# K082826: Vanguard CR Stem Housings

- Pathway: 510(k) (Special)
- Applicant: Biomet Manufacturing Corp
- Decided: Oct 24, 2008 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: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K963709 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963709: Cement-on Femoral Stem, Biomet, Inc. (1996) Summary page 1.

## 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. VanguardTM CR Stem Housings are indicated for use with VanguardTM CR Femorals. The devices are single-use implants intended for cemented applications.

Source page: https://510kreport.com/device/K082826
Methodology: https://510kreport.com/methodology