Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomet Manufacturing, Inc. · Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
199 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130390 | COMPREHENSIVE CONVERTIBLE GLENOID | Biomet Manufacturing, Inc. | 2013-10-09 | 236 | 1 |
| K113271 | METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS | Biomet Manufacturing, Inc. | 2012-05-18 | 196 | 0 |
| K113121 | COMPREHENSIVE REVERSE SHOULDER | Biomet Manufacturing, Inc. | 2011-12-16 | 56 | 0 |
| K080685 | HIPLOC COMPRESSION HIP SCREW | Biomet Manufacturing, Inc. | 2008-08-15 | 157 | 0 |
| K080088 | BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS | Biomet Manufacturing, Inc. | 2008-06-11 | 149 | 8 |
| K071271 | BIOMET CABLE SYSTEM | Biomet Manufacturing, Inc. | 2007-10-23 | 169 | 0 |
| K070399 | 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES | Biomet Manufacturing, Inc. | 2007-05-04 | 81 | 0 |
| K063515 | TITANIUM REPICCI II UNICONDYLAR FEMORAL KNEE COMPONENTS COCR | Biomet Manufacturing, Inc. | 2007-02-02 | 73 | 0 |
| K061340 | 23 MM SINGLE-PEG PATELLA COMPONENT | Biomet Manufacturing, Inc. | 2006-09-25 | 133 | 0 |
| K061433 | VANGUARD ANATOMIC PATELLA GROOVE (APG) / VANGUARD V GROOVE | Biomet Manufacturing, Inc. | 2006-08-21 | 89 | 0 |
| K053505 | REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUG | Biomet Manufacturing, Inc. | 2006-08-14 | 241 | 0 |
| K052639 | GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL C | Biomet Manufacturing, Inc. | 2006-05-03 | 219 | 0 |
| K052089 | XR-SERIES BI-METRIC FEMORAL COMPONENTS | Biomet Manufacturing, Inc. | 2006-02-17 | 199 | 0 |
| K053299 | REPICCI II ONLAY UNICOMPARTMENTAL TIBIAL COMPONENT | Biomet Manufacturing, Inc. | 2006-01-05 | 41 | 0 |
| K051479 | RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL | Biomet Manufacturing, Inc. | 2005-08-10 | 68 | 0 |
| K050028 | MAESTRO CARPAL HEMIARTHROPLASTY | Biomet Manufacturing, Inc. | 2005-03-25 | 78 | 0 |
| K041850 | MEDALLION MODULAR HIP SYSTEM | Biomet Manufacturing, Inc. | 2004-12-21 | 166 | 0 |
| K041089 | OSS BONE GRAFT SYSTEM AND OSS RAPIDSET BONE GRAFT SYSTEM | Biomet Manufacturing, Inc. | 2004-08-31 | 127 | 0 |
| K040610 | VERSA-DIAL HUMERAL HEAD | Biomet Manufacturing, Inc. | 2004-06-04 | 88 | 0 |
| K040770 | VANGUARD PATELLA COMPONENTS | Biomet Manufacturing, Inc. | 2004-04-22 | 28 | 11 |
| K033838 | TITANIUM TOGGLE BUTTON(S) | Biomet Manufacturing, Inc. | 2004-02-13 | 65 | 1 |
| K020962 | G4 SLEEVED NAIL | Biomet Manufacturing, Inc. | 2002-05-24 | 60 | 0 |
| K012469 | RESORBABLE NO PROFILE SCREW AND WASHER | Biomet Manufacturing, Inc. | 2001-12-03 | 123 | 0 |
| K012503 | METAL SCREW ANCHOR | Biomet Manufacturing, Inc. | 2001-10-22 | 80 | 0 |
| K010657 | COPELAND MB RESURFACING HUMERAL HEADS | Biomet Manufacturing, Inc. | 2001-09-14 | 192 | 0 |
| K010664 | COPELAND RESURFACING HUMERAL HEADS | Biomet Manufacturing, Inc. | 2001-04-05 | 30 | 0 |
| K002020 | LACTOSORB MENISCAL SCREW | Biomet Manufacturing, Inc. | 2000-08-25 | 53 | 0 |
| K001374 | PATIENT MATCHED COBALT ALLOY TROCHLEA REPLACEMENT | Biomet Manufacturing, Inc. | 2000-07-27 | 87 | 0 |
| K000262 | BOHN FEMORAL COMPONENT | Biomet Manufacturing, Inc. | 2000-04-03 | 66 | 0 |
| K994326 | ASCENT KNEE SYSTEM | Biomet Manufacturing, Inc. | 2000-01-07 | 16 | 0 |
| K993111 | ASCENT KNEE SYSTEM | Biomet Manufacturing, Inc. | 1999-10-05 | 18 | 0 |
| K992301 | REUNITE SCREWS | Biomet Manufacturing, Inc. | 1999-09-01 | 55 | 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