510(k) · Cleared
ClearedSynthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates
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 Apr 26, 2005 after a 43-day review. The FDA summary names its predicate without a number. 37 later devices descend from it.
- Decided
- Apr 26, 2005
- Review
- 43 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
37 later devices descend from it, 8 citing it directly.
- This deviceK050646 Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia PlatesSynthes (Usa) · 2005
- Descendant · cites it directly · 26 of its ownK141121 Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2014
- Descendant · 2 generations on · 25 of its ownK153379 AxSOS 3TiStryker GmbH · 2016
- Descendant · 3 generations on · 24 of its ownK162439 AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017
- Descendant · 3 generations on · 17 of its ownK172350 AxSOS 3 TiStryker GmbH · 2017
- Descendant · 4 generations on · 11 of its ownK181091 AxSOS 3 TiStryker GmbH · 2018
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K141121Axsos 3 TI Locking Plate SystemStryker Trauma AG · 2014 · cites it directly26descendants
- K153379AxSOS 3TiStryker GmbH · 2016 · 2 generations on25descendants
- K162439AxSOS 3 Ti; Stryker Plating SystemStryker GmbH · 2017 · 3 generations on24descendants
- K172350AxSOS 3 TiStryker GmbH · 2017 · 3 generations on17descendants
- K181091AxSOS 3 TiStryker GmbH · 2018 · 4 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050646 | Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates | Synthes (Usa) | 2005 | — |
| +1 | K141121 | Axsos 3 TI Locking Plate System | Stryker Trauma AG | 2014 | — |
| +2 | K153379 | AxSOS 3Ti | Stryker GmbH | 2016 | — |
| +3 | K162439 | AxSOS 3 Ti; Stryker Plating System | Stryker GmbH | 2017 | — |
| +3 | K172350 | AxSOS 3 Ti | Stryker GmbH | 2017 | — |
| +4 | K181091 | AxSOS 3 Ti | Stryker GmbH | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 9 | 0 |
| 2024 | 4 | 0 |
| 2025 | 6 | 0 |
| 2026 | 5 | 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? (1)
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 (USA) 3.5 / 4.5mm LCP Medial Proximal Tibia Plates Named without a submission number |
What descends from it? (37)
See all 378 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141121 | Axsos 3 TI Locking Plate System | 2014 | 26 |
| K140357 | Oic Variable Angle Small Fragment Locking Plate System | 2014 | 2 |
| K132554 | Aap Loqteq Proximal Medial Tibia Plate 3.5 | 2013 | 1 |
| K260069 | DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System | 2026 | 0 |
| K243469 | Signex | 2025 | 0 |
| K250155 | Xpert Knee | 2025 | 0 |
| K201917 | Piccolo Composite Proximal Tibia Plate System | 2020 | 0 |
| K190750 | DePuy Synthes Plates and Screws Portfolio | 2019 | 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?
- Of its descendants, K141121 (Stryker Trauma AG, 2014) has gone furthest, with 26 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.
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 (USA) 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050646: Synthes (Usa) 3.5/4.5MM LCP Medial Proximal Tibia Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050646
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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