Company · US
Biomet Orthopedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2026. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (2 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HRS | Plate, Fixation, Bone | 4 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 4 |
| HWC | Screw, Fixation, Bone | 4 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 4 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 3 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 2 |
| KXA | Prosthesis, Hip, Femoral, Resurfacing | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 |
| MQV | Filler, Bone Void, Calcium Compound | 2 |
| HRX | Arthroscope | 1 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 |
| JDC | Prosthesis, Elbow, Constrained, Cemented | 1 |
| KWZ | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | 1 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 1 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 1 |
| MBF | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | 1 |
| PHX | Shoulder Prosthesis, Reverse Configuration | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 24, 2026 | K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and Augments Biomet Orthopedics, Inc. | JDI |
| Apr 15, 2026 | K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates Biomet Orthopedics | PHX |
| Feb 19, 2025 | K243761 | A.L.P.S. Small Fragment Plating System Biomet Orthopedics | HRS |
| Jul 12, 2023 | K223631 | Comprehensive Segmental Revision System(SRS) Biomet Orthopedics | KWT |
| Dec 8, 2020 | K200196 | Taperloc® Complete Hip Stems Biomet Orthopedics | LZO |
| Oct 24, 2013 | K131393 | MAK OSS FEMORAL KNEE COMPONENTS Biomet Orthopedics Corp. | KRO |
| May 24, 2012 | K112905 | COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM Biomet Orthopedics, LLC | MBF |
| Jun 17, 2008 | K080528 | E-POLY TIBIAL BEARINGS Biomet Orthopedics, Inc. | JWH |
| Jan 14, 2008 | K072879 | INNERVUE DIAGNOSTIC SCOPE SYSTEM Biomet Orthopedics, Inc. | HRX |
| Oct 12, 2007 | K070955 | ACID ETCHED LAG SCREWS Biomet Orthopedics, Inc. | HSB |
| Jun 30, 2004 | K033355 | LACTOSCREW SCREW ANCHOR Biomet Orthopedics, Inc. | HWC |
| Nov 20, 2003 | K032286 | CALCIGEN PSI BONE GRAFT SUBSTITUTE Biomet Orthopedics, Inc. | MQV |
| Feb 5, 2003 | K030048 | HA PMI FEMORAL HIP STEM Biomet Orthopedics, Inc. | LPH |
| Jan 9, 2003 | K024086 | PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM Biomet Orthopedics, Inc. | HWC |
| Dec 13, 2002 | K023063 | COMPREHENSIVE HUMERAL FRACTURE SYSTEM Biomet Orthopedics, Inc. | KWT |
| Dec 11, 2002 | K023188 | PRESS-FIT HEAD RESURFACING DEVICE Biomet Orthopedics, Inc. | KXA |
| Nov 6, 2002 | K023357 | ARCPM 1050 RESIN-HIPS Biomet Orthopedics, Inc. | LPH |
| Oct 25, 2002 | K021661 | RINGLOC CONSTRAINED LINERS Biomet Orthopedics, Inc. | KWZ |
| Oct 17, 2002 | K023085 | RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM Biomet Orthopedics, Inc. | JDI |
| Sep 17, 2002 | K022515 | BIOMET CALCANEAL PLATE Biomet Orthopedics, Inc. | HRS |
| Aug 16, 2002 | K022463 | HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS Biomet Orthopedics, Inc. | LPH |
| Aug 15, 2002 | K022586 | ANTERIOR STABILIZED TIBIAL BEARINGS Biomet Orthopedics, Inc. | JWH |
| Jul 17, 2002 | K021254 | LACTOSORB MINI INTERFERENCE SCREW Biomet Orthopedics, Inc. | HWC |
| Jun 26, 2002 | K021799 | CEMENTED FEMORAL HEAD RESURFING DEVICE Biomet Orthopedics, Inc. | KXA |
| Jun 11, 2002 | K013790 | CALCIGEN-S BONE VOID FILER Biomet Orthopedics, Inc. | MQV |
| May 31, 2002 | K021403 | HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM Biomet Orthopedics, Inc. | MEH |
| May 6, 2002 | K020381 | EXPANDABLE KNEE Biomet Orthopedics, Inc. | KRO |
| Apr 16, 2002 | K020963 | TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM Biomet Orthopedics, Inc. | MEH |
| Apr 15, 2002 | K020905 | NBX - NON-BRIDGING EXTERNAL FIXATOR Biomet Orthopedics, Inc. | LXT |
| Apr 2, 2002 | K020221 | IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET Biomet Orthopedics, Inc. | HRS |
| Feb 25, 2002 | K013923 | TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER Biomet Orthopedics, Inc. | HSB |
| Feb 8, 2002 | K020264 | REPICCI II UNICONDYLAR KNEE SYSTEM Biomet Orthopedics, Inc. | HRY |
| Jan 30, 2002 | K020076 | PATRIOT PROTRUSIO CAGE Biomet Orthopedics, Inc. | JDI |
| Jan 30, 2002 | K020045 | 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM Biomet Orthopedics, Inc. | KWT |
| Dec 17, 2001 | K013534 | SELF-COUNTERSINKING BONE SCREW Biomet Orthopedics, Inc. | HWC |
| Dec 3, 2001 | K013657 | MODIFICATION TO: BIOMET HUMERAL CABLE PLATES Biomet Orthopedics, Inc. | HRS |
| Oct 10, 2001 | K013042 | DISCOVERY ELBOW Biomet Orthopedics, Inc. | JDC |
| Sep 14, 2001 | K010827 | COPELAND MB/HA RESURFACING HUMERAL HEADS Biomet Orthopedics, Inc. | HSD |
| Oct 23, 2000 | K002278 | BROOKER FEMORAL NAILS Biomet Orthopedics, Inc. | HSB |
| Oct 4, 2000 | K002057 | BROOKER TIBIA NAILS Biomet Orthopedics, Inc. | HSB |
| Jun 14, 2000 | K001660 | MALLORY HEAD MODULAR CALCAR Biomet Orthopedics, Inc. | LPH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||