510(k) · Cleared
ClearedSynthes (Usa) 3.5 MM Broad LCP & 4.5 MM LCP Distal Humerus 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 May 5, 2003 after a 21-day review. The FDA summary names its predicate without a number. 41 later devices descend from it.
- Decided
- May 5, 2003
- Review
- 21 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
41 later devices descend from it, 2 citing it directly.
- This deviceK031178 Synthes (Usa) 3.5 MM Broad LCP & 4.5 MM LCP Distal Humerus PlatesSynthes (Usa) · 2003
- Descendant · cites it directly · 35 of its ownK041965 Arthrex Humeral Fracture Plates and ScrewsArthrex, Inc. · 2004
- Descendant · 2 generations on · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 3 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- Descendant · 3 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K041965Arthrex Humeral Fracture Plates and ScrewsArthrex, Inc. · 2004 · cites it directly35descendants
- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on14descendants
- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 3 generations on11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 3 generations on10descendants
- K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031178 | Synthes (Usa) 3.5 MM Broad LCP & 4.5 MM LCP Distal Humerus Plates | Synthes (Usa) | 2003 | — |
| +1 | K041965 | Arthrex Humeral Fracture Plates and Screws | Arthrex, Inc. | 2004 | — |
| +2 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +3 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +3 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| +3 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 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 3.5 mm LCP Reconstruction Plate Named without a submission number |
What descends from it? (41)
See all 412 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, K041965 (Arthrex, Inc., 2004) has gone furthest, with 35 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 3.5 mm Broad LCP & 4.5 mm LCP Distal Humerus Plates are indicated for fractures of the Distal Humerus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031178: Synthes (Usa) 3.5 MM Broad LCP & 4.5 MM LCP Distal Humerus Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031178
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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