Biomet, Inc.: FDA filings under this applicant name
FDA lists 445 510(k) clearances under the applicant name “Biomet, Inc.” (first 1978, latest 2026), plus 1 PMA decision, across 91 product codes in 12 review panels. Median 510(k) review time under this name: 85 days. Since 2017 the median was 96 days, against 119 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Zimmer Biomet, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 64 |
| 2013 | 9 | 106 |
| 2014 | 16 | 80 |
| 2015 | 9 | 70 |
| 2016 | 7 | 135 |
| 2017 | 5 | 109 |
| 2018 | 4 | 68 |
| 2019 | 3 | 33 |
| 2020 | 8 | 90 |
| 2021 | 2 | 76 |
| 2022 | 4 | 146 |
| 2023 | 0 | — |
| 2024 | 1 | 40 |
| 2025 | 0 | — |
| 2026 | 2 | 332 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biomet, Inc. took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 119 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 51 | 51 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 44 | 44 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 40 | 40 |
| HWC | Screw, Fixation, Bone | 24 | 24 |
| HRS | Plate, Fixation, Bone | 21 | 21 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 21 | 21 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 11 | 11 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 11 | 11 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 10 | 10 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 10 | 10 |
Plus 81 more product codes.
Review panels
- Orthopedic (392)
- Dental (14)
- General Hospital (10)
- Neurology (8)
- Physical Medicine (8)
- General and Plastic Surgery (5)
- Clinical Chemistry (2)
- Cardiovascular (2)
- Ear, Nose and Throat (1)
- Gastroenterology and Urology (1)
- Ophthalmic (1)
- Radiology (1)
Most recent Biomet, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253434 | OSSTM Orthopedic Salvage System | JDI | 2026-07-01 | 273 |
| K251270 | Taperloc® Complete Hip Stem | LPH | 2026-05-19 | 390 |
| K241014 | Biomet Kirschner Wires (K-Wires) | HTY | 2024-05-22 | 40 |
| K222760 | StageOne Select Hip Cement Spacer Molds | MBB | 2022-12-28 | 106 |
| K221968 | StageOne Shoulder Cement Spacer Molds | MBB | 2022-09-15 | 72 |
| K213287 | StageOne Knee Cement Spacer Molds | MBB | 2022-09-02 | 336 |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve | JDG | 2022-02-07 | 187 |
| K212435 | Comprehensive Humeral Fracture Positioning Sleeves | KWS | 2021-12-10 | 128 |
| K210192 | A.L.P.S. Clavicle Plating System | HRS | 2021-02-19 | 25 |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws | MBI | 2020-11-10 | 355 |
435 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P050009 | PMA | C2 A-TAPER ACETABULAR SYSTEM | 2005-12-16 |
Recalls
547 product recalls in 167 recall events; 48 initiated in the last five years. Most recent: 2026-07-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Biomet, Inc. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via MEB)
- A4648 — Tissue marker, implantable, any type, each (via NEU)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via MEB)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Biomet Manufacturing Corp (128 510(k)s)
- Biomet Orthopedics, Inc. (41 510(k)s)
- Biomet 3i, Inc. (32 510(k)s)
- Biomet Microfixation (30 510(k)s)
- Biomet Spine (23 510(k)s)
- Biomet Spine (Aka Ebi, LLC) (13 510(k)s)
- Biomet Sports Medicine (13 510(k)s)
- Biomet Trauma (7 510(k)s)
- Biomet Micofixation (3 510(k)s)
- Biomet Trauma (Aka Ebi, Lp) (3 510(k)s)
- Biomet UK, Ltd. (3 510(k)s)
- Biomet Manufactuting Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biomet, Inc.?
FDA lists 445 510(k) clearances under the applicant name “Biomet, Inc.” (first 1978, latest 2026), plus 1 PMA decision, across 91 product codes in 12 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biomet, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomet, Inc. is 85 days. Since 2017: 96 days, versus 119 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biomet, Inc.?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 51); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 44); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 40).
Next steps
- See all 445 Biomet, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Biomet, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.