Biomet Orthopedics, Inc.
Warsaw, IN, US
Biomet Orthopedics, Inc. appears in FDA device records in Warsaw, IN. FDA records list 40 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 40
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 40 510(k) clearances for Biomet Orthopedics, Inc. between 2000 and 2026. The busiest year on record is 2002, with 20. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 3 |
| 2001 | 4 |
| 2002 | 20 |
| 2003 | 3 |
| 2004 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2012 | 1 |
| 2013 | 1 |
| 2020 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | PHX | Substantially Equivalent | |
| K243761 | A.L.P.S. Small Fragment Plating System | HRS | Substantially Equivalent | |
| K223631 | Comprehensive Segmental Revision System(SRS) | KWT | Substantially Equivalent | |
| K200196 | Taperloc® Complete Hip Stems | LZO | Substantially Equivalent | |
| K131393 | MAK OSS FEMORAL KNEE COMPONENTS | KRO | Substantially Equivalent | |
| K112905 | COMPRESS(R) SEGMENTAL HUMERAL REPLACEMENT SYSTEM | MBF | Substantially Equivalent | |
| K080528 | E-POLY TIBIAL BEARINGS | JWH | Substantially Equivalent | |
| K072879 | INNERVUE DIAGNOSTIC SCOPE SYSTEM | HRX | Substantially Equivalent | |
| K070955 | ACID ETCHED LAG SCREWS | HSB | Substantially Equivalent | |
| K033355 | LACTOSCREW SCREW ANCHOR | HWC | Substantially Equivalent | |
| K032286 | CALCIGEN PSI BONE GRAFT SUBSTITUTE | MQV | Substantially Equivalent | |
| K030048 | HA PMI FEMORAL HIP STEM | LPH | Substantially Equivalent | |
| K024086 | PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM | HWC | Substantially Equivalent | |
| K023063 | COMPREHENSIVE HUMERAL FRACTURE SYSTEM | KWT | Substantially Equivalent | |
| K023188 | PRESS-FIT HEAD RESURFACING DEVICE | KXA | Substantially Equivalent | |
| K023357 | ARCPM 1050 RESIN-HIPS | LPH | Substantially Equivalent | |
| K021661 | RINGLOC CONSTRAINED LINERS | KWZ | Substantially Equivalent | |
| K023085 | RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM | JDI | Substantially Equivalent | |
| K022515 | BIOMET CALCANEAL PLATE | HRS | Substantially Equivalent | |
| K022463 | HA MODULAR REACH PROXIMAL POROUS AND HA MODULAR REACH COLLARED PROXIMAL POROUS FEMORAL STEMS | LPH | Substantially Equivalent | |
| K022586 | ANTERIOR STABILIZED TIBIAL BEARINGS | JWH | Substantially Equivalent | |
| K021254 | LACTOSORB MINI INTERFERENCE SCREW | HWC | Substantially Equivalent | |
| K021799 | CEMENTED FEMORAL HEAD RESURFING DEVICE | KXA | Substantially Equivalent | |
| K013790 | CALCIGEN-S BONE VOID FILER | MQV | Substantially Equivalent | |
| K021403 | HA MALLORY/HEAD POROUS FEMORAL STEM & HA MALLORY/HEAD POROUS LATERALIZED FEMORAL STEM | MEH | Substantially Equivalent | |
| K020381 | EXPANDABLE KNEE | KRO | Substantially Equivalent | |
| K020963 | TAPERLOC POROUS FEMORAL STEM & HA TAPERLOC POROUS LATERALIZED FEMORAL STEM | MEH | Substantially Equivalent | |
| K020905 | NBX - NON-BRIDGING EXTERNAL FIXATOR | LXT | Substantially Equivalent | |
| K020221 | IQL BASIC FRAGMENT PLATE SET, IQL BASIC FRAGMENT SCREW SET, IQL SMALL FRAGMENT SET, IQL MINI FRAGMENT SET | HRS | Substantially Equivalent | |
| K013923 | TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER | HSB | Substantially Equivalent | |
| K020264 | REPICCI II UNICONDYLAR KNEE SYSTEM | HRY | Substantially Equivalent | |
| K020076 | PATRIOT PROTRUSIO CAGE | JDI | Substantially Equivalent | |
| K020045 | 3-PIECE PROXIMAL HUMERAL REPLACEMENT SYSTEM | KWT | Substantially Equivalent | |
| K013534 | SELF-COUNTERSINKING BONE SCREW | HWC | Substantially Equivalent | |
| K013657 | MODIFICATION TO: BIOMET HUMERAL CABLE PLATES | HRS | Substantially Equivalent | |
| K013042 | DISCOVERY ELBOW | JDC | Substantially Equivalent | |
| K010827 | COPELAND MB/HA RESURFACING HUMERAL HEADS | HSD | Substantially Equivalent | |
| K002278 | BROOKER FEMORAL NAILS | HSB | Substantially Equivalent | |
| K002057 | BROOKER TIBIA NAILS | HSB | Substantially Equivalent | |
| K001660 | MALLORY HEAD MODULAR CALCAR | LPH | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LXTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
- HRXArthroscope
- MQVFiller, Bone Void, Calcium Compound
- HRSPlate, Fixation, Bone
- JDCProsthesis, Elbow, Constrained, Cemented
- KWZProsthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- KXAProsthesis, Hip, Femoral, Resurfacing
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- KROProsthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
- KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
- MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- PHXShoulder Prosthesis, Reverse Configuration
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain