510(k) · Cleared
ClearedDePuy Synthes Plates and Screws Portfolio
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Synthes · HRS Plate, Fixation, Bone
Cleared on Jun 21, 2019 as substantially equivalent to K162124 (DePuy Synthes, 2017) and 28 other predicates after an 88-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Jun 21, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 29
Its longest line of descent runs back 10 generations to K962616 (1996). 66 ancestors in all, the oldest K791619 (1979). No later device cites it as a predicate yet.
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- 2 generations backK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
- 1 generation backK162124 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension…DePuy Synthes · 2017
- This deviceK190750 DePuy Synthes Plates and Screws PortfolioDePuy Synthes · 2019
Show all 10 generations
- Root · 10 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 9 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 8 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 7 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 6 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 4 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 3 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- 2 generations backK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
- 1 generation backK162124 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension…DePuy Synthes · 2017
- This deviceK190750 DePuy Synthes Plates and Screws PortfolioDePuy Synthes · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −9 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −8 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −7 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −6 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −4 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −3 | K083286 | Orthopediatrics Pediloc Locking Plate System | OrthoPediatrics Corp. | 2009 | 5 |
| −2 | K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate System | Synthes (USA) Products, LLC | 2012 | — |
| −1 | K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable… | DePuy Synthes | 2017 | — |
| 0 (this device) | K190750 | DePuy Synthes Plates and Screws Portfolio | DePuy Synthes | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2000 | 8 | 0 |
| 2001 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 6 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 6 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 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? (29)
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 |
|---|---|---|---|
| * | K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle…Summary page 34…e Extension – MR Conditional Classification Name(s): Condylar Plate Fixation Implant Regulatory Class: Class II Product Code(s): JDP, HWC 1.3. Predicate Device K162124 - Synthes 4.5mm VA LCP Curved Condylar Plate System Line Extension 1.4. Device Description The DePuy Synthes 4.5mm VA LCP… | 2017 |
| * | K093928 | Synthes 3.5MM Quadrilateral Surface PlatesSummary page 36…adrilateral Surface Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K093928 - SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES 1.4. Device Description DePuy Synthes 3.5mm Quadrilateral Surface Plates cons… | 2010 |
| * | K083213 | Synthes 2.7 MM/3.5 MM LCP Distal Fibula PlatesSummary page 38…Distal Fibula Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS, HWC 1.3. Predicate Device K083213 - SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES 1.4. Device Description DePuy Synthes 2.7 mm/3.5 mm LCP Distal Fibula Pla… | 2008 |
| * | K082624 | Synthes (Usa) 3.5MM LCP Posteromedial Proximal Tibia PlatesSummary page 40…dial Proximal Tibia Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K082624 - SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES 1.4. Device Description The DePuy Synthes 3.5mm LCP Posterom… | 2008 |
| * | K081353 | Synthes (Usa) Tomofix Medial Distal Femur PlatesSummary page 42…Medial Distal Femur Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K081353 - SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES 1.4. Device Description The DePuy Synthes TomnoFiX Medial Distal Femur… | 2008 |
| * | K080522 | Synthes 3.5 MM LCP Distal Tibia T PlatesSummary page 44…LCP Distal Tibia T Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K080522 - SYNTHES 3.5MM LCP DISTAL TIBIA T PLATES 1.4. Device Description DePuy Synthes 3.5 mm LCP Distal Tibia T Plates are conto… | 2008 |
| * | K071264 | Synthes (Usa) 2.4/2.7 MM Locking Foot ModuleSummary page 46…2.7 mm Locking Foot Module – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K071264 - SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE 1.4. Device Description DePuy Synthes 2.4/2.7 mm Locking Foot Module consis… | 2007 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 48…es LCP Distal Femur Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K062564 - SYNTHES LCP DISTAL FEMUR PLATES 1.4. Device Description DePuy Synthes LCP Distal Femur Plates are part of the Synthes Lo… | 2006 |
| * | K061940 | Synthes LCP Ankle Arthrodesis PlatesSummary page 50…P Ankle Arthrodesis Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K061940 - DePuy Synthes LCP Ankle Arthrodesis Plates 1.4. Device Description DePuy Synthes LCP Ankle Arthrodesis Plates are minima… | 2006 |
| * | K052390 | Synthes LCP Proximal Tibia Plates Line ExtensionSummary page 52…ibia System Line Extension – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K052390 - SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION 1.4. Device Description The DePuy Synthes LCP Proximal Tibia System are… | 2005 |
| * | K050646 | Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSummary page 54…dial Proximal Tibia Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K050646 - SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES 1.4. Device Description The DePuy Synthes (USA) 3.5 / 4.5 mm LC… | 2005 |
| * | K050110 | Synthes (Usa) LCP Modular Foot PlatesSummary page 56…es LCP Modular Foot Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K050110 - SYNTHES (USA) LCP MODULAR FOOT PLATES 1.4. Device Description DePuy Synthes LCP Modular Foot Plates consist of locking c… | 2005 |
| * | K033556 | Synthes (Usa) LCP Dynamic Helical Hip SystemSummary page 58…ssification Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Regulatory Class: Class II Product Code(s): KTT 1.3. Predicate Device K033556 - SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM 1.4. Device Description DePuy Synthes LCP Dynamic Helical Hip System is a p… | 2004 |
| * | K032032 | Synthes (Usa) LCP Proximal Femur Hook PlatesSummary page 60…Proximal Femur Hook Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K032032 - SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES 1.4. Device Description The DePuy Synthes LCP Proximal Femur Hook Plates ar… | 2003 |
| * | K031573 | Synthes 3.5 MM Low Profile Pelvic Reconstruction PlateSummary page 62…cation Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Regulatory Class: Class II Product Code(s): KTT, HRS 1.3. Predicate Device K031573 - SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE 1.4. Device Description DePuy Synthes 3.5 mm Low Profile Pelvic R… | 2003 |
| * | K030858 | Synthes (Usa) LCP Proximal Femur Plate and ScrewsSummary page 64…Proximal Femur Plate – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS, HWC 1.3. Predicate Device K030858 - SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS 1.4. Device Description The DePuy Synthes LCP Proximal Femur Plate are… | 2003 |
| * | K030597 | Synthes 3.5MM Titanium LCP Proximal Tibia PlatesSummary page 66…CPTM Proximal Tibia Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K030597 - SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES 1.4. Device Description The DePuy Synthes 3.5mm Titanium LCPTM Proximal… | 2003 |
| * | K023802 | Synthes 4.5 MM Titanium LCP Proximal Tibia Plating SystemSummary page 68…ximal Tibia Plating System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K023802 - SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM 1.4. Device Description The DePuy Synthes Titanium 4.5mm LCP P… | 2003 |
| * | K013248 | Synthes LCP Distal Tibia PlatesSummary page 70…ression Plate (LCP) System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K013248 - SYNTHES LCP DISTAL TIBIA PLATES 1.4. Device Description The DePuy Synthes Locking Compression Plate (LCP) System are mac… | 2001 |
| * | K011978 | Synthes LCP Proximal Tibia PlateSummary page 72…LCP Proximal Tibia Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K011978 - SYNTHES LCP PROXIMAL TIBIA PLATE 1.4. Device Description The DePuy Synthes LCP Proximal Tibia Plates are contoured to ma… | 2001 |
| * | K010321 | Modular Foot System - 2.7 MM ModuleSummary page 74…lassification Name(s): Appliance, Fixation, Nail/Blade/Plate Combination, Single Component Regulatory Class: Class II Product Code(s): KTW 1.3. Predicate Device K010321 - MODULAR FOOT SYSTEM - 2.7 MM MODULE 1.4. Device Description The DePuy Synthes Modular Foot System - 2.7 mm Module is a s… | 2001 |
| * | K001945 | Synthes (Usa) Medial Distal Tibia PlatesSummary page 76…al Distal Tibia Plates are – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K001945 - SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES 1.4. Device Description DePuy Synthes Medial Distal Tibia Plates are available… | 2000 |
| * | K000066 | Synthes (Usa) Locking Condylar Plate (LCP) SystemSummary page 80…ibia Plates – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS, HTY, HWC, JDW 1.3. Predicate Device K000066 - SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM 1.4. Device Description DePuy Synthes (USA) 3.5/4.5 mm LCP Medial Prox… | 2000 |
| * | K991407 | Synthes Locking Calcaneal PlatesSummary page 82…s): Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Regulatory Class: Class II Product Code(s): LXT 1.3. Predicate Device K991407 - SYNTHES LOCKING CALCANEAL PLATES 1.4. Device Description DePuy Synthes LCPs are designed to address complex fractures of… | 1999 |
| * | K983787 | Synthes Proximal Tibia Plating SystemSummary page 84…ximal Tibia Plating System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K983787 - SYNTHES PROXIMAL TIBIA PLATING SYSTEM 1.4. Device Description The DePuy Synthes Proximal Tibia Plating System consists o… | 1999 |
| * | K964259 | Synthes (Usa) DDHS/DCS System ModificationSummary page 86…– MR Conditional Classification Name(s): Device, Fixation, Proximal Femoral, Implant Regulatory Class: Class II Product Code(s): JDO, KTT 1.3. Predicate Device K964259 - SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION 1.4. Device Description The DePuy Synthes DHSIDCS One-Step Lag Screws have a… | 1997 |
| * | K963325 | Synthes Titanium (TI) Alloy High Tibial Osteotomy (Hto) SystemSummary page 88…Titanium Alloy HTO System – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K963325 - SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM 1.4. Device Description DePuy Synthes Titanium Alloy HTO… | 1997 |
| * | K791619 | Dynamic Hip ScrewSummary page 90…Synthes Dynamic Hip Screw – MR Conditional Classification Name(s): Plate, Fixation, Bone Regulatory Class: Class II Product Code(s): KTT 1.3. Predicate Device K791619 - DYNAMIC HIP SCREW 1.4. Device Description 1.5. Indications for Use The DePuy Synthes DHS is indicated for the fol… | 1979 |
| * | K063049 | Synthes (Usa) Modular Mini Fragment LCP SystemSummary page 92…Classification Name(s): Single/multiple component bone fixation appliances and accessories Regulatory Class: Class II Product Code(s): HRS 1.3. Predicate Device K063049 – DEPUY SYNTHES MODULAR MINI FRAGMENT LCP SYSTEM 1.4. Device Description The plate has six holes in the shaft and one hole… | 2006 |
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 23 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 13 of the 66 ancestors have a recall of any class.
- 3 other devices also cite its predicate K162124.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 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 4.5mm VA LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar…
Read the full statement (1,257 words)
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 4.5mm VA LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
DePuy Synthes 3.5mm Quadrilateral Surface Plates are indicated for quadrilateral surface comminution associated with acetabular fractures when used in conjunction with Synthes pelvic reconstruction plates.
The DePuy Synthes 2.7 mm / 3.5 mm LCP Distal Fibula Plates are indicated for fractures, osteotomies, and non-unions of the metaphyseal and diaphyseal region of the distal fibula, especially in osteopenic bone.
DePuy Synthes 3.5mm LCP Posteromedial Proximal Tibia Plates are indicated for internal fixation of posteromedial proximal tibia fractures including buttressing of fractures of the proximal, distal, and metaphyseal areas of the tibia.
DePuy Synthes TornoFiX Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.
The DePuy Synthes LCP Distal Tibia T Plates are indicated for fractures, osteotomies, and non-unions of the distal tibia, especially in osteopenic bone.
The DePuy Synthes 2.4/2.7 mm Locking Foot Module is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, including the foot and ankle, particularly in osteopenic bone.
DePuy Synthes LCP Distal Femur Plates are intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar, periprosthetic fractures and fractures in normal or osteopenic bone, nonunions and malunions, and osteotomies of the femur.
DePuy Synthes LCP Ankle Arthrodesis Plates are intended for arthrodesis of the ankle joint and distal tibia.
The DePuy Synthes LCP Proximal Tibia System is intended for treatment of nonunions, malunions, osteopenic bone, tibial osteotomies (4.5mm plate only), and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar combination of lateral wedge and depression, periprosthetic, and fractures with associated shaft fractures.
The DePuy Synthes 3.5 / 4.5mm LCP Medial Proximal Tibia Plates are intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia. The 4.5mm version may also be used for fixation of nonunions and malunions of the medial proximal tibia and tibia shaft, as well as opening and closing wedge tibial osteotomies.
The DePuy Synthes LCP Modular Foot Plates are intended for use in selective trauma, fractures, osteotomies, reconstructive procedures and replantations of small bones including the foot and ankle.
The DePuy Synthes LCP Dynamic Helical Hip System is intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
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.
DePuy Synthes 3.5 Low Profile Pelvic Reconstruction Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal humerus, clavicle, and scapula.
DePuy Synthes LCP Proximal Femur Plate is 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.
DePuy Synthes 3.5mm Titanium LCP Proximal Tibia Plate is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
The DePuy Synthes Titanium 4.5 mm LCP Proximal Tibia Plating System is intended for treatment of nonunions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression medial wedge, bicondylar, combination of lateral wedge and depression, and fractures with associated shaft fracture.
The DePuy Synthes Locking Compression Plate (LCP) System 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. The DePuy Synthes LCP Distal Tibia Plates are intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia and other small bones as a part of the DePuy Synthes Small Fragment LCP System.
The DePuy Synthes LCP Proximal Tibia Plate is intended for treatment of non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
The DePuy Synthes Modular Foot System - 2.7 mm Module is intended for fractures, osteotomies, fusions and replantations of small bones including the foot, ankle, and hand.
DePuy Synthes Medial Distal Tibia Plates are indicated for the fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular, intraarticular and distal tibia fractures with a shaft extension, malleolar and distal fibular fractures.
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 Condylar Plate (LCP) System is intended for buttressing multifragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, fractures in normal or osteopenic bone, and non-unions and malunions.
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 Proximal Tibia Plating System is intended for non-unions, malunions, and fractures of the proximal tibia, including simple, comminuted, lateral wedge, depression, medial wedge, bicondylar, combinations of lateral wedge and depression, and fractures with associated shaft fractures.
DePuy Synthes DHS/DCS One-Step Lag Screws are designed for use with the Dynamic Hip Screw (DHS) Plates and Dynamic Condylar Screw (DCS) Plates. They are intended to treat stable and unstable intertrochanteric, subtrochanteric and basilar neck fractures in which a stable medial buttress can be reconstructed.
DePuy Synthes Titanium Alloy High Tibial Osteotomy (HTO) System is an instrument and implant system intended to correct leg malalignments causing unicompartmental osteoarthritis, by correction of the tibial component. It utilizes a locking feature that secures the screw to the plate, enabling stable fixation to be achieved via unicortical or bicortical fixation.
The DePuy Synthes DHS is indicated for the following fractures of the proximal femur:
« Intertrochanteric fractures
« Subtrochanteric fractures
» Basilar neck fractures
The DHS is indicated for stable fractures, and unstable fractures in which a stable medial buttress can be reconstructed.
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190750 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190750: DePuy Synthes Plates and Screws Portfolio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190750
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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