Biomet Orthopedics, Inc.: FDA clearances and approvals
Biomet Orthopedics, Inc. has 41 FDA 510(k) clearances (first 2000, latest 2026), across 20 product codes in 1 review panel. Median 510(k) review time: 78 days. Since 2017 its median was 258 days, against 107 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 2 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 234 |
| 2013 | 1 | 162 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 316 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 219 |
| 2024 | 0 | — |
| 2025 | 1 | 75 |
| 2026 | 2 | 274 |
Review time against the same product codes
Since 2017, Biomet Orthopedics, Inc.'s cleared 510(k)s took a median 258 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 107 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 4 | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 4 | 4 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 4 | 4 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 | 3 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 3 | 3 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 2 | 2 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 2 | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 | 2 |
Plus 10 more product codes.
Review panels
- Orthopedic (41)
Most recent Biomet Orthopedics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments | JDI | 2026-08-24 | 290 |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | PHX | 2026-04-15 | 258 |
| K243761 | A.L.P.S. Small Fragment Plating System | HRS | 2025-02-19 | 75 |
| K223631 | Comprehensive Segmental Revision System(SRS) | KWT | 2023-07-12 | 219 |
| K200196 | Taperloc® Complete Hip Stems | LZO | 2020-12-08 | 316 |
| K131393 | MAK OSS FEMORAL KNEE COMPONENTS | KRO | 2013-10-24 | 162 |
| K112905 | COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM | MBF | 2012-05-24 | 234 |
| K080528 | E-POLY TIBIAL BEARINGS | JWH | 2008-06-17 | 112 |
| K072879 | INNERVUE DIAGNOSTIC SCOPE SYSTEM | HRX | 2008-01-14 | 97 |
| K070955 | ACID ETCHED LAG SCREWS | HSB | 2007-10-12 | 190 |
31 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Biomet Orthopedics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Biomet Orthopedics, Inc. is the industry lead sponsor of 2 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00578851: A Clinical Investigation of the C2a-Taper™ Acetabular System (Completed, started 2006-04)
- NCT00578994: A Clinical Investigation of the Oxford® Meniscal Unicompartmental Knee System (Completed, started 2006-03)
Frequently asked questions
How many FDA 510(k) clearances does Biomet Orthopedics, Inc. have?
Biomet Orthopedics, Inc. has 41 FDA 510(k) clearances (first 2000, latest 2026), across 20 product codes in 1 review panel.
How long does FDA take to clear Biomet Orthopedics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Biomet Orthopedics, Inc.'s cleared 510(k)s is 78 days. Since 2017: 258 days, versus 107 days for all cleared 510(k)s in the same product codes.
What devices does Biomet Orthopedics, Inc. make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 4); HSB (Rod, Fixation, Intramedullary And Accessories, 4); HWC (Screw, Fixation, Bone, 4).
Has Biomet Orthopedics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Biomet Orthopedics, Inc. Related entities may recall under other names.
Next steps
- See all 41 Biomet Orthopedics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Biomet Orthopedics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.