Company · US
Biomet Manufacturing Corp
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2023. Name variants (Inc, Corp, punctuation) are merged.
128510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| PHX | Shoulder Prosthesis, Reverse Configuration | 15 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 14 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 12 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 7 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 6 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 6 |
| HRS | Plate, Fixation, Bone | 5 |
| HWC | Screw, Fixation, Bone | 5 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 5 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 4 |
| JDR | Staple, Fixation, Bone | 4 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 3 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 |
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | 2 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 2 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 2 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 2 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 25, 2023 | K230540 | Patient Specific Planning Solution 3D Bone Models Biomet Manufacturing Corp | LLZ |
| Mar 15, 2023 | K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System Biomet Manufacturing Corp | PHX |
| Nov 4, 2021 | K211729 | Comprehensive® Convertible Glenoid - Vivacit-E Liner Biomet Manufacturing Corp | PHX |
| Feb 19, 2021 | K202232 | Comprehensive Vault Reconstruction System Biomet Manufacturing Corp | PHX |
| Oct 28, 2020 | K193038 | Comprehensive Shoulder System Biomet Manufacturing Corp | MBF |
| Apr 22, 2019 | K182516 | Comprehensive Nano Stemless Shoulder Biomet Manufacturing Corp | PKC |
| Sep 24, 2018 | K181611 | Comprehensive Reverse Shoulder System Biomet Manufacturing Corp | PHX |
| Feb 8, 2018 | K173411 | Comprehensive Segmental Revision System (SRS) Biomet Manufacturing Corp | PHX |
| Jan 3, 2018 | K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate Biomet Manufacturing Corp | PHX |
| Feb 17, 2017 | K163651 | ExpressBraid Graft Manipulation Biomet Manufacturing Corp | GAT |
| May 16, 2016 | K152754 | COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS) Biomet Manufacturing Corp | PHX |
| Apr 21, 2016 | K153558 | Ventix Suture Anchor Biomet Manufacturing Corp | MBI |
| Mar 8, 2016 | K152262 | Ventix Knotless Anchors Biomet Manufacturing Corp | MBI |
| Feb 8, 2016 | K152868 | ExpressBraid Graft Manipulation Biomet Manufacturing Corp | GAT |
| Feb 3, 2016 | K153398 | Comprehensive SRS/Nexel Elbow Biomet Manufacturing Corp | JDC |
| Oct 2, 2015 | K151615 | TiTHON Staple with OsseoTi Technology Biomet Manufacturing Corp | JDR |
| Sep 4, 2015 | K150768 | JuggerKnot Soft Anchors Biomet Manufacturing Corp | MBI |
| Jun 25, 2015 | K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial Biomet Manufacturing, LLC | JDI |
| May 15, 2015 | K150424 | JuggerStitch Meniscal Repair Device Biomet Manufacturing Corp | MBI |
| Mar 30, 2015 | K143697 | Biomet Proximal Humerus Plating System Biomet Manufacturing | HRS |
| Jan 20, 2015 | K143037 | SnapShot Fixation System Biomet Manufacturing Corp | JDR |
| Dec 30, 2014 | K143188 | 3.Omm Biomet Cannulated Screw System Biomet Manufacturing Corp | HWC |
| Nov 19, 2014 | K141263 | TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS Biomet Manufacturing Corp | JDR |
| Nov 13, 2014 | K142658 | Biomet Headless Compression and Twist-off Screws Biomet Manufacturing Corp | HWC |
| Sep 10, 2014 | K140390 | TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS Biomet Manufacturing Corp | MBF |
| Jul 18, 2014 | K141219 | JUGGERLOC BONE TO BONE IMPLANTS/ BONE INSTRUMENTS/ BONE IMPLANT AND INSTRUMENT KITS Biomet Manufacturing Corp | HTN |
| Jul 3, 2014 | K140652 | POROUS COATED COMPREHENSIVE FRACTURE STEMS Biomet Manufacturing Corp | PHX |
| May 28, 2014 | K140509 | BIOMET SIDE ACCESS DISTAL FEMORAL EXPANDABLE Biomet Manufacturing, LLC | KRO |
| Jan 22, 2014 | K131135 | BIOMET STAGE ONE DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY HEMI-SHOULDER PROSTHESIS Biomet Manufacturing Corp | MBB |
| Nov 19, 2013 | K132898 | A.L.P.S. CALCANEAL PLATING SYSTEM Biomet Manufacturing Corp | HRS |
| Oct 9, 2013 | K130390 | COMPREHENSIVE CONVERTIBLE GLENOID Biomet Manufacturing, Inc. | PHX |
| Oct 8, 2013 | K131353 | COMPREHENSIVE REVERSE SHOULDER - TITANIUM GLENOSPHERE Biomet Manufacturing Corp | PHX |
| Sep 6, 2013 | K132239 | COMPREHENSIVE REVERSE SHOULDER SCREWS Biomet Manufacturing Corp | PHX |
| Sep 3, 2013 | K123907 | PRELUDE PF FEMORAL COMPONENTS (MIM COCRMO), PRELUDE PF FEMORAL COMPONENTS (CAST COCRMO), PRELUDE PF PATELLA COMPONENTS, Biomet Manufacturing Corp | KRR |
| Aug 1, 2013 | K130033 | TOGGLELOC XTENDER; TOGGLELOC XL; IMPLANT KIT TOGGLELOC; IMPLANT KIT TOGGLELOC BTB, EXTENDED TOGGLELOC; TOGGLELOC; BTB TO Biomet Manufacturing Corp | MBI |
| Mar 28, 2013 | K122770 | BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831 Biomet Manufacturing Corp | HRS |
| Mar 20, 2013 | K122160 | VANGUARD XP KNEE SYSTEM Biomet Manufacturing Corp | MBH |
| Nov 23, 2012 | K121874 | G7 ACETABULAR SYSTEM Biomet Manufacturing Corp | PBI |
| Oct 22, 2012 | K122277 | OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) IXFORD PARTIAL KNEE REPLACEMENT SYSTEM Biomet Manufacturing Corp | HRY |
| Aug 17, 2012 | K120030 | TAPERLOC COMPLETE SIZE 4MM AND XR 123 Biomet Manufacturing Corp | LPH |
| May 18, 2012 | K113271 | METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONS Biomet Manufacturing, Inc. | KWA |
| May 16, 2012 | K121149 | VANGUARD SSK 360 REVISION KNEE SYSTEM Biomet Manufacturing Corp | JWH |
| Feb 29, 2012 | K113550 | VANGUARD COMPLETE KNEE SYSTEM Biomet Manufacturing Corp | JWH |
| Jan 11, 2012 | K113069 | COMPREHENSIVE REVERSE SHOULDER HUMERAL TRAY Biomet Manufacturing Corp | PHX |
| Dec 16, 2011 | K113121 | COMPREHENSIVE REVERSE SHOULDER Biomet Manufacturing, Inc. | PHX |
| Sep 30, 2011 | K110400 | TAPERLOC COMPLETE MICROPLASTY STEM Biomet Manufacturing Corp | KWA |
| Jul 22, 2011 | K110271 | MAESTRO WRIST PLATING SYSTEM Biomet Manufacturing Corp | HRS |
| Jul 21, 2011 | K110320 | COMPREHENSIVEPROXIMAL HUMERAL PLATING SYSTEM Biomet Manufacturing Corp | HRS |
| Mar 24, 2011 | K110555 | ARCOMXL ACTIVE ARTICULATION Biomet Manufacturing Corp | LPH |
| Mar 3, 2011 | K102580 | VANGUARD REMOVABLE MOLDED POLY TIBIA Biomet Manufacturing Corp | JWH |
Newest 50 of 128.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||