Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomet Microfixation — Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
113 daysmedian FDA review time
248 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261002 | Pectus Blu System | Biomet Microfixation | 2026-06-02 | 68 | 0 |
| K241709 | Pectus Blu Support Bar System | Biomet Microfixation | 2024-09-19 | 98 | 0 |
| K223199 | 2.1 x 255mm Drill, 22mm Stop | Biomet Microfixation | 2022-11-15 | 33 | 0 |
| K212782 | SternaLock Sternal Closure System | Biomet Microfixation | 2022-05-17 | 258 | 0 |
| K212608 | RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2022-04-22 | 248 | 0 |
| K213712 | Pectus Support Bar System | Biomet Microfixation | 2022-03-11 | 107 | 0 |
| K213208 | Twist Drills | Biomet Microfixation | 2021-12-23 | 85 | 0 |
| K202969 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2021-08-05 | 309 | 0 |
| K190576 | WalterLorenz Surgical Assist Arm Scope Holder | Biomet Microfixation | 2019-06-05 | 91 | 0 |
| K162974 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2016-12-09 | 45 | 0 |
| K163007 | Biomet Microfixation SternaLock 360 Sternal Closure System | Biomet Microfixation | 2016-11-23 | 26 | 0 |
| K161896 | Biomet Microfixation Sternal Closure System | Biomet Microfixation | 2016-08-02 | 22 | 0 |
| K152253 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2016-03-24 | 227 | 0 |
| K152326 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015-12-10 | 114 | 0 |
| K151019 | SternaLockĀ® 360 Sternal Closure System | Biomet Microfixation | 2015-11-03 | 201 | 0 |
| K151173 | Biomet Microfixation RibFix Blu Thoracic Fixation System | Biomet Microfixation | 2015-05-26 | 25 | 0 |
| K143336 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | 2015-04-01 | 132 | 0 |
| K142823 | Biomet Microfixation Thoracic Fixation System | Biomet Microfixation | 2015-02-25 | 148 | 0 |
| K132600 | FACIAL PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | Biomet Microfixation | 2013-10-02 | 43 | 0 |
| K131674 | PREBENT PLATING WITH VIRTUAL SURGICAL PLANNING | Biomet Microfixation | 2013-08-08 | 62 | 0 |
| K130309 | RAPIDFLAP LS CRANIAL FLAP FIXATION SYSTEM | Biomet Microfixation | 2013-06-17 | 130 | 0 |
| K121624 | BIOMET MICROFIXATION NEURO PLATING SYSTEM | Biomet Microfixation | 2012-10-12 | 133 | 0 |
| K121589 | BIOMET MICROFIXATION FACIAL PLATING SYSTEM | Biomet Microfixation | 2012-09-21 | 113 | 0 |
| K121302 | BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM | Biomet Microfixation | 2012-09-19 | 141 | 0 |
| K113512 | BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEV | Biomet Microfixation | 2012-06-29 | 214 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda