Biomet Manufacturing Corp
Medical device manufacturer in Warsaw, IN.
128510(k) clearances
1PMA approvals
0recalls
Device types
- PHX Shoulder Prosthesis, Reverse Configuration 15
- KWA Prosthesis, Hip, Semi-Constrained (Metal… 14
- JWH Prosthesis, Knee, Patellofemorotibial… 12
- MBI Fastener, Fixation, Nondegradable, Soft… 7
- LPH Prosthesis, Hip, Semi-Constrained… 6
- MBH Prosthesis, Knee, Patello/Femorotibial… 6
- HRS Plate, Fixation, Bone 5
- KRO Prosthesis, Knee, Femorotibial… 5
- HWC Screw, Fixation, Bone 5
- JDR Staple, Fixation, Bone 4
- HRY Prosthesis, Knee, Femorotibial… 4
- MBF Prosthesis, Shoulder, Semi-Constrained… 4
- HSB Rod, Fixation, Intramedullary And Accessories 3
- LZO Prosthesis, Hip, Semi-Constrained… 3
- JDI Prosthesis, Hip, Semi-Constrained… 3
- KWS Prosthesis, Shoulder, Semi-Constrained… 2
- HSD Prosthesis, Shoulder, Hemi-, Humeral… 2
- KRR Prosthesis, Knee, Patello/Femoral… 2
- JDC Prosthesis, Elbow, Constrained, Cemented 2
- LOD Bone Cement 2
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K230540 | Patient Specific Planning Solution 3D Bone ModelsLLZ · Traditional | 07/25/2023SE |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder SystemPHX · Traditional | 03/15/2023SE |
| K211729 | Comprehensive® Convertible Glenoid - Vivacit-E LinerPHX · Traditional | 11/04/2021SE |
| K202232 | Comprehensive Vault Reconstruction SystemPHX · Traditional | 02/19/2021SE |
| K193038 | Comprehensive Shoulder SystemMBF · Traditional | 10/28/2020SE |
| K182516 | Comprehensive Nano Stemless ShoulderPKC · Traditional | 04/22/2019SE |
| K181611 | Comprehensive Reverse Shoulder SystemPHX · Traditional | 09/24/2018SE |
| K173411 | Comprehensive Segmental Revision System (SRS)PHX · Traditional | 02/08/2018SE |
| K172502 | Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…PHX · Traditional | 01/03/2018SE |
| K163651 | ExpressBraid Graft ManipulationGAT · Traditional | 02/17/2017SE |
| K152754 | Comprehensive Vault Reconstruction System (VRS)PHX · Traditional | 05/16/2016SE |
| K153558 | Ventix Suture AnchorMBI · Traditional | 04/21/2016SE |
| K152262 | Ventix Knotless AnchorsMBI · Traditional | 03/08/2016SE |
| K152868 | ExpressBraid Graft ManipulationGAT · Traditional | 02/08/2016SE |
| K153398 | Comprehensive SRS/Nexel ElbowJDC · Traditional | 02/03/2016SE |
| K151615 | TiTHON Staple with OsseoTi TechnologyJDR · Traditional | 10/02/2015SE |
| K150768 | JuggerKnot Soft AnchorsMBI · Traditional | 09/04/2015SE |
| K142814 | Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid TibialJDI · Traditional | 06/25/2015SE |
| K150424 | JuggerStitch Meniscal Repair DeviceMBI · Traditional | 05/15/2015SE |
| K143697 | Biomet Proximal Humerus Plating SystemHRS · Traditional | 03/30/2015SE |
| K143037 | SnapShot Fixation SystemJDR · Traditional | 01/20/2015SE |
| K143188 | 3.Omm Biomet Cannulated Screw SystemHWC · Traditional | 12/30/2014SE |
| K141263 | Toggleloc and Juggerloc Implants/Instruments/KitsJDR · Traditional | 11/19/2014SE |
| K142658 | Biomet Headless Compression and Twist-off ScrewsHWC · Traditional | 11/13/2014SE |
| K140390 | Titanium Versa-Dial Humeral Head ProsthesisMBF · Traditional | 09/10/2014SE |
| K141219 | Juggerloc Bone to Bone Implants/ Bone Instruments/ Bone Implant and Instrument KitsHTN · Traditional | 07/18/2014SE |
| K140652 | Porous Coated Comprehensive Fracture StemsPHX · Traditional | 07/03/2014SE |
| K140509 | Biomet Side Access Distal Femoral ExpandableKRO · Traditional | 05/28/2014SE |
| K131135 | Biomet Stage One Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisMBB · Traditional | 01/22/2014SE |
| K132898 | A.L.P.S. Calcaneal Plating SystemHRS · Traditional | 11/19/2013SE |
| K130390 | Comprehensive Convertible GlenoidPHX · Traditional | 10/09/2013SE |
| K131353 | Comprehensive Reverse Shoulder - Titanium GlenospherePHX · Traditional | 10/08/2013SE |
| K132239 | Comprehensive Reverse Shoulder ScrewsPHX · Traditional | 09/06/2013SE |
| K123907 | Prelude PF Femoral Components (Mim Cocrmo), Prelude PF Femoral Components (Cast Cocrmo)…KRR · Traditional | 09/03/2013SE |
| K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…MBI · Traditional | 08/01/2013SE |
| K122770 | Biomet Reconstructive Wedges Model 110003660-99, 110003797-831HRS · Traditional | 03/28/2013SE |
| K122160 | Vanguard XP Knee SystemMBH · Traditional | 03/20/2013SE |
| K121874 | G7 Acetabular SystemPBI · Traditional | 11/23/2012SE |
| K122277 | Oxford Fixed Lateral Bearing Partial Knee Replacement (Oxford Tibial Trays A-F) Ixford…HRY · Traditional | 10/22/2012SE |
| K120030 | Taperloc Complete Size 4MM and XR 123LPH · Traditional | 08/17/2012SE |
| K113271 | Metal-On-Metal Hip Systems-Additional ContraindicationsKWA · Traditional | 05/18/2012SE |
| K121149 | Vanguard SSK 360 Revision Knee SystemJWH · Special | 05/16/2012SE |
| K113550 | Vanguard Complete Knee SystemJWH · Traditional | 02/29/2012SE |
| K113069 | Comprehensive Reverse Shoulder Humeral TrayPHX · Traditional | 01/11/2012SE |
| K113121 | Comprehensive Reverse ShoulderPHX · Special | 12/16/2011SE |
| K110400 | Taperloc Complete Microplasty StemKWA · Traditional | 09/30/2011SE |
| K110271 | Maestro Wrist Plating SystemHRS · Traditional | 07/22/2011SE |
| K110320 | Comprehensiveproximal Humeral Plating SystemHRS · Traditional | 07/21/2011SE |
| K110555 | Arcomxl Active ArticulationLPH · Special | 03/24/2011SE |
| K102580 | Vanguard Removable Molded Poly TibiaJWH · Traditional | 03/03/2011SE |
| K110362 | Vanguard Asymmetrical Patellar ComponentJWH · Traditional | 02/28/2011SE |
| K103755 | Taperloc Complete, Size 5 and 6KWA · Special | 01/21/2011SE |
| K101336 | E1 Avantage HeadLPH · Traditional | 01/14/2011SE |
| K100469 | Arcos Interlocking Distal StemsKWA · Traditional | 12/07/2010SE |
| K093803 | Bio-Modular Reverse SholderPHX · Traditional | 10/19/2010SE |
| K101475 | Compress Anti-Rotation SpindlesKWA · Special | 06/18/2010SE |
| K100048 | E1 Antioxidant Infused TechnologyOIY · Traditional | 03/09/2010SE |
| K093549 | 44MM E1 Acetabular Liner with 44MM Biolox Delta Option Ceramic Head or 44MM M a MagnumLZO · Special | 12/16/2009SE |
| K091608 | Cobalt MV Bone CementLOD · Traditional | 09/17/2009SE |
| K083782 | Regenerex Patella ComponentsMBH · Traditional | 04/03/2009SE |
| K083779 | Mak Oss Knee Femoral ComponentsKRO · Traditional | 04/03/2009SE |
| K090473 | Discovery Elbow - X-SmallJDC · Special | 03/25/2009SE |
| K083827 | Orthopedic Salvage System (Oss) 9CM Cobalt - Chrome Tibial BodiesKRO · Special | 02/13/2009SE |
| K080979 | Stageone Select Cement Spacer Molds for Temporary Hip ReplacementKWY · Traditional | 10/31/2008SE |
| K082826 | Vanguard CR Stem HousingsJWH · Special | 10/24/2008SE |
| K080685 | Hiploc Compression Hip ScrewJDO · Traditional | 08/15/2008SE |
| K080426 | Maestro Wrist Fracture ImplantJWJ · Traditional | 07/29/2008SE |
| K081172 | Composite Hitch Suture AnchorJDR · Traditional | 07/17/2008SE |
| K080088 | Biomet Sports Medicine Anchor Devices and Ziploop ConstructsHWC · Traditional | 06/11/2008SE |
| K073637 | Parallel-Sided Extensively Coated Femoral StemsKWA · Traditional | 03/20/2008SE |
| K072804 | Comprehensive RS Shoulder SystemPHX · Traditional | 12/12/2007SE |
| K070015 | Cobalt V Radiopaque Vertebroplasty Bone CementLOD · Abbreviated | 11/30/2007SE |
| K073102 | Biolox Delta Ceramic Heads with 100KGY E-Poly Acetabular LinersLZO · Special | 11/27/2007SE |
| K072336 | Regenerex Porous Titanium Sleeve AugmentsJWH · Traditional | 11/05/2007SE |
| K071271 | Biomet Cable SystemJDQ · Traditional | 10/23/2007SE |
| K071934 | Marrowstim Concentration Kit and Marrowstim Mini Concentration KitJQC · Traditional | 10/11/2007SE |
| K072161 | Biomet Femoral Locking Nail SystemHSB · Traditional | 09/20/2007SE |
| K071395 | Biomet Vision Footring SystemKTT · Traditional | 07/09/2007SE |
| K062558 | Mesosfol Surgical FilmFTM · Traditional | 06/20/2007SE |
| K070399 | 100KGY E-Poly Acetabular Liners-Additional ProfilesJDI · Special | 05/04/2007SE |
| K070274 | Echo Bi-Metric Press-Fit StemsKWA · Special | 04/03/2007SE |
| K062994 | Lateralized Taperloc Microplasty Femoral ComponentsKWA · Special | 03/09/2007SE |
| K063570 | Biomet Tibial Locking Nail SystemHSB · Traditional | 02/27/2007SE |
| K063614 | Altra FX Hip SystemKWA · Traditional | 02/20/2007SE |
| K063515 | Titanium Repicci II Unicondylar Femoral Knee Components Cocr Repicci II Unicondylar KneeHRY · Traditional | 02/02/2007SE |
| K062998 | Compress Segmental Femoral Replacement System (Short Spindle and Anchor Plug)KWA · Traditional | 01/19/2007SE |
| K063732 | Microplasty Tibial TraysJWH · Traditional | 01/18/2007SE |
| K060694 | Modular Hybrid GlenoidKWS · Traditional | 12/11/2006SE |
| K062997 | Arcomxl Polyethylene Liners and 38/40MM Femoral HeadsLZO · Traditional | 12/08/2006SE |
| K063002 | Altra Press-Fit Hip SystemKWA · Special | 10/31/2006SE |
| K062995 | M2A-MAGNUM Tri-Spike Acetabular ComponentKWA · Special | 10/31/2006SE |
| K061681 | Repicci II Metal Back Inlay Unicompartmental Tibial Bearing ComponentHRY · Traditional | 10/19/2006SE |
| K061340 | 23 MM Single-Peg Patella ComponentJWH · Traditional | 09/25/2006SE |
| K061433 | Vanguard Anatomic Patella Groove (Apg) / Vanguard V GrooveMBH · Traditional | 08/21/2006SE |
| K053505 | Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsMBH · Traditional | 08/14/2006SE |
| K061423 | M2A Magnum 12/14 Taper Inserts and One-Piece Modular HeadsKWA · Traditional | 07/27/2006SE |
| K060716 | Versa-Dial Humeral Head ProsthesisMBF · Traditional | 06/12/2006SE |
| K060692 | Comprehensive Primary Shoulder StemsMBF · Traditional | 05/30/2006SE |
| K060525 | Vanguard Removable Molded Poly TibiaJWH · Traditional | 05/25/2006SE |
| K052639 | Generation 4 Polished Femoral Hip Prosthesis with Proximal Cement SpacerJDI · Traditional | 05/03/2006SE |
| K052996 | Porous Titanium Acetabular ShellsLPH · Traditional | 04/28/2006SE |
| K060303 | Vanguard PS Open Box Porous Femoral ComponentsMBH · Traditional | 03/30/2006SE |
| K060121 | Biomet Pre-Calibrated Computer Aided Surgery Navigation Instruments for Hip ApplicationsHAW · Traditional | 03/21/2006SE |
| K052089 | Xr-Series Bi-Metric Femoral ComponentsLPH · Special | 02/17/2006SE |
| K060131 | Oss-Bodies Proximal Tibial SleeveKRO · Special | 02/15/2006SE |
| K053299 | Repicci II Onlay Unicompartmental Tibial ComponentHRY · Traditional | 01/05/2006SE |
| K052888 | Porous Titanium Acetabular AugmentsKWA · Traditional | 12/06/2005SE |
| K051479 | RS (Reduced Size) Oss (Orthopedic Salvage System) Additional ComponentsKRO · Traditional | 08/10/2005SE |
| K050028 | Maestro Carpal HemiarthroplastyKWN · Traditional | 03/25/2005SE |
| K042321 | Mosaic Non-Modular Proximal Body and Eas Offset Modular Humeral HeadKWT · Traditional | 01/28/2005SE |
| K041850 | Medallion Modular Hip SystemLPH · Traditional | 12/21/2004SE |
| K041872 | Ascent Porous Open Box PS Component/Ascent Posterior Stabalized (PS) Distal Femoral PegsMBH · Traditional | 09/08/2004SE |
| K041089 | Oss Bone Graft System and Oss Rapidset Bone Graft SystemMQV · Traditional | 08/31/2004SE |
| K041466 | Titanium Femoral Knee Components (Maxim and Agc)JWH · Special | 07/01/2004SE |
| K040610 | Versa-Dial Humeral HeadKWS · Traditional | 06/04/2004SE |
| K040770 | Vanguard Patella ComponentsJWH · Special | 04/22/2004SE |
| K033838 | Titanium Toggle Button(S)MBI · Traditional | 02/13/2004SE |
| K020962 | G4 Sleeved NailHSB · Traditional | 05/24/2002SE |
| K012469 | Resorbable No Profile Screw and WasherHWC · Traditional | 12/03/2001SE |
| K012503 | Metal Screw AnchorMBI · Traditional | 10/22/2001SE |
| K010657 | Copeland MB Resurfacing Humeral HeadsHSD · Traditional | 09/14/2001SE |
| K010664 | Copeland Resurfacing Humeral HeadsHSD · Special | 04/05/2001SE |
| K002020 | Lactosorb Meniscal ScrewMAI · Traditional | 08/25/2000SE |
| K001374 | Patient Matched Cobalt Alloy Trochlea ReplacementKRR · Traditional | 07/27/2000SE |
| K000262 | Bohn Femoral ComponentMEH · Traditional | 04/03/2000SE |
| K994326 | Ascent Knee SystemKWH · Special | 01/07/2000SE |
| K993111 | Ascent Knee SystemJWH · Special | 10/05/1999SE |
| K992301 | Reunite ScrewsHWC · Traditional | 09/01/1999SE |
PMA approvals
- P010014 Oxford(Tm) Meniscal Unicompartmental Knee System · 04/21/2004 · 106 supplements