# K964357: Natural-Hip System Cocr Stem

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Jan 27, 1997 after 87 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 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) Premier Hip Stem: named in the summary without a submission number
- (no number) ODC Hip Stem: named in the summary without a submission number
- (no number) Perfecta IMC Stem: named in the summary without a submission number

## Indications for use
The Narral-Hip System CoCr Stem is intended to replace the anatomy of the femur in cases of total hip or hemi-hip replacement. The Natral-Hip Systern CoCr Stem is intended for cemented application only. The general indications associated with the use of Natural-Hip System CoCr Stem in total hip arthroplasty include: 1. Patient conditions of non-inflammatory degenerative joint disease (NIDID), e.g., avascular necrosis, osteoarthritis and inflammatory joint discase (1JD), e.g., rheumatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity or dysfunction persists. 3. Revision of previously failed arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient, and modified demands regarding activity and hip joint loading arc assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives.

Source page: https://510kreport.com/device/K964357
Methodology: https://510kreport.com/methodology