# K973675: Natural-Hip Porous Stem with Offset

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Dec 19, 1997 after 84 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
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) Sulzer Orthopedics Natural-Hip Porous Stem: named in the summary without a submission number
- (no number) Howmedica Precision Strata Offset Stem: named in the summary without a submission number
- (no number) Johnson & Johnson PFC Offset Stem: named in the summary without a submission number
- (no number) DePuy Endurance Offset Stem: named in the summary without a submission number
- (no number) DePuy Stability Offset Stem: named in the summary without a submission number
- (no number) Osteonics Omnifit Enhanced Offset Stem: named in the summary without a submission number

## Indications for use
The Natural-Hip Porous Stem with Offset is intended for use in cases of hemi- or total hip replacement for treatment of the following: 1. Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (I1D), e.g., rheumnatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity or dysfunction persists. 3. Revision of previously failed hip arthroplasty.

Source page: https://510kreport.com/device/K973675
Methodology: https://510kreport.com/methodology