510(k) · Cleared
ClearedDePuy Synthes Trauma Orthopedic Plates and Screws
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 Nov 1, 2018 as substantially equivalent to K792291 (Synthes (Usa), 1979) and 29 other predicates after a 269-day review. Its family tree reaches back 12 generations to 1996. 4 later devices descend from it.
- Decided
- Nov 1, 2018
- Review
- 269 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 30
Its longest line of descent runs back 12 generations to K962616 (1996). 112 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations between
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 1 generation backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- This deviceK180310 DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
- Descendant · cites it directly · 1 of its ownK243995 Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK190391 TDM Plate and Screw SystemsTdm Co., Ltd. · 2019
- Descendant · cites it directly · 0 of its ownK260353 Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage…Arthrex, Inc. · 2026
- Descendant · 2 generations on · 0 of its ownK241128 TDM Plate and Screw SystemTdm Co., Ltd. · 2024
Show all 12 generations
- Root · 12 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 11 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 10 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 9 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 8 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 7 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 6 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 5 generations backK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- 4 generations backK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- 3 generations backK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- 2 generations backK120070 Synthes Variable Angle LCP Elbow SystemSynthes USA · 2012 · Recalled
- 1 generation backK120717 Synthes Variable Angle LCP Elbow System (Medical and Posterolateral…Synthes USA · 2012
- This deviceK180310 DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025 · cites it directly1descendant
- K190391TDM Plate and Screw SystemsTdm Co., Ltd. · 2019 · cites it directly1descendant
- K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc. · 2026 · cites it directly0descendants
- K241128TDM Plate and Screw SystemTdm Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −11 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −10 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −9 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −8 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −7 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −6 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −5 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| −4 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| −3 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| −2 | K120070 | Synthes Variable Angle LCP Elbow System | Synthes USA | 2012 | 1 |
| −1 | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal… | Synthes USA | 2012 | — |
| 0 (this device) | K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2018 | — |
| +1 | K243995 | Arthrex Humeral Plating System and Cerclage Button | Arthrex, Inc. | 2025 | — |
| +1 | K190391 | TDM Plate and Screw Systems | Tdm Co., Ltd. | 2019 | — |
| +1 | K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | 2026 | — |
| +2 | K241128 | TDM Plate and Screw System | Tdm Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 11 | 0 |
| 2002 | 4 | 0 |
| 2003 | 7 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 7 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (30)
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 |
|---|---|---|---|
| * | K792291 | Synthes Reconstructive Plates 'Y' PlatesSummary page 33…ion,Single Component RegulatoryClass:ClassII,§888.3030 ProductCode(s):KTW 1.3.PredicateDevice K792291SynthesReconstructivePlates'Y'Plates 1.4.DeviceDescription The3.5mmReconstructionPlateisavailableinmul… | 1979 |
| * | K961413 | Synthes Anatomical Locking Plate SystemSummary page 35…lassificationName(s):Screw,Fixation,Bone RegulatoryClass:ClassII,§888.3040 ProductCode(s):HWC,HRS 1.3.PredicateDevice K961413SynthesAnatomicalLockingPlateSystem 1.4.DeviceDescription TheAnatomicalLockingPlateSystemutilizesalocki… | 1996 |
| * | K974537 | Synthes Cannulated Angle Blade Plate (Cabp) SystemSummary page 37…Multiple Component RegulatoryClass:ClassII,§888.3030 ProductCode(s):KTT 1.3.PredicateDevice K974537SynthesCannulatedAngleBladePlate(CABP)System 1.4.DeviceDescription TheCABPisastraightplatewithablade… | 1998 |
| * | K992837 | 3.5 MM 90 Cannulated Limited Contact Angeled Blade Plates (3.5MM 90 Cannulated LC-Abp)Summary page 39…ion,Single Component RegulatoryClass:ClassII,§888.3030 ProductCode(s):KTW 1.3.PredicateDevice K992837Synthes3.5mm90°CannulatedLimitedContactͲAngledBladePlates 1.4.DeviceDescription TheDePuySynthes3.5mm9… | 1999 |
| * | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) SystemSummary page 41…Multiple Component RegulatoryClass:ClassII,§888.3030 ProductCode(s):KTT 1.3.PredicateDevice K000682SynthesLargeFragmentDynamicCompressionLocking(DCL)System 1.4.DeviceDescription TheLargeFragmentDCLsyst… | 2000 |
| * | K010766 | Synthes (Usa) Large Fragment Locking Compression Plate (LCP) System-T PlateSummary page 43…Multiple Component RegulatoryClass:ClassII,§888.3030 ProductCode(s):KTT 1.3.PredicateDevice K010766Synthes(USA)LargeFragmentLockingCompressionPlate(LCP)SystemͲTPlate 1.4.DeviceDescription TheDePuySynt… | 2001 |
| * | K011334 | Synthes Curved Reconstruction PlateSummary page 45…ClassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K011334SynthesCurvedReconstructionPlate 1.4.DeviceDescription TheDePuySynthesCurvedReconstructionPlatelineexten… | 2001 |
| * | K011335 | Synths One-Third Tubular DCL PlateSummary page 47…ClassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K011335SynthesOneͲthirdDCLPlate 1.4.DeviceDescription TheDePuySynthesOneͲThirdTubularDCLPlatelineextensionis… | 2001 |
| * | K011815 | Synthes LCP Proximal Humerus PlatesSummary page 49…n,Single Component RegulatoryClass:ClassII,§888.3030 ProductCode(s):KTW 1.3.PredicateDevice K011815SynthesLCPProximalHumerusPlate 1.4.DeviceDescription TheDePuySynthesLCPProximalHumerusPlatesaredesigne… | 2001 |
| * | K020602 | Synthes Pilon PlateSummary page 51…ClassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K020602SynthesPilonPlate 1.4.DeviceDescription TheDePuySynthesPilonPlateisametalplatethatoffersscrewtoplat… | 2002 |
| * | K023941 | Synthes Tomofix Osteotomy SystemSummary page 53…n,Multiple Component RegulatoryClass:ClassII,§888.3030 ProductCode(s):KTT 1.3.PredicateDevice K023941SynthesTomoFixTMOsteotomySystem 1.4.DeviceDescription TheTomoFixTMOsteotomySystemconsistsoffivedifferent… | 2003 |
| * | K031178 | Synthes (Usa) 3.5 MM Broad LCP & 4.5 MM LCP Distal Humerus PlatesSummary page 55…ClassificationName(s):Plate,Fixation,Bone. RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K0311783.5mmBroadLCP&4.5mmLCPDistalHumerusPlate 1.4.DeviceDescription TheDePuySynthes3.5mmBroadLCP&4.5… | 2003 |
| * | K031677 | Synthes (Usa) Calvicle Hook PlateSummary page 57…ClassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K031677Synthes(USA)ClavicleHookPlate 1.4.DeviceDescription TheDePuySynthesClavicleHookPlateisananatomicallyd… | 2003 |
| * | K033805 | Synthes (Usa) 3.5 / 4.5 MM LCP Metaphyseal PlatesSummary page 59…Component,MetalComposite RegulatoryClass:ClassII,§888.3030 ProductCode(s):LXT 1.3.PredicateDevice K033805Synthes(USA)3.5/4.5mmLCP®MetaphysealPlates 1.4.DeviceDescription TheDePuySynthes3.5/4.5mmLCP®Metap… | 2004 |
| * | K033995 | 3.5 MM LCP Distal Humerus SystemSummary page 61…dedmetallicbonefixationfastener RegulatoryClass:ClassII,§888.3030and§888.3040 ProductCode(s):KTT 1.3.PredicateDevice K0339953.5mmLCPDistalHumerusSystem 1.4.DeviceDescription TheDePuySynthes3.5mmLCPDistalHumerusSystemconsists… | 2004 |
| * | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, LongSummary page 63…d accessories. RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS,HWC 1.3.PredicateDevice K041860Synthes(USA)LCP®ProximalHumerusPlates,Long 1.4.DeviceDescription TheDePuySynthesLCPProximalHumerusPlat… | 2004 |
| * | K041911 | Synthes (Usa) LCP Curved PlatesSummary page 65…esand accessories. RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K041911SynthesLCP®CurvedPlates 1.4.DeviceDescription TheDePuySynthesLCP®CurvedPlateshaveaslightcurvetobette… | 2004 |
| * | K042377 | Synthes Low Profile Reconstruction PlatesSummary page 67…ClassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K042377SynthesLowProfileReconstructionPlates 1.4.DeviceDescription TheDePuySynthes3.5mmLowProfileReconstructio… | 2004 |
| * | K061973 | Synthes 3.5MM Spring PlateSummary page 69…ClassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K061973Synthes3.5mmSpringPlate 1.4.DeviceDescription TheDePuySynthes3.5mmSpringPlateisavariationoftheDePuy… | 2006 |
| * | K082072 | Synthes (Usa) 3.5MM LCP Hook PlateSummary page 71…ClassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K082072Synthes(USA)3.5mmLCPHookPlate 1.4.DeviceDescription TheDePuySynthes3.5mmLCPHookPlateisalowͲprofile,… | 2008 |
| * | K082625 | Synthes (Usa) 3.5MM LCP Periarticular Proximal Humerus PlatesSummary page 73…ClassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K082625Synthes(USA)3.5mmLCPPeriarticularProximalHumerusPlates 1.4.DeviceDescription TheDePuySynthes3.5mmLCP… | 2008 |
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 75…lassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS,HWC 1.3.PredicateDevice K082807Synthes3.5mmand4.5mmLockingCompressionPlate(LCP)Systemwith ExpandedIndications 1.4.DeviceDescription … | 2008 |
| * | K083573 | Synthes (Usa) 3.5MM Locking Attachment PlatesSummary page 77…ClassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K083573Synthes(USA)3.5mmLockingAttachmentPlates 1.4.DeviceDescription TheDePuySynthes3.5mmLockingAttachmentPla… | 2009 |
| * | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)Summary page 79…lassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS,HWC 1.3.PredicateDevice K092609Synthes3.5mmand4.5mmCurvedNarrowandBroadLockingCompression Plates(LCP) 1.4.DeviceDescription The… | 2009 |
| * | K101536 | 2.7/3.5MM VA-LCP Anteriro Clavicle Plate SystemSummary page 81…lassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS,HWC 1.3.PredicateDevice K1015362.7mm/3.5mmVAͲLCPAnteriorClaviclePlateSystem 1.4.DeviceDescription TheDePuySynthes2.7mm/3.5mmVAͲL… | 2010 |
| * | K111540 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 83…ClassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K111540Synthes3.5mmLCPClaviclePlateSystem 1.4.DeviceDescription TheDePuySynthes3.5mmLCPClaviclePlateSystem… | 2011 |
| * | K120070 | Synthes Variable Angle LCP Elbow SystemSummary page 85…lassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS,HWC 1.3.PredicateDevice K120070SynthesVariableAngleLCPElbowSystem 1.4.DeviceDescription TheDePuySynthesVariableAngleLCPElbowSystemco… | 2012 |
| * | K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates)Summary page 87…lassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS,HWC 1.3.PredicateDevice K120717SynthesVariableAngleLCPElbowSystem(MedialandPosterolateralDistal HumerusPlates) 1.4.DeviceDescription … | 2012 |
| * | K141796 | Depuy Synthes Tomofix Osteotomy SystemSummary page 89…onal ClassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K141796DePuySynthesTOMOFIXOsteotomySystem 1.4.DeviceDescription TheDePuySynthesTOMOFIXOsteotomySystemconsists… | 2014 |
| * | K163046 | DePuy Synthes 2.4/2.7mm VA LCP Two-Column Volar Distal Radius Plate, Extra-LongSummary page 91…ClassificationName(s):Plate,Fixation,Bone RegulatoryClass:ClassII,§888.3030 ProductCode(s):HRS 1.3.PredicateDevice K163046DePuySynthes2.4/2.7mmVALCPTwoͲColumnVolarDistalRadiusPlate,ExtraͲ Long 1.4.DeviceDescription TheDeP… | 2017 |
What descends from it? (4)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 22 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 25 of the 112 ancestors have a recall of any class.
- Of its descendants, K243995 (Arthrex, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K792291.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Reconstructive Plates 'Y' Plates are indicated for pelvic and acetabular reconstructive surgery and the reduction of fractures in the distal humerus, the clavicle, and the scapula. The DePuy Synthes Anatomical Locking Plate System is indicated to treat fractures (including but not limited to) the radius, ulna, humerus, tibia, fibula, femur. The DePuy Synthes CABP System is a plate and screw system intended to treat fractures of the…
Read the full statement (1,534 words)
The DePuy Synthes Reconstructive Plates 'Y' Plates are indicated for pelvic and acetabular reconstructive surgery and the reduction of fractures in the distal humerus, the clavicle, and the scapula.
The DePuy Synthes Anatomical Locking Plate System is indicated to treat fractures (including but not limited to) the radius, ulna, humerus, tibia, fibula, femur.
The DePuy Synthes CABP System is a plate and screw system intended to treat fractures of the proximal humerus and distal tibia.
Proximal humerus fractures include two-part greater tubercle fractures and fracture dislocations, two-part surgical neck fractures and fracture dislocations, three-part fractures or fracture dislocations, fractures in osteopenic bone, and nonunions and malunions.
Distal tibia fractures include acute fractures, fractures in osteopenic bone, and nonunions and malunions.
The DePuy Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia.
The DePuy Synthes Large Fragment DCL is intended for fixation of various long bones, such as the humerus, femur and tibia. Also for use in fixation of osteopenic bone and fixation of non-unions or malunions.
The DePuy Synthes Large Fragment Locking Compression Plate (LCP) System - T Plate is 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 Curved Reconstruction 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 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 LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
The DePuy Synthes Pilon Plate is intended for fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia.
DePuy Synthes TomoFix Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia and lateral distal femur, treatment of bone and joint deformities, and malalignment caused by injury or disease such as osteoarthritis.
The DePuy Synthes 3.5 mm Broad LCP & 4.5 mm LCP Distal Humerus Plates are indicated for fractures of the distal humerus.
The DePuy Synthes Clavicle Hook Plate is intended for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.
The DePuy Synthes 3.5 / 4.5 LCP Metaphyseal Plate is intended for fixation of various long bones, excluding the femur. It is also for use in fixation of osteopenic bone and fixation of nonunions or malunions.
The DePuy Synthes 3.5 mm LCP Distal Humerus System is indicated for intraarticular fractures of the distal humerus, commninuted supra-condylar fractures, osteotomies, and non-unions of the distal humerus.
The DePuy Synthes LCP Proximal Humerus Plate, Long is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
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 Low Profile Reconstruction Plates are intended for pelvic and acetabular reconstruction and fixation of fractures of the distal humerus, clavicle, and scapula.
The DePuy Synthes 3.5 mm Spring Plate is intended for pelvic and acetabular reconstructive surgery and fracture fixation of the distal fibula.
The DePuy Synthes 3.5 mm LCP Hook Plate is indicated for fractures, osteotomies and non-unions of small bones including the ulna, radius, tibia and fibula, particularly in osteopenic bone.
The DePuy Synthes 3.5 mm LCP Periarticular Proximal Humerus Plates are indicated for fractures, fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
The DePuy Synthes 3.5 mm Locking Compression Plate (LCP) System:
The DePuy Synthes 3.5 mm LCP is indicated for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, 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 (LCP) System:
The DePuy Synthes 4.5 mm LCP is indicated for fixation of various 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 fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
The DePuy Synthes 3.5mm Locking Attachment Plate is intended for use with DePuy Synthes LCP plates to augment the stabilization of fractures, including periprosthetic fractures and fractures in the presence of intramedullary implants, in the femur, tibia and humerus, particularly in osteopenic bone.
The DePuy Synthes 3.5 mm Curved Narrow and Broad LCP Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia and fibula, particularly in osteopenic bone for adult patients.
The DePuy Synthes 4.5 mm Curved Narrow and Broad LCP Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and non-unions or malunions in adult patients.
The DePuy Synthes 3.5 mm and 4.5 mm Curved Narrow and Broad LCP Plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
The DePuy Synthes 2.7 mm / 3.5 mm VA-LCP Anterior Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
The DePuy Synthes 3.5 mm LCP Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
The DePuy Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused or in which the growth plates will not be crossed by the plate system. Specifically,
- Distal humerus plates are indicated for intra-articular fractures, commninuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
- Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
The DePuy Synthes Variable Angle LCP Elbow System is intended for fixation of fractures of the distal humerus, olecranon and ulna in adults and adolescents (12-21) in which the growth plates have fused or in which the growth plates will not be crossed by the plate system. Specifically,
- Distal humerus plates are indicated for intra-articular fractures, comminuted supracondylar fractures, osteotomies, malunions and non-unions of the distal humerus.
- Olecranon and Proximal ulna plates are indicated for fractures, osteotomies, malunions and non-unions of the olecranon and proximal ulna.
The DePuy Synthes TOMOFIX Osteotomy System is intended for osteotomies, treatment of bone and joint deformities, fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the distal femur and proximal tibia.
Specifically,
-The TOMOFIX Medial Proximal Tibia Plates are indicated for open- and close-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial proximal tibia
-The TOMOFIX Lateral Proximal Tibia Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the lateral proximal tibia
-The TOMOFIX Lateral Distal Femur Plates are indicated for open- and closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the lateral distal femur
-The TOMOFIX Medial Distal Femur Plates are indicated for closed-wedge osteotomies fixation of fractures, and malalignment caused by injury or disease, such as osteoarthritis, of the medial distal femur
The DePuy Synthes 2.4/2.7 mm VA-LCP Two-Column Volar Distal Radius Plate, Extra-Long is intended for intra- and extra-articular fractures, osteotomies, nonunions and malunions of the distal radius, with or without extension into the radial diaphysis in adults and adolescents (12-21) where the growth plates have fused or will not be crossed, and the following adolescent distal radius fractures:
- Intra-articular fractures exiting the epiphysis
- Intra-articular fractures exiting the metaphysis
- Physeal crush injuries
- Any injuries which cause growth arrest to the distal radius
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180310 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180310: DePuy Synthes Trauma Orthopedic Plates and Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180310
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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