# K970166: Natural-Hip System Cocr Revision Stem

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Apr 8, 1997 after 82 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- 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
Longest line of descent: 1 generation back to K952859 (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)
- K952859: Ultima Cemented Long Stem Femoral Component, Johnson & Johnson Professionals, Inc. (1996) Summary page 2.
- (no number) Omnifit® Long Stem: named in the summary without a submission number
- (no number) PCA® Long Stem: named in the summary without a submission number
- (no number) Matrix Cementra® Revision Femoral Stem: named in the summary without a submission number

## Indications for use
The Natural-Hip System CoCr Revision Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natural-Hip System CoCr Revision Stem is intended for cemented application only and is intended for single use only. The Natural-Hip System CoCr Revision Stem is intended for use in treatment of the following: 1. Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IJD), 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/K970166
Methodology: https://510kreport.com/methodology