Biomet Manufacturing Corp: FDA filings under this applicant name
FDA lists 128 510(k) clearances under the applicant name “Biomet Manufacturing Corp” (first 1999, latest 2023), plus 1 PMA decision, across 42 product codes in 5 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 150 days, against 107 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 | 7 | 90 |
| 2013 | 8 | 204 |
| 2014 | 8 | 100 |
| 2015 | 6 | 102 |
| 2016 | 5 | 131 |
| 2017 | 1 | 56 |
| 2018 | 3 | 99 |
| 2019 | 1 | 221 |
| 2020 | 1 | 363 |
| 2021 | 2 | 174 |
| 2022 | 0 | — |
| 2023 | 2 | 298 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biomet Manufacturing Corp took a median 150 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 |
|---|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 15 | 15 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 14 | 14 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 12 | 12 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 7 | 7 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 6 | 6 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 6 | 6 |
| HRS | Plate, Fixation, Bone | 5 | 5 |
| HWC | Screw, Fixation, Bone | 5 | 5 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 5 | 5 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 4 | 4 |
Plus 32 more product codes.
Review panels
- Orthopedic (123)
- General and Plastic Surgery (3)
- Clinical Chemistry (1)
- Neurology (1)
- Radiology (1)
Most recent Biomet Manufacturing Corp 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230540 | Patient Specific Planning Solution 3D Bone Models | LLZ | 2023-07-25 | 148 |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System | PHX | 2023-03-15 | 449 |
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E Liner | PHX | 2021-11-04 | 153 |
| K202232 | Comprehensive Vault Reconstruction System | PHX | 2021-02-19 | 196 |
| K193038 | Comprehensive Shoulder System | MBF | 2020-10-28 | 363 |
| K182516 | Comprehensive Nano Stemless Shoulder | PKC | 2019-04-22 | 221 |
| K181611 | Comprehensive Reverse Shoulder System | PHX | 2018-09-24 | 97 |
| K173411 | Comprehensive Segmental Revision System (SRS) | PHX | 2018-02-08 | 99 |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate | PHX | 2018-01-03 | 138 |
| K163651 | ExpressBraid Graft Manipulation | GAT | 2017-02-17 | 56 |
118 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P010014 | PMA | OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM | 2004-04-21 |
Recalls
openFDA lists no recalls under a recalling firm named Biomet Manufacturing Corp.
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.
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, Inc. (445 510(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 Manufacturing Corp?
FDA lists 128 510(k) clearances under the applicant name “Biomet Manufacturing Corp” (first 1999, latest 2023), plus 1 PMA decision, across 42 product codes in 5 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 Manufacturing Corp?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomet Manufacturing Corp is 90 days. Since 2017: 150 days, versus 107 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biomet Manufacturing Corp?
The most frequent FDA product codes under this applicant name are PHX (Shoulder Prosthesis, Reverse Configuration, 15); KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), 14); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 12).
Next steps
- See all 128 Biomet Manufacturing Corp clearances with predicates and recalls
- Run predicate analysis for product code PHX, Biomet Manufacturing Corp'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.