510(k) K023546 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
MAXIM ACCEL KNEE SYSTEM
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jan 17, 2003 |
| Received | Oct 22, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023546
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 17, 2020 | Biomet, Inc. Knee Products:
183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM
183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM
189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 6 Terminated |
JWH | None listed |
| Apr 17, 2020 | Biomet, Inc. Knee
Products:
183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM
EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM
EP-183608 Vanguard Knee System, PS Terminated |
JWH | None listed |
| Oct 22, 2018 | Zimmer Biomet, Inc. Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm
Item Number: 183126 Terminated |
JWH | None listed |
| Oct 22, 2018 | Zimmer Biomet, Inc. Vanguard Knee System -PS Open Box Femoral Right, 65 mm
Item Number:183108 Terminated |
JWH | None listed |
| Sep 29, 2017 | Zimmer Biomet, Inc. Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442
Product Usage:
For use in total knee arthroplasty Terminated |
JWH | None listed |
| Sep 29, 2017 | Zimmer Biomet, Inc. Vanguard Complete Knee System, Vanguard CR Lipped Tibial Bearing 10x71/75, Item Number: 183540
Product Usage:
For use in total knee arthroplasty Terminated |
JWH | None listed |
| Jan 4, 2017 | Zimmer Biomet, Inc. Vanguard Total Knee System
Vanguard Open Box Femoral Components
Item Number: 183100
Description: VNGD PS OPEN INTL FEM RT 55
Item Number: 183102
Description: VNGD PS OPEN INTL FEM-RT 57.5
Item Number Terminated |
JWH | None listed |
| Oct 18, 2016 | Zimmer Biomet, Inc. Vanguard Distal Femoral Augment 75 X 5 RL/LM
Product Usage:
Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments ar Terminated |
JWH | None listed |
| Aug 4, 2011 | Biomet, Inc. Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY.
Biomet, Inc.
A knee joint replacement prosthesis non-coated femoral indicated for cemented application onl Terminated |
JWH | None listed |
| Aug 10, 2010 | Biomet, Inc. Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component. Terminated |
JWH | None listed |
| Jul 25, 2008 | Biomet, Inc. Biomet Vanguard DCM CR Tibial Bearing, 18MM x 71/75MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183448. Terminated |
JWH | None listed |
| Jul 25, 2008 | Biomet, Inc. Biomet Vanguard DCM CR Tibial Bearing, 14MM x 79/83MM, CR STD bearing, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Part 183464. Terminated |
JWH | None listed |
| Dec 5, 2007 | Biomet, Inc. Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Biomet Orthopedics, Inc., Warsaw, IN 46581 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.