# K961799: Natural Hip System - DRG Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Jul 15, 1996 after 67 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.
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)
- 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) Pertecta IMC Stem: named in the summary without a submission number

## Indications for use
The DRG Hip Stem is intended to replace the anatomy of the femur in cases of total hip replacement. In addition, the DRG Hip Stem, like the predicate IOI and competitive hip stems, is intended for cemented or cementless (press-fit) application in cases of total hip arthroplasty. The general indications associated with the use of DRG Stem in total hip arthroplasty include: 1. Patient conditions of inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (ID), e.g., rheumatoid arthritis. Those patients with failed previous surgery where pain, deformity or dysfunction persists. 3 Revision of previously failed arthroplasty.

Source page: https://510kreport.com/device/K961799
Methodology: https://510kreport.com/methodology