# K970300: Natural-Hip System Porous Stem with HA/Csti

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Jul 3, 1997 after 160 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: 1 generation back to K944209 (1994). 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)
- K944209: Apr II Non Porous Hip Stem, Intermedics Orthopedics (1994). Our OCR of the scanned summary read “K944209” beside “510(k)”; FDA’s K944209 is the only number that fits it and carries the summary’s name for the device. Summary page 1.
- (no number) APR Universal Hip System with Calcitite®-Coated CSTi: named in the summary without a submission number
- (no number) Howmedica Precision Osteolock: named in the summary without a submission number
- (no number) Osteonics Omnifit with HA: 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 (IID), e.g., rheumatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists. 3. Revision of previously failed arthroplasty. The Natural-Hip™ System Porous Stem with HA/CSTi™ is intended only for use without bone cement.

Source page: https://510kreport.com/device/K970300
Methodology: https://510kreport.com/methodology