# K041046: Maxim Accel (Vanguard) PS+ Bearings

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: May 21, 2004 after 29 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K915132 (1992). 3 ancestors in all.
249 later devices descend from it; 3 cite it directly.
0 of 253 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023546: Maxim Accel Knee System, Biomet, Inc. (2003) Summary page 1.

## Most influential descendants
- K080528: E-Poly Tibial Bearings (2008), 248 descendants of its own
- K091956: Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712 (2010), 119 descendants of its own
- K100048: E1 Antioxidant Infused Technology (2010), 114 descendants of its own
- K120370: Vivacit-E Vitamin E Highly Crosslinked Polyethylene Liners (2012), 88 descendants of its own
- K121771: Zimmer Persona the Personalized Knee System (2012), 59 descendants of its own

## Recalls of this device
- Sep 22, 2008 · Not classified · Z-0289-2009: The package is properly labeled, but the laser etch for size incorrectly reads "16 X 63/63" instead of the correct size, "16 X 63/67".

## Indications for use
1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. The device is a single use implant intended for implantation with bone cement.

Source page: https://510kreport.com/device/K041046
Methodology: https://510kreport.com/methodology