510(k) · Cleared
Recalled · Class II · 2020Biomet Proximal Humerus Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Manufacturing · HRS Plate, Fixation, Bone
Cleared on Mar 30, 2015 as substantially equivalent to K955472 (Ace Medical Co., 1996) and 2 other predicates after a 96-day review. Its family tree reaches back 3 generations to 2004. 17 later devices descend from it. It has been recalled 18 times.
- Decided
- Mar 30, 2015
- Review
- 96 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 18
- Predicates
- 3
Its longest line of descent runs back 3 generations to K042059 (2004). 10 ancestors in all, the oldest K882831 (1988). 17 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK042059 Shoulder Fixation SystemHand Innovations, Inc. · 2004
- 2 generations backK051728 Modification to Shoulder Fixation SystemHand Innovations, LLC · 2005
- 1 generation backK060290 Shoulder Fixation SystemHand Innovations, LLC · 2006
- This deviceK143697 Biomet Proximal Humerus Plating SystemBiomet Manufacturing · 2015
- Descendant · cites it directly · 14 of its ownK163361 ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- Descendant · 3 generations on · 7 of its ownK212433 Anthem Fracture SystemGlobus Medical, Inc. · 2021
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K163361ANTHEM™ Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly14descendants
- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · 2 generations on11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 2 generations on10descendants
- K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 2 generations on8descendants
- K212433Anthem Fracture SystemGlobus Medical, Inc. · 2021 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042059 | Shoulder Fixation System | Hand Innovations, Inc. | 2004 | — |
| −2 | K051728 | Modification to Shoulder Fixation System | Hand Innovations, LLC | 2005 | — |
| −1 | K060290 | Shoulder Fixation System | Hand Innovations, LLC | 2006 | — |
| 0 (this device) | K143697 | Biomet Proximal Humerus Plating System | Biomet Manufacturing | 2015 | — |
| +1 | K163361 | ANTHEM™ Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| +2 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| +3 | K212433 | Anthem Fracture System | Globus Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K955472 | Ace Humerus & Radius PlatesSummary page 4…appliancesandaccessories(21CFR888.3030) Legallymarketeddevicestowhichsubstantialequivalenceisclaimed: x ACEProximalHumerusPlatesK955472 x S3ShoulderPlatingSystemK060290 x AnatomicLockedPlatingSystemLongPlateLineExtensionK101421 DeviceDes… | 1996 |
| * | K060290 | Shoulder Fixation SystemSummary page 4…(21CFR888.3030) Legallymarketeddevicestowhichsubstantialequivalenceisclaimed: x ACEProximalHumerusPlatesK955472 x S3ShoulderPlatingSystemK060290 x AnatomicLockedPlatingSystemLongPlateLineExtensionK101421 DeviceDescription TheBiometProximalHumeralPlati… | 2006 |
| * | K101421 | Medical Plates, Lateral Plates, Posterior Lateral Plates, Olecranon Plates Model…Summary page 4…lenceisclaimed: x ACEProximalHumerusPlatesK955472 x S3ShoulderPlatingSystemK060290 x AnatomicLockedPlatingSystemLongPlateLineExtensionK101421 DeviceDescription TheBiometProximalHumeralPlatingSystemofferstwoplatingfamilies(LowandHigh)with bothleftand… | 2010 |
What descends from it? (17)
See all 173 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 14, 2020 | Class II | Z-2315-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2316-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2309-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2318-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2312-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2314-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2306-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2317-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2324-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2307-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2319-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2323-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2305-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2313-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2320-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2321-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2322-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
| May 14, 2020 | Class II | Z-2311-2020 | Device Design | Distributed to the field without having completed design history files or design transfer activities |
The 5 latest of 18 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 10 months on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K163361 (Globus Medical, Inc., 2017) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K955472.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Biomet Proximal Humerus Plating System is indicated for fixation of fractures and fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143697 · printed Nov 5, 2026
Cite this page
510(k) Report. “K143697: Biomet Proximal Humerus Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K143697
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