# K211047: CoCr Head

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Jan 10, 2023 after 642 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K955033 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993259: Inter-OP Durasul Acetabular Inserts/Cocr Femoral Heads, Sulzer Orthopedics, Inc. (2000) Summary page 4.

## Indications for use
Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., theumatoid arthritis. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty.

Source page: https://510kreport.com/device/K211047
Methodology: https://510kreport.com/methodology