 | Synthes (Usa) 1.5MM Mini Fragment LCP SystemSummary page 105…ragment LCP System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K090047 DePuy Synthes 1.5 mm Mini Fragment LCP System 1.4. Device Description The DePuy Synthes 1.5 mm Mini Fragment LCP System cons… | 2009 |
| * | K091644 | Synthes (Usa) 2.4MM LCP Volar Column Distal Radius PlatesSummary page 107…Radius Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HWC 1.3. Predicate Device K091644 DePuy Synthes 2.4 mm LCP Volar Column Distal Radius Plates 1.4. Device Description The DePuy Synthes 2.4 mm LCP Volar Column… | 2009 |
| * | K092247 | Synthes Locking Hand PlatesSummary page 109…ocking Hand Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K092247 DePuy Synthes Locking Hand Plates 1.4. Device Description The DePuy Synthes Locking Hand plates consist of 2.0 mm LCP Distal… | 2009 |
| * | K092556 | Synthes (Usa) 2.4MM VA-LCP Two-Column Narrow Volar Distal RadiusSummary page 111…Distal Radius – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HWC 1.3. Predicate Device K092556 DePuy Synthes 2.4 mm VA-LCP Two-Column Narrow Volar Distal Radius 1.4. Device Description The DePuy Synthes 2.4 mm V A-LCP T… | 2009 |
| * | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSummary page 40…ew may also be used in fusion applications in adults and adolescents (12-21 years) when used with the Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the Synthes Ti Wrist Fusion Plate (K023879). The DePuy Synthes… | 2010 |
| * | K102694 | 2.4MM VA-LCP Dorsal Distal Radius PlatesSummary page 115…stal Radius Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K102694 DePuy Synthes 2.4 mm VA-LCP Dorsal Distal Radius Plates 1.4. Device Description The DePuy Synthes 2.4 mm Variable Angle LCP… | 2010 |
| * | K103002 | Synthes Multiloc Proximal Humeral Nailing SystemSummary page 118…Conditional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB 1.3. Predicate Device K103002 DePuy Synthes Multiloc Proximal Humeral Nailing System 1.4. Device Description The DePuy Synthes MultiLoc Proximal Humeral N… | 2011 |
| * | K103243 | 2.4MM VA-LCP Intercarpal Fusion SystemSummary page 120…Fusion System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HWC 1.3. Predicate Device K103243 DePuy Synthes 2.4 mm VA-LCP Intercarpal Fusion System 1.4. Device Description The DePuy Synthes 2.4 mm VA-LCP Intercarpal Fu… | 2011 |
| * | K110125 | 2.4 MM VA-LCP Volar Rim Distal Radius SystemSummary page 122…Radius System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HWC 1.3. Predicate Device K110125 DePuy Synthes 2.4 mm VA-LCP Volar Rim Distal Radius System 1.4. Device Description The DePuy Synthes 2.4 mm Variable Angle L… | 2011 |
| * | K111230 | Synthes 3.5MM Low Profile Cortical ScrewSummary page 124…ile Cortical Screw – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II; 888.3040 Product Code(s): HWC 1.3. Predicate Device K111230 DePuy Synthes 3.5mm Low Profile Cortical Screw 1.4. Device Description The DePuy Synthes 3.5 mm Low Profile Cortical Screws… | 2011 |
| * | K112085 | Synthes LCP Pediatric Plate SystemsSummary page 126…Plate Systems – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HWC 1.3. Predicate Device K112085 DePuy Synthes LCP Pediatric Plate Systems 1.4. Device Description The DePuy Synthes system is a collection of plates used to… | 2011 |
| * | K112583 | Synthes Cortical ScrewsSummary page 128…es Cortical Screws – MR Conditional Classification Name(s): Screw, Fixation, Bone Regulatory Class: Class II; 888.3040 Product Code(s): HWC 1.3. Predicate Device K112583 DePuy Synthes Cortical Screws 1.4. Device Description The DePuy Synthes Cortical Screws have self-tapping features, stardriv… | 2011 |
| * | K113364 | 2.7MM LCP Ulna Osteotomy SystemSummary page 130…eotomy System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HWC 1.3. Predicate Device K113364 DePuy Synthes 2.7 mm LCP Ulna Osteotomy System 1.4. Device Description The DePuy Synthes 2.7 mm LCP Ulna Osteotomy System co… | 2012 |
| * | K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSummary page 132…Plate System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HWC 1.3. Predicate Device K120689 DePuy Synthes 3.5 mm VA-LCP Proximal Tibia Plate System 1.4. Device Description The DePuy Synthes 3.5 mm VA-LCP Proximal Tib… | 2012 |
| * | K120807 | Synthes Multiloc Humeral Nailing SystemSummary page 134…Conditional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB 1.3. Predicate Device K120807 DePuy Synthes Multiloc Humeral Nailing System 1.4. Device Description The DePuy Synthes MultiLoc Humeral Nailing System cons… | 2012 |
| * | K120854 | Synthes VA LCP Ankle Trauma SystemSummary page 136…Trauma System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HWC 1.3. Predicate Device K120854 DePuy Synthes VA LCP Ankle Trauma System 1.4. Device Description The DePuy Synthes Variable Angle LCP Ankle Trauma System co… | 2012 |
| * | K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia PlateSummary page 138…l Tibia Plate – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HWC 1.3. Predicate Device K121601 DePuy Synthes 2.7/3.5 mm Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate 1.4. Device Description The… | 2012 |
| * | K131186 | Synthes 2.7MM and 3.5MM Variable Angle LCP Midfoot/Hindfoot SystemSummary page 140…ndfoot System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HWC 1.3. Predicate Device K131186 DePuy Synthes 2.7 mm and 3.5 mm Variable Angle LCP Midfoot/Hindfoot System 1.4. Device Description The DePuy Synthes 2.7 mm… | 2013 |
| * | K161616 | DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws… Cleared while this submission was under review Summary page 142…assification Name(s): Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II; 888.3040 Product Code(s): HWC, HRS, HTN 1.3. Predicate Device K161616 DePuy Synthes Cortex Screws (4.0 mm and 4.5 mm), DePuy Synthes Cannulated Screws (2.4 mm, 3.5 mm, 4.0 mm, 4.5 mm, 6.5 mm, 7.0 mm,… | 2017 |
| * | K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle… Cleared while this submission was under review Summary page 146…cation Name(s): Single/multiple component bone fixation appliances and accessories Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K162124 DePuy Synthes Condylar Buttress Plates 1.4. Device Description The DePuy Synthes 4.5 mm VA LCP Curved Condylar Plate System… | 2017 |
| * | K914546 | Angled Blade PlateSummary page 148…Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Regulatory Class: Class II; 888.3030 Product Code(s): KTW, HRS 1.3. Predicate Device K914546 DePuy Synthes Angled Blade Plate 1.4. Device Description The DePuy Synthes Angled Blade Plates are manufactured from 316L st… | 1991 |
| * | K933518 | Synthes Unreamed Humeral Nail (Urhn)Summary page 150…Conditional Classification Name(s): Rod, Fixation, Intramedullary And Accessories Regulatory Class: Class II; 888.3020 Product Code(s): HSB 1.3. Predicate Device K933518 DePuy Synthes Unreamed Humeral Nail (URHN) 1.4. Device Description The DePuy Synthes URHN is intended to stabilize fractures… | 1994 |
| * | K971783 | Synthes Elastic Intramedullary Nail (Ein) SystemSummary page 152…Nail (EIN) System – MR Conditional Classification Name(s): Pin, Fixation, Smooth Regulatory Class: Class II; 888.3040 Product Code(s): HTY 1.3. Predicate Device K971783 DePuy Synthes Elastic Intramedullary Nail (EIN) System 1.4. Device Description The DePuy Synthes EIN is intended for fixatio… | 1997 |
| * | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS)Summary page 154…System (DRPS) – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): HRS, HWC 1.3. Predicate Device K982732 DePuy Synthes Distal Radius Plate System (DRPS) 1.4. Device Description The DePuy Synthes Distal Radius Plate System consist… | 1998 |
| * | K991407 | Synthes Locking Calcaneal PlatesSummary page 156…cation Name(s): Single/multiple component bone fixation appliances and accessories Regulatory Class: Class II; 888.3030 Product Code(s): HRS 1.3. Predicate Device K991407 DePuy Synthes Calcaneal Plates 1.4. Device Description The DePuy Synthes LCPs are designed to address complex fractures of t… | 1999 |
| * | K992348 | Synthes Spiral Blade for Humeral Nail (SBHN)Summary page 158…Humeral Nail (SBHN) – MR Conditional Classification Name(s): Nail, Fixation, Bone Regulatory Class: Class II; 888.3030 Product Code(s): JDS 1.3. Predicate Device K992348 DePuy Synthes Spiral Blade for Humeral Nail (SBHN) 1.4. Device Description The DePuy Synthes Spiral Blade for Humerus Nail i… | 1999 |
| † | K161489 | Syntorr K-wire and Pin System | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 44 of the 190 ancestors have a recall of any class.
- 8 other devices also cite its predicate K000089.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
The DePuy Synthes 4.0 mm and 5.0 mm Locking Screws are used for the static and dynamic interlocking of femoral, humeral and tibial nails. The DePuy Synthes Wrist Fusion Plates are intended for wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability…
Read the full statement (4,286 words)
The DePuy Synthes 4.0 mm and 5.0 mm Locking Screws are used for the static and dynamic interlocking of femoral, humeral and tibial nails.
The DePuy Synthes Wrist Fusion Plates are intended for wrist arthrodesis and for fractures of other small long bones such as the clavicle and olecranon. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability; post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities.
The DePuy Synthes Large Fragment DCL is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of osteopenic bone and fixation of non-unions or malunions.
The DePuy Synthes Small Fragment DCL system is indicated for the fixation of fractures, osteotomies. and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.
The DePuy Synthes Modular Foot System is intended for fractures, osteotomies, and replantations of small bones including the foot, ankle, and hand.
The DePuy Synthes Locking Compression Plate (LCP) System - T Plate are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. Also for use in fixation of osteopenic bone and fixation of non-unions and malunions.
The DePuy Synthes One-Third Tubular Plate is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, particularly in osteopenic bone as a part of the DePuy Synthes Small Fragment DCL System.
The DePuy Synthes Stainless Steel Modular Hand System is intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.
The DePuy Synthes Ti-15 Mo Locking Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
The DePuy Synthes LCP Proximal Femur Hook Plates are intended for fractures of the femur including: fractures of the trochanteric region, trochanteric simple, cervicotrochanteric, trochanterodiaphyseal, multifragmentary pertrochanteric, intertrochanteric, intertrochanteric reversed, or transverse or with additional fracture of medial cortex. Fractures of the proximal end of the femur combined with ispsilateral shaft fractures, metastatic fracture of the proximal femur and osteotomies of the proximal femur.
The DePuy Synthes Titanium Cannulated Humeral Nail System is intended to aid in the alignment and stabilization of humeral fractures to include: Diaphyseal fractures of the humeral shaft, Fractures of the proximal humerus, Proximal humeral fractures with diaphyseal extension, Impending pathologic fractures, and Malunions and nonunions.
The DePuy Synthes Tibial Nail System Ex is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre- and post -isthmic fractures; and tibial malunions and non-unions.
The DePuy Synthes Curved Broad Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of peri-prosthetic fractures, osteopenic bone and non-unions or malunions.
The DePuy Synthes Curved Condylar Plates are intended for buttressing multifragmentary distal femur fractures, including: supracondylar, intra-articular and extra-articular condylar fractures, peri-prosthetic fractures and fractures in normal or osteopenic bone, nonunions/malunions, and osteotomies of the femur.
The DePuy Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The DePuy Synthes LCP Wrist Fusion Plates are intended for wrist arthrodesis and fractures of other small bones. Specific indications include post-traumatic arthritis of the joints of the wrist; rheumatoid wrist deformities requiring restoration; complex carpal instability; post-septic arthritis of the wrist; severe unremitting wrist pain related to motion; brachial plexus nerve palsies; tumor resection; and spastic deformities.
The DePuy Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large (long) bone and bone fragments.
In addition, the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).
The DePuy Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The DePuy Synthes Modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.
The DePuy Synthes LCP Dia-Meta Volar Distal Radius Plates are indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
The DePuy Synthes VA-LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
The DePuy Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The DePuy Synthes Elastic Intramedullary Nail (EIN) System is indicated for fixation of diaphyseal fractures where the canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-stature patients. This system is also intended to treat metaphyseal and epiphyseal fractures, such as radial neck fractures and is intended for fixation of small long bones, such as carpal and tarsal bones. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The DePuy Synthes 3.5 mm Locking Compression Plate CLCP) System: The Synthes 3.5 mm LCP is indicated for fixation offractures, osteotomies and non-unions ofthe clavicle, scapula, olectranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone for adult patients.
These plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
The DePuy Synthes 4.5 mm Locking Compression Plate CLCP) System: The Synthes 4.5 LCP is indicated for fixation ofvarious long bones, such as the humerus, femur and tibia and for use in fixation of peri-prosthetic fractures, osteopenic bone and fixation of non-unions or malunions in adult patients.
These plates are also indicated for fracture flXation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
The DePuy Synthes 2.4 mm VA-LCP Two-Column Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
The DePuy Synthes 1.5 mm Mini Fragment LCP System is indicated for fixation of small bones and small fragments, osteotomies, arthrodeses, replantations, and reconstructions of small bones and small fragments, particularly in osteopenic bone.
The DePuy Synthes 2.4 mm LCP Volar Column Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures of and osteotomies of the distal radius and other small bones.
The DePuy Synthes Locking Hand Plates are intended for fixation of fractures, osteotomies, non-unions, replantations and fusions of small bones and small bone fragments, particularly in osteopenic bone.
The DePuy Synthes 2.4 mm VA-LCP Two-Column Narrow Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones.
The DePuy Synthes 2.4 mm / 2.7 mm VA-LCP Forefoot / Midfoot System is indicated for fixation of osteotomies, fusions, fractures, non unions, mal unions and replantations of small bones and small bone fragments in adult and adolescent (12- 21 years) patients, including the foot and ankle, and particularly in osteopenic bone.
The DePuy Synthes 2.4 mm LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra:articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
The 2.4 mm LCP Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
The DePuy Synthes 2.4 mm Variable Angle LCP Two-Column Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
The DePuy Synthes 2.4mm Variable Angle LCP Two-Column Narrow Volar Distal Radius Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
The DePuy Synthes Variable Angle LCP Distal Radius System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
The DePuy Synthes Synthes Locking Distal Radius Plating System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
The DePuy Synthes Ti-15Mo Locking Distal Radius Plating System Distal System is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intra-articular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
The DePuy Synthes MultiLoc Proximal Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures.
The DePuy Synthes 2.4 mm V A-LCP Intercarpal Fusion System is indicated for fusion of small bones of the hand including: hamate, capitate, lunate, and triquetrum, for the revision of failed partial wrist fusions, and is indicated for use in patients suffering pain and/or loss of function due to: Osteoarthritis, Rheumatoid arthritis, Post-traumatic or degenerative wrist arthritis, Carpal instability.
The DePuy Synthes 2.4 mm Variable Angle LCP Volar Rim Distal Radius Plates are indicated for fixation of complex intra- and extra-articular fractures of the distal radius and other small bones in adults, skeletally mature adolescents, and the following adolescent distal radius fractures: intraarticular fractures exiting the epiphysis, intra-articular fractures exiting the metaphysis, physeal crush injuries, and any injuries which cause growth arrest to the distal radius.
The DePuy Synthes 3.5 mm Low Profile Cortical Screws are intended for fixation of ITactures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur, and fibula in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
The DePuy Synthes Pediatric LCP Plate System is indicated for fixation of fractures (including pathologic and impending pathologic fractures) and osteotomies of the femur in infants, children, adolescents and small statured adults.
Specific indications for the 100°, 120°, 130°, 140°, 150° plates include:
• Varus, valgus, rotational and/or shortening osteotomies
• Femoral neck and/or pertrochanteric fractures
• Proximal metaphyseal fractures
• Diaphyseal fractures
• Pathologic fractures
• Prophylactic use for impending pathologic fractures
Specific indications for the 90° plates include:
• Varus, valgus, rotational and/or shortening osteotomies
• Femoral neck and/or penrochanteric fractures
• Proximal and distal metaphyseal fractures
• Diaphyseal fractures
• Pathologic fractures
• Prophylactic usc for impending pathologic fractures
The DePuy Synthes 1.0 mm, 1.3 mm, 1.5 mm, 2.0 mm, and 2.4 mm Cortex Screws are intended for use in trauma procedures, reconstructive procedures, and general surgery of the hand, wrist, and other small bones and bone fragments in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 2.7 mm Cortex Screw is intended for fractures and osteotomies of small bones and bone fragments, including the foot, ankle, and hand in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The Synthes 2.7 mm Cortex Screw may also be used in fusion applications in adults and adolescents (12-21 years) when used with the Synthes 2.4 mm / 2.7 mm Variable Angle LCP Forefoot/Midfoot System (K100776) and in adults and pediatric patients (2-12 years) when used with the Synthes Ti Wrist Fusion Plate (K023879).
The DePuy Synthes 3.5 mm and 4.0 mm Cortex Screws are intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneous, femur and fibula in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 4.5 mm Cortex Screw is intended for fixation of various long bones, such as the humerus, femur and tibia. It is also for use in fixation of non-unions or mal unions in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 2.7 mm LCP Ulna Osteotomy System is indicated for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including osteopenic bone in the ulna. The 2.7 mm LCP Ulna Osteotomy System is indicated for use in both adults and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 3.5 mm VA-LCP Proximal Tibia Plates are intended to treat fractures of the proximal tibia in adults and adolescents in which the growth plates have fused including: simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures. Plates can also be used for treatment of nonunions, mal unions, tibial osteotomies and osteopenic bone.
The DePuy Synthes MultiLoc Humeral Nailing System is indicated for fractures of the proximal humerus, including 2-part surgical neck fractures, 3-part fractures, and 4-part fractures, proximal humeral fractures with diaphyseal extension, diaphyseal fractures of the humeral shaft, and impending pathologic humeral fractures.
The DePuy Synthes Variable Angle LCP Ankle Trauma System is intended for fixation of the ankle in adults and adolescents (12-21) in which the growth plates have fused, and particularly in osteopenic bone. Specifically,
• Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, non unions, mal unions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
• Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, non unions, malunions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
The DePuy Synthes 2.7/3.5 mm Variable Angle LCP Ankle Trauma System is intended Indications for Use for fixation of the ankle and is indicated in adults and adolescents ( 12-21) in which the growth plates have fused, and particularly in osteopenic bone.
Specifically,
• Anterolateral Distal Tibia Plates are intended for fixation of osteotomies, fractures, non unions, mal unions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia.
• Medial and Anteromedial Distal Tibia Plates are intended for fixation of osteotomies, fractures, non unions, mal unions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal tibia,
• Distal Tibia T Plates and Distal Tibia L Plates are intended to buttress partial articular fractures and bone fragments of the distal tibia, and
• Lateral Distal Fibula Plates are intended for fixation of osteotomies, fractures, nonunions, mal unions, and replantations of bones and bone fragments of the diaphyseal and metaphyseal regions of the distal fibula.
The DePuy Synthes 2.7 mm and 3.5 mm Variable Angle LCP Midfoot/Hindfoot System is indicated for fixation of osteotomie, fusions, fractures, nonunions, malunions and replantations of small bones and small one fragments in adult and adolescent (12 -21 years) patients, including the foot and ankle, and particularly in osteopenic bone.
The DePuy Synthes 3.5 mm Low Profile Cortical Screws and the Synthes 3.5 mm Cortex Screws are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, hand, radius, ulna, pelvis, tibia, femur, fibula, and foot in adults, and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by the screw fixation.
The DePuy Synthes 4.0 mm Cortex Screws are intended for fixation of fractures, fusions, osteotomies, non‐unions, and malunions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, fibula, and the bones of the foot and hand in adults and in both children (2‐12 years) and adolescents (12‐21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 4.5 mm Cortex Screws are intended for fixation of fractures, fusion, osteotomies, non‐unions, and malunions of various long bones, such as the humerus, femur and tibia; and the bones of the foot and hand in adults and in both children (2‐12 years) and adolescents (12‐21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 2.4 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non‐unions, and malunions of small bones in adults and in both children (2‐12 years) and adolescents (12‐21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non‐unions, and malunions of small bones and small bone fragments in adults and in both children (2‐12 years) and adolescents (12‐21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 4.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non‐unions, and malunions of long bones and long bone fragments; and the bones of the hand and foot, in adults and in both children (2‐12 years) and adolescents (12‐21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 6.5 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non‐unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2‐12 years) and adolescents (12‐21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for femoral neck fractures; slipped capital femoral epiphysis; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodesis; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodesis.
The DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws are intended for fixation of fractures, fusions, osteotomies, non‐unions, and malunions of long bones and long bone fragments, pelvis, sacrum, and the bones of the foot in adults and in both children (2‐12 years) and adolescents (12‐21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation. These screws are also indicated for slipped capital femoral epiphysis; ankle arthrodesis; and subtalar arthrodesis.
The DePuy Synthes 1.5 mm Headless Compression Screws are intended for fixation of intra‐articular and extra‐articular fractures, avulsions, non‐unions, malunions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2‐12 years) and adolescents (12‐21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 2.4 mm Headless Compression Screws are intended for fixation of fractures, osteotomies, non‐unions, and malunions of small bones and small bone arthrodesis in adults and in both children (2‐12 years) and adolescents (12‐21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 3.0 mm Headless Compression Screws are intended for fixation of intra‐articular and extra‐articular fractures, non‐unions, malunions, and osteotomies of small bones and small bone fragments, as well as arthrodesis of small joints in adults and in both children (2‐12 years) and adolescents (12‐21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screws are indicated for fixation of fractures, fusions, osteotomies, non‐unions, and malunions of various bones and bone fragments including bones of the foot, humerus, femur and tibia in adults and in both children (2‐12 years) and adolescents (12‐21 years) in which growth plates have fused or in which growth plates will not be crossed by screw fixation.
The DePuy Synthes Variable Angle Positioning Pins are intended for use with cerclage multifilament cable to augment fracture stabilization with plates used in long bone fixation, when screw placement would be inhibited, as in the presence of intramedullary implant. The Variable Angle Positioning Pins are designed for use with Variable Angle LCP plate implants featuring variable angle locking holes that accept 5.0 mm variable angle bone screws.
The DePuy Synthes Angled Blade Plate is intended for use in femoral fractures and osteotomies. More specifically, the primary intended uses are as follows:
• fractures of the distal and proximal femur
• femoral neck and pertrochanteric fractures
• intertrochanteric femoral osteotomies
• repositioning osteotomy (femoral neck)
The DePuy Synthes Unreamed Humeral Nail (URHN) is generally indicated for Humeral shaft fractures. Specifically,
• Acute humeral shaft fractures;
• Pathologic or impending pathologic fractures;
• Non and malunions of the humeral shaft.
The DePuy Synthes EIN is intended for fixation of diaphyseal fractures of the long bones where the medullary canal is narrow or flexibility of the implant is paramount. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small-statured patients. In pediatric applications, the flexibility of the EIN allows it to be inserted at a point which avoids disruption to the bone growth plate.
The DePuy Synthes Distal Radius Plate System is intended for fixation of fractures, osteotomies, including carpal fusions involving the distal radius applied to the volar and dorsal aspect.
The DePuy Synthes Locking Calcaneal Plates are indicated for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue type and severely comminuted fractures.
The DePuy Synthes Spiral Blade for Humeral Nail is intended to stabilize fractures of the humerus.
The DePuy Synthes Kirschner (K-) Wires and Guide Wires are indicated for use in open and percutaneous fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants, for implantation through the skin, and as traction pins so that traction may be applied to the skeletal system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160553: DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) – MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System –MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System – MR Conditional, DePuy Synthes Modular Foot System – MR Conditional, DePuy Synthes T-Plates – MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) – MR Conditional, DePuy Synthes Stainless S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160553
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026