# K960258: Natural Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Jul 12, 1996 after 176 days
- Product code: JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3350
- 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 K894051 (1989). 1 ancestor in all.
6 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894051: Premier-Total Hip, Intermedics Orthopedics (1989) Summary page 1.
- (no number) Osteonics ODC Cemented Hip Stem: named in the summary without a submission number
- (no number) Osteonics ODC Hip Stem: named in the summary without a submission number
- (no number) PFC Cemented Hip Stem: named in the summary without a submission number
- (no number) Perfecta IMC Stem: named in the summary without a submission number

## Most influential descendants
- K172857: Latitud Hip Replacement System (2018), 5 descendants of its own
- K180973: Libertas Hip Replacement System (2018), 3 descendants of its own
- K253171: Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) (2026), 0 descendants of its own
- K222436: Latitud™ Hip Replacement System (2023), 0 descendants of its own
- K192989: Libertas E-XLPE Modular Liner (2020), 0 descendants of its own

## Indications for use
1. Patient conditions of noninflammatory 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. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient (see "Warnings and Precautions"), and modified demands regarding activity and hip joint loading are 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/K960258
Methodology: https://510kreport.com/methodology