510(k) · Cleared
ClearedSynthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Synthes · JDP Condylar Plate Fixation Implant
Cleared on Mar 29, 2017 as substantially equivalent to K110354 (Synthes USA, 2011) and 1 other predicate after a 240-day review. Its family tree reaches back 9 generations to 1996. 6 later devices descend from it.
- Decided
- Mar 29, 2017
- Review
- 240 days
- Class
- Class II
- Product code
- JDP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K962616 (1996). 43 ancestors in all, the oldest K890939 (1989). 6 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- 1 generation backK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
- This deviceK162124 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension…DePuy Synthes · 2017
- Descendant · cites it directly · 2 of its ownK172975 DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK243995 Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK260353 Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage…Arthrex, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK231333 STRETTO™ Cable SystemGlobus Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK190750 DePuy Synthes Plates and Screws PortfolioDePuy Synthes · 2019
Show all 9 generations
- Root · 9 generations backK962616 Synthes Dorsal Distal Radius Plate (DDRP) SystemSynthes (Usa) · 1996
- 8 generations backK982732 Synthes (Usa) Distal Radius Plate System (DRPS)Synthes · 1998
- 7 generations backK023007 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2002
- 6 generations backK030198 Hand Innovations, Inc. Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 5 generations backK032705 Distal Radius Fracture Repair SystemHand Innovations, Inc. · 2003
- 4 generations backK050932 Distal Volar Radius Anatomical Plate SystemHand Innovations, Inc. · 2005 · Recalled
- 3 generations backK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- 2 generations backK083286 Orthopediatrics Pediloc Locking Plate SystemOrthoPediatrics Corp. · 2009 · Recalled
- 1 generation backK120689 Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSynthes (USA) Products, LLC · 2012
- This deviceK162124 Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension…DePuy Synthes · 2017
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K172975DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes…Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018 · cites it directly2descendants
- K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025 · 2 generations on1descendant
- K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc. · 2026 · 3 generations on0descendants
- K231333STRETTO™ Cable SystemGlobus Medical, Inc. · 2023 · cites it directly0descendants
- K190750DePuy Synthes Plates and Screws PortfolioDePuy Synthes · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962616 | Synthes Dorsal Distal Radius Plate (DDRP) System | Synthes (Usa) | 1996 | — |
| −8 | K982732 | Synthes (Usa) Distal Radius Plate System (DRPS) | Synthes | 1998 | — |
| −7 | K023007 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2002 | — |
| −6 | K030198 | Hand Innovations, Inc. Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −5 | K032705 | Distal Radius Fracture Repair System | Hand Innovations, Inc. | 2003 | — |
| −4 | K050932 | Distal Volar Radius Anatomical Plate System | Hand Innovations, Inc. | 2005 | 1 |
| −3 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| −2 | K083286 | Orthopediatrics Pediloc Locking Plate System | OrthoPediatrics Corp. | 2009 | 5 |
| −1 | K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate System | Synthes (USA) Products, LLC | 2012 | — |
| 0 (this device) | K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable… | DePuy Synthes | 2017 | — |
| +1 | K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional… | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2018 | — |
| +2 | K243995 | Arthrex Humeral Plating System and Cerclage Button | Arthrex, Inc. | 2025 | — |
| +3 | K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | 2026 | — |
| +1 | K231333 | STRETTO™ Cable System | Globus Medical, Inc. | 2023 | — |
| +1 | K190750 | DePuy Synthes Plates and Screws Portfolio | DePuy Synthes | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 JDP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K110354 | 4.5MM VA-LCP Curved Condylar Plate SystemSummary page 5…ing Pins: Class II /JDQ System-specific Instruments: Class II / JDP, HRS, HWC Predicate Devices: Synthes 4.5mm VA LCP Curved Condylar Plate System (K110354) 3.5 mm VA Locking Positioning Pin (K120689) Reference Devices: Synthes 4.5 mm LCP Plate (K041911)… | 2011 |
| * | K120689 | Synthes 3.5 MM VA-LCP Proximal Tibia Plate SystemSummary page 5…struments: Class II / JDP, HRS, HWC Predicate Devices: Synthes 4.5mm VA LCP Curved Condylar Plate System (K110354) 3.5 mm VA Locking Positioning Pin (K120689) Reference Devices: Synthes 4.5 mm LCP Plate (K041911) Synthes 4.5 mm Broad LCP Plate (K000682)… | 2012 |
| † | K041911 | Synthes (Usa) LCP Curved Plates | 2004 |
| † | K000682 | Synthes Large Fragment Dynamic Compression Locking (DCL) System | 2000 |
| † | K112583 | Synthes Cortical Screws | 2011 |
| † | K000066 | Synthes (Usa) Locking Condylar Plate (LCP) System | 2000 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172975 | DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes… | 2018 | 2 |
| K231333 | STRETTO™ Cable System | 2023 | 0 |
| K190750 | DePuy Synthes Plates and Screws Portfolio | 2019 | 0 |
| K160553 | DePuy Synthes 4.0 mm and 5.0 mm Locking Screws – MR Conditional, DePuy Synthes Wrist… | 2017 | 0 |
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 7 companies; a new generation was cleared every 2.1 years on median.
- 11 of the 43 ancestors have a recall of any class.
- Of its descendants, K172975 (Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc., 2018) has gone furthest, with 2 descendants of its own.
- 5 other devices also cite its predicate K110354.
How does its category compare?
All JDP devicesJDP Condylar Plate Fixation Implant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · JDP
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JDP
Too few JDP 510(k)s in any year since 2007 to give a median.
Recalls per year · JDP
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JDP
41in 2025
MAUDE reports naming product code JDP, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 21 |
| 2013 | 0 | — | 1 | 83 |
| 2014 | 0 | — | 0 | 55 |
| 2015 | 0 | — | 0 | 97 |
| 2016 | 0 | — | 0 | 117 |
| 2017 | 1 | — | 0 | 46 |
| 2018 | 0 | — | 0 | 56 |
| 2019 | 0 | — | 0 | 49 |
| 2020 | 0 | — | 0 | 56 |
| 2021 | 0 | — | 0 | 79 |
| 2022 | 0 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 29 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synthes 4 5mm VA LCP Curved Condylar Plate System is indicated for buttressing multifragmentary distal femur in normal or osteopenic bone, nonunions and malunions.
The DePuy Synthes Vanable 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.
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/K162124 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162124: Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle Positioning Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162124
Report an extraction error
Are you the manufacturer?
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