510(k) · Cleared
ClearedAce Humerus & Radius Plates
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ace Medical Co. · HRS Plate, Fixation, Bone
Cleared on Apr 1, 1996 after a 123-day review. The FDA summary names its predicate without a number. 28 later devices descend from it.
- Decided
- Apr 1, 1996
- Review
- 123 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
28 later devices descend from it, 3 citing it directly.
- This deviceK955472 Ace Humerus & Radius PlatesAce Medical Co. · 1996
- Descendant · cites it directly · 17 of its ownK143697 Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015 · Recalled
- 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 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K143697Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015 · cites it directly17descendants
- 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) | K955472 | Ace Humerus & Radius Plates | Ace Medical Co. | 1996 | — |
| +1 | K143697 | Biomet Proximal Humerus Plating System | Biomet Manufacturing | 2015 | 18 |
| +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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | — | DePuy ORIF Small Fragment Plates Named without a submission number | |
| * | — | Synthes Small Plates Named without a submission number | |
| * | — | Synthes Small Titanium Plates Named without a submission number |
What descends from it? (28)
See all 283 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, K143697 (Biomet Manufacturing, 2015) has gone furthest, with 17 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 Distal Radius Plate System is designed for internal fixation of the distal radius. The distal radius plates are available in left and right volar configurations and in two sizes, small and large.
The Humerus Plate System is designed for internal fixation of the proximal humerus. The humerus plates are available in right and left configurations and in three hole and five hole length.
Cortical and cancellous bone screws are required to secure the plates to the bone. A variety of screw are available for this application in order to accommodate different fracture types and locations. bone density and surgeon preference.
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/K955472 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955472: Ace Humerus & Radius Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955472
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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