510(k) K915132 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Feb 11, 1992 |
| Received | Nov 13, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K915132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2018 | Zimmer Biomet, Inc. Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340
Product is used in Total Knee Arthroplasty Terminated |
JWH | None listed |
| Jun 11, 2015 | Biomet, Inc. MCK Maximum Congruent Knee System, BIOMET FINNED PRI STEM 40MM; 80 x 10MM; 80 x 12.5 MM; 80 x 15 MM
Knee joint replacement prostheses components include femoral, tibial, and patellar components. Terminated |
JWH | None listed |
| Apr 28, 2011 | Biomet, Inc. Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141224, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prosthes Terminated |
JWH | None listed |
| Jan 31, 2008 | Biomet, Inc. Biomet CC Cruciate Tibial Tray, 67 mm.; Product No. 141232, Biomet, Inc., Warsaw, IN 46581 Terminated |
JWH | None listed |
| Jan 31, 2008 | Biomet, Inc. Biomet CC Cruciate Tibial Tray, 75 mm.; Product No. 141234, Biomet, Inc., Warsaw, IN 46581 Terminated |
JWH | None listed |
| Nov 24, 2007 | Biomet, Inc. Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN 46582 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.