Biomet Microfixation: FDA clearances and approvals
Biomet Microfixation has 30 FDA 510(k) clearances (first 2007, latest 2026), plus 1 PMA decision, across 8 product codes in 4 review panels. Median 510(k) review time: 104 days. Since 2017 its median was 98 days, against 103 days for all cleared 510(k)s in the same product codes. openFDA lists 62 product recalls by a recalling firm named Biomet Microfixation.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 4 | 137 |
| 2013 | 3 | 62 |
| 2014 | 0 | — |
| 2015 | 5 | 132 |
| 2016 | 4 | 36 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 91 |
| 2020 | 0 | — |
| 2021 | 2 | 197 |
| 2022 | 4 | 178 |
| 2023 | 0 | — |
| 2024 | 1 | 98 |
| 2025 | 0 | — |
| 2026 | 1 | 68 |
Review time against the same product codes
Since 2017, Biomet Microfixation's cleared 510(k)s took a median 98 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 103 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 15 | 15 |
| JEY | Plate, Bone | 8 | 8 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 2 | 2 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| GXR | Cover, Burr Hole | 1 | 1 |
| LZD | Joint, Temporomandibular, Implant | 1 | 0 |
| OCV | Endoscope Holder | 1 | 1 |
Review panels
- Orthopedic (17)
- Dental (9)
- Neurology (4)
- Gastroenterology and Urology (1)
Most recent Biomet Microfixation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261002 | Pectus Blu System | HRS | 2026-06-02 | 68 |
| K241709 | Pectus Blu Support Bar System | HRS | 2024-09-19 | 98 |
| K223199 | 2.1 x 255mm Drill, 22mm Stop | HBE | 2022-11-15 | 33 |
| K212782 | SternaLock Sternal Closure System | HRS | 2022-05-17 | 258 |
| K212608 | RibFix Blu Thoracic Fixation System | HRS | 2022-04-22 | 248 |
| K213712 | Pectus Support Bar System | HRS | 2022-03-11 | 107 |
| K213208 | Twist Drills | HBE | 2021-12-23 | 85 |
| K202969 | Biomet Microfixation OmniMax MMF System | JEY | 2021-08-05 | 309 |
| K190576 | WalterLorenz Surgical Assist Arm Scope Holder | OCV | 2019-06-05 | 91 |
| K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | HRS | 2016-12-09 | 45 |
20 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P020016 | PMA | WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM | 2005-09-21 |
Recalls
62 product recalls in 35 recall events; 0 initiated in the last five years. Most recent: 2017-04-11.
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.
Frequently asked questions
How many FDA 510(k) clearances does Biomet Microfixation have?
Biomet Microfixation has 30 FDA 510(k) clearances (first 2007, latest 2026), plus 1 PMA decision, across 8 product codes in 4 review panels.
How long does FDA take to clear Biomet Microfixation's 510(k)s?
The median time from FDA receipt to decision across Biomet Microfixation's cleared 510(k)s is 104 days. Since 2017: 98 days, versus 103 days for all cleared 510(k)s in the same product codes.
What devices does Biomet Microfixation make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 15); JEY (Plate, Bone, 8); HBE (Drills, Burrs, Trephines & Accessories (Simple, Powered), 2).
Has Biomet Microfixation had device recalls?
openFDA lists 62 product recalls in 35 recall events by a recalling firm whose name matches Biomet Microfixation; the most recent began 2017-04-11. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 30 Biomet Microfixation clearances with predicates and recalls
- Run predicate analysis for product code HRS, Biomet Microfixation'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.