510(k) · Cleared
Recalled · Class II · 2016Synthes (Usa) LCP Modular Foot 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 Mar 4, 2005 after a 45-day review. The FDA summary names its predicate without a number. 142 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 4, 2005
- Review
- 45 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 0
142 later devices descend from it, 7 citing it directly.
- This deviceK050110 Synthes (Usa) LCP Modular Foot PlatesSynthes (Usa) · 2005
- Descendant · cites it directly · 135 of its ownK111253 Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011
- Descendant · 2 generations on · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- Descendant · 2 generations on · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- Descendant · 3 generations on · 38 of its ownK141735 Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 31 of its ownK140397 Paralock Plating System / Tuffnek ScrewParagon 28 · 2014
Showing 5 of 142 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 142 · See all- K111253Arthrex Distal Extremity Plate SystemArthrex, Inc. · 2011 · cites it directly135descendants
- K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · 2 generations on91descendants
- K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · 2 generations on71descendants
- K141735Arthrex Ankle Fusion Plating SystemArthrex, Inc. · 2014 · 3 generations on38descendants
- K140397Paralock Plating System / Tuffnek ScrewParagon 28 · 2014 · 2 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050110 | Synthes (Usa) LCP Modular Foot Plates | Synthes (Usa) | 2005 | — |
| +1 | K111253 | Arthrex Distal Extremity Plate System | Arthrex, Inc. | 2011 | — |
| +2 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| +2 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| +3 | K141735 | Arthrex Ankle Fusion Plating System | Arthrex, Inc. | 2014 | 1 |
| +2 | K140397 | Paralock Plating System / Tuffnek Screw | Paragon 28 | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 12 | 0 |
| 2018 | 8 | 0 |
| 2019 | 12 | 0 |
| 2020 | 15 | 0 |
| 2021 | 12 | 0 |
| 2022 | 9 | 0 |
| 2023 | 9 | 0 |
| 2024 | 15 | 0 |
| 2025 | 10 | 0 |
| 2026 | 23 | 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) Modular Foot System Named without a submission number |
What descends from it? (142)
See all 1427 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111253 | Arthrex Distal Extremity Plate System | 2011 | 135 |
| K190391 | TDM Plate and Screw Systems | 2019 | 1 |
| K153374 | CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of… | 2016 | 1 |
| K200575 | Truemed Hand, Foot and Ankle Plates System | 2021 | 0 |
| K190992 | OrthoPediatrics PediFoot Deformity Corrections System | 2019 | 0 |
| K190750 | DePuy Synthes Plates and Screws Portfolio | 2019 | 0 |
| K051162 | Generos SB Small Bone Distraction Implant | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2016 | Class II | Z-2389-2016 | Nonconforming Material/Component | It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature… |
| Nov 2, 2015 | Class II | Z-0323-2016 | Process control | It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K111253 (Arthrex, Inc., 2011) has gone furthest, with 135 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 LCP Modular Foot Plates are intended for use in selective trauma, fractures, osteotomies, reconstructive procedures and replantations of small bones including the foot and ankle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050110 · printed Nov 5, 2026
Cite this page
510(k) Report. “K050110: Synthes (Usa) LCP Modular Foot Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K050110
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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