# K971523: Distally Fixed Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Oct 1, 1997 after 156 days
- Product code: MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Restoration HA Hip Stem: named in the summary without a submission number
- (no number) Sentry Femoral Component: named in the summary without a submission number
- (no number) S-ROM® Femoral Prosthesis: named in the summary without a submission number
- (no number) Stability Hip Stem: named in the summary without a submission number
- (no number) Wagner Revision Stem: named in the summary without a submission number

## Indications for use
1. Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (UD), e.g., rheumatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists. 3. Revision of previously failed arthroplasty.

Source page: https://510kreport.com/device/K971523
Methodology: https://510kreport.com/methodology