510(k) · Cleared
Recalled · Class II · 20144.5MM VA-LCP Curved Condylar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes USA · JDP Condylar Plate Fixation Implant
Cleared on Mar 4, 2011 as substantially equivalent to K083025 (Synthes (Usa), 2009) and 4 other predicates after a 25-day review. Its family tree reaches back 2 generations to 1998. 62 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 4, 2011
- Review
- 25 days
- Class
- Class II
- Product code
- JDP
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 2 generations to K982222 (1998). 6 ancestors in all. 62 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK982222 Synthes (Usa) Distal Femur Plate (DFP) SystemSynthes (Usa) · 1998
- 1 generation backK000066 Synthes (Usa) Locking Condylar Plate (LCP) SystemSynthes (Usa) · 2000
- This deviceK110354 4.5MM VA-LCP Curved Condylar Plate SystemSynthes USA · 2011
- Descendant · cites it directly · 44 of its ownK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- Descendant · 2 generations on · 23 of its ownK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- Descendant · 3 generations on · 15 of its ownK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- Descendant · 4 generations on · 14 of its ownK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
- Descendant · 2 generations on · 8 of its ownK143061 Activ Ankle Locking Plating SystemNewclip Technics · 2015
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012 · cites it directly44descendants
- K143385Acumed Ankle Plating SystemAcumed, LLC · 2015 · 2 generations on23descendants
- K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015 · 3 generations on15descendants
- K181113CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018 · 4 generations on14descendants
- K143061Activ Ankle Locking Plating SystemNewclip Technics · 2015 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K982222 | Synthes (Usa) Distal Femur Plate (DFP) System | Synthes (Usa) | 1998 | — |
| −1 | K000066 | Synthes (Usa) Locking Condylar Plate (LCP) System | Synthes (Usa) | 2000 | — |
| 0 (this device) | K110354 | 4.5MM VA-LCP Curved Condylar Plate System | Synthes USA | 2011 | — |
| +1 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| +2 | K143385 | Acumed Ankle Plating System | Acumed, LLC | 2015 | — |
| +3 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | — |
| +4 | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | — |
| +2 | K143061 | Activ Ankle Locking Plating System | Newclip Technics | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 5 | 0 |
| 2021 | 7 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 0 |
| 2026 | 9 | 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? (5)
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 |
|---|---|---|---|
| * | K083025 | Synthes 4.5 MM VA-LCP Curved Condylar SystemSummary page 1…bone fixation fastener. Predicate Devices: Synthes 4 .Smm VA-LCP Curved Condylar Plates (1(083025) Synthes Locking Condylar Plate (LCP) System (1(000066) Synthes LCP Curved Pl… | 2009 |
| * | K000066 | Synthes (Usa) Locking Condylar Plate (LCP) SystemSummary page 1…tion fastener. Predicate Devices: Synthes 4 .Smm VA-LCP Curved Condylar Plates (1(083025) Synthes Locking Condylar Plate (LCP) System (1(000066) Synthes LCP Curved Plates (K(04191 1) Synthes SS/Ti LCP Distal Femur Plate (… | 2000 |
| * | K041911 | Synthes (Usa) LCP Curved Plates | 2004 |
| * | K062564 | Synthes LCP Distal Femur PlatesSummary page 1…Condylar Plate (LCP) System (1(000066) Synthes LCP Curved Plates (K(04191 1) Synthes SS/Ti LCP Distal Femur Plate (K(062564) Synthes 4 .O/5.Omm Peni-Prosthetic Locking Screws… | 2006 |
| * | K041533 | Synthes (Usa) [Synthes} Peri-Prosthetic ScrewsSummary page 1…Plate (K(062564) Synthes 4 .O/5.Omm Peni-Prosthetic Locking Screws (K041533) Device Description: The Synthes 4.5mm VA-LCP Curved Condylar Plate… | 2004 |
What descends from it? (62)
See all 626 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120854 | Synthes VA LCP Ankle Trauma System | 2012 | 44 |
| K141527 | Depuy Synthes Variable Angle Locking Hand System | 2015 | 7 |
| K162124 | Synthes 4.5mm VA-LCP Curved Condylar Plate System Line Extension, Variable Angle… | 2017 | 6 |
| K121601 | Synthes 2.7/3.5MM Variable Angle LCP Ankle Trauma System-Anterolateral Distal Tibia Plate | 2012 | 6 |
| K140119 | Emerge Medical Periarticular and Locking Large Fragment System | 2014 | 1 |
| K141825 | IDEAL Locking Plate System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 5, 2014 | Class II | Z-1125-2014 | Employee error | Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert). |
| May 29, 2013 | Class II | Z-0401-2014 | Employee error | A plate was inadvertently released to a sales consultant that was restricted for sale. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K120854 (Synthes USA, 2012) has gone furthest, with 44 descendants of its own.
- 2 other devices also cite its predicate K083025.
How does its category compare?
All JDP devicesJDP Condylar Plate Fixation Implant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 mutifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nontunions and malunions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110354 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110354: 4.5MM VA-LCP Curved Condylar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110354
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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