Biomet Trauma: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Biomet Trauma” (first 2007, latest 2009), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
Review panels
- Orthopedic (7)
Most recent Biomet Trauma 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091976 | BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL | HSB | 2009-08-17 | 47 |
| K092078 | OPTILOCK PERIARTICULAR PLATING | HRS | 2009-08-05 | 27 |
| K082874 | BIODRIVE CANNULATED SCREW SYSTEM | HWC | 2009-02-05 | 129 |
| K081244 | LOWER EXTREMITY EXTERNAL FIXATION - EXPANDED INDICATIONS | KTT | 2008-07-30 | 90 |
| K081243 | BIOMET PHOENIX ANKLE NAIL SYSTEM | HSB | 2008-06-27 | 57 |
| K071325 | BIOMET VARIABLE LOCKING PLATE SYSTEM | HRS | 2007-07-26 | 77 |
| K070823 | GROWTH CONTROL PLATING SYSTEM | HRS | 2007-05-07 | 42 |
Recalls
openFDA lists no recalls under a recalling firm named Biomet Trauma.
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 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 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 Trauma?
FDA lists 7 510(k) clearances under the applicant name “Biomet Trauma” (first 2007, latest 2009), across 4 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biomet Trauma?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biomet Trauma is 57 days.
Which FDA product codes appear under Biomet Trauma?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 3); HSB (Rod, Fixation, Intramedullary And Accessories, 2); HWC (Screw, Fixation, Bone, 1).
Next steps
- See all 7 Biomet Trauma clearances with predicates and recalls
- Run predicate analysis for product code HRS, Biomet Trauma'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.