510(k) · Cleared
ClearedSynthes 4.5 MM VA-LCP Curved Condylar System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HRS Plate, Fixation, Bone
Cleared on Jan 14, 2009 after a 96-day review. The FDA summary names its predicate without a number. 68 later devices descend from it.
- Decided
- Jan 14, 2009
- Review
- 96 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
68 later devices descend from it, 3 citing it directly.
- This deviceK083025 Synthes 4.5 MM VA-LCP Curved Condylar SystemSynthes (Usa) · 2009
- Descendant · cites it directly · 62 of its ownK110354 4.5MM VA-LCP Curved Condylar Plate SystemSynthes USA · 2011 · Recalled
- Descendant · 2 generations on · 44 of its ownK120854 Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012
- Descendant · 3 generations on · 23 of its ownK143385 Acumed Ankle Plating SystemAcumed, LLC · 2015
- Descendant · 4 generations on · 15 of its ownK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- Descendant · 5 generations on · 14 of its ownK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
Showing 5 of 68 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 68 · See all- K1103544.5MM VA-LCP Curved Condylar Plate SystemSynthes USA · 2011 · cites it directly62descendants
- K120854Synthes VA LCP Ankle Trauma SystemSynthes USA · 2012 · 2 generations on44descendants
- K143385Acumed Ankle Plating SystemAcumed, LLC · 2015 · 3 generations on23descendants
- K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015 · 4 generations on15descendants
- K181113CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018 · 5 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K083025 | Synthes 4.5 MM VA-LCP Curved Condylar System | Synthes (Usa) | 2009 | — |
| +1 | K110354 | 4.5MM VA-LCP Curved Condylar Plate System | Synthes USA | 2011 | 2 |
| +2 | K120854 | Synthes VA LCP Ankle Trauma System | Synthes USA | 2012 | — |
| +3 | K143385 | Acumed Ankle Plating System | Acumed, LLC | 2015 | — |
| +4 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | — |
| +5 | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 6 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 6 | 0 |
| 2019 | 5 | 0 |
| 2020 | 6 | 0 |
| 2021 | 7 | 0 |
| 2022 | 3 | 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 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? (4)
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 |
|---|---|---|---|
| * | — | Synthes 4.5 mm Curved Broad LCP Plates Named without a submission number | |
| * | — | Synthes Locking Condylar Plates Named without a submission number | |
| * | — | Synthes Condylar Buttress Plate Named without a submission number | |
| * | — | Synthes 4.5 mm Broad DCP Plates Named without a submission number |
What descends from it? (68)
See all 683 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?
- Of its descendants, K110354 (Synthes USA, 2011) has gone furthest, with 62 descendants of its own.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Synthes 4.5 mm VA-LCP Curved Condylar System is intended for buttressing multi-fragmentary distal femur fractures including: supracondylar, intra-articular and extra-articular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, and non-unions and malunions.
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/K083025 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083025: Synthes 4.5 MM VA-LCP Curved Condylar System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083025
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