Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biomet Manufacturing Corp · Predicate Candidate Screening
93 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
247 days90th percentile
93clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230540 | Patient Specific Planning Solution™ 3D Bone Models | Biomet Manufacturing Corp | 2023-07-25 | 148 | 0 |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoul | Biomet Manufacturing Corp | 2023-03-15 | 449 | 0 |
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E Liner | Biomet Manufacturing Corp | 2021-11-04 | 153 | 0 |
| K202232 | Comprehensive Vault Reconstruction System | Biomet Manufacturing Corp | 2021-02-19 | 196 | 0 |
| K193038 | Comprehensive Shoulder System | Biomet Manufacturing Corp | 2020-10-28 | 363 | 1 |
| K182516 | Comprehensive Nano Stemless Shoulder | Biomet Manufacturing Corp | 2019-04-22 | 221 | 0 |
| K181611 | Comprehensive Reverse Shoulder System | Biomet Manufacturing Corp | 2018-09-24 | 97 | 0 |
| K173411 | Comprehensive Segmental Revision System (SRS) | Biomet Manufacturing Corp | 2018-02-08 | 99 | 0 |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive St | Biomet Manufacturing Corp | 2018-01-03 | 138 | 0 |
| K163651 | ExpressBraid Graft Manipulation | Biomet Manufacturing Corp | 2017-02-17 | 56 | 0 |
| K152754 | COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) | Biomet Manufacturing Corp | 2016-05-16 | 235 | 0 |
| K153558 | Ventix Suture Anchor | Biomet Manufacturing Corp | 2016-04-21 | 129 | 0 |
| K152262 | Ventix Knotless Anchors | Biomet Manufacturing Corp | 2016-03-08 | 210 | 0 |
| K152868 | ExpressBraid Graft Manipulation | Biomet Manufacturing Corp | 2016-02-08 | 131 | 0 |
| K153398 | Comprehensive SRS/Nexel Elbow | Biomet Manufacturing Corp | 2016-02-03 | 71 | 0 |
| K151615 | TiTHON Staple with OsseoTi Technology | Biomet Manufacturing Corp | 2015-10-02 | 109 | 0 |
| K150768 | JuggerKnot Soft Anchors | Biomet Manufacturing Corp | 2015-09-04 | 164 | 0 |
| K150424 | JuggerStitch Meniscal Repair Device | Biomet Manufacturing Corp | 2015-05-15 | 85 | 0 |
| K143037 | SnapShot Fixation System | Biomet Manufacturing Corp | 2015-01-20 | 90 | 0 |
| K143188 | 3.Omm Biomet Cannulated Screw System | Biomet Manufacturing Corp | 2014-12-30 | 55 | 1 |
| K141263 | TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS | Biomet Manufacturing Corp | 2014-11-19 | 188 | 1 |
| K142658 | Biomet Headless Compression and Twist-off Screws | Biomet Manufacturing Corp | 2014-11-13 | 56 | 0 |
| K140390 | TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS | Biomet Manufacturing Corp | 2014-09-10 | 208 | 0 |
| K141219 | JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPL | Biomet Manufacturing Corp | 2014-07-18 | 67 | 0 |
| K140652 | POROUS COATED COMPREHENSIVE FRACTURE STEMS | Biomet Manufacturing Corp | 2014-07-03 | 111 | 0 |
| K131135 | BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORAR | Biomet Manufacturing Corp | 2014-01-22 | 275 | 5 |
| K132898 | A.L.P.S. CALCANEAL PLATING SYSTEM | Biomet Manufacturing Corp | 2013-11-19 | 64 | 0 |
| K131353 | COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE | Biomet Manufacturing Corp | 2013-10-08 | 151 | 0 |
| K132239 | COMPREHENSIVE REVERSE SHOULDER SCREWS | Biomet Manufacturing Corp | 2013-09-06 | 50 | 1 |
| K123907 | PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMOR | Biomet Manufacturing Corp | 2013-09-03 | 258 | 1 |
| K130033 | TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPL | Biomet Manufacturing Corp | 2013-08-01 | 209 | 2 |
| K122770 | BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-8 | Biomet Manufacturing Corp | 2013-03-28 | 199 | 0 |
| K122160 | VANGUARD XP KNEE SYSTEM | Biomet Manufacturing Corp | 2013-03-20 | 243 | 0 |
| K121874 | G7 ACETABULAR SYSTEM | Biomet Manufacturing Corp | 2012-11-23 | 149 | 3 |
| K122277 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFOR | Biomet Manufacturing Corp | 2012-10-22 | 84 | 30 |
| K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 | Biomet Manufacturing Corp | 2012-08-17 | 226 | 0 |
| K121149 | VANGUARD SSK 360 REVISION KNEE SYSTEM | Biomet Manufacturing Corp | 2012-05-16 | 30 | 0 |
| K113550 | VANGUARD COMPLETE KNEE SYSTEM | Biomet Manufacturing Corp | 2012-02-29 | 90 | 4 |
| K113069 | COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY | Biomet Manufacturing Corp | 2012-01-11 | 86 | 0 |
| K110400 | TAPERLOC COMPLETE MICROPLASTY STEM | Biomet Manufacturing Corp | 2011-09-30 | 231 | 0 |
| K110271 | MAESTRO WRIST PLATING SYSTEM | Biomet Manufacturing Corp | 2011-07-22 | 172 | 0 |
| K110320 | COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM | Biomet Manufacturing Corp | 2011-07-21 | 168 | 0 |
| K110555 | ARCOMXL ACTIVE ARTICULATION | Biomet Manufacturing Corp | 2011-03-24 | 24 | 0 |
| K102580 | VANGUARD REMOVABLE MOLDED POLY TIBIA | Biomet Manufacturing Corp | 2011-03-03 | 176 | 0 |
| K110362 | VANGUARD ASYMMETRICAL PATELLAR COMPONENT | Biomet Manufacturing Corp | 2011-02-28 | 20 | 0 |
| K103755 | TAPERLOC COMPLETE, SIZE 5 AND 6 | Biomet Manufacturing Corp | 2011-01-21 | 29 | 0 |
| K101336 | E1 AVANTAGE HEAD | Biomet Manufacturing Corp | 2011-01-14 | 247 | 1 |
| K100469 | ARCOS INTERLOCKING DISTAL STEMS | Biomet Manufacturing Corp | 2010-12-07 | 292 | 0 |
| K093803 | BIO-MODULAR REVERSE SHOLDER | Biomet Manufacturing Corp | 2010-10-19 | 312 | 0 |
| K101475 | COMPRESS ANTI-ROTATION SPINDLES | Biomet Manufacturing Corp | 2010-06-18 | 21 | 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