# K961727: Natural-Hip System - Calcar Replacement Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Jul 19, 1996 after 77 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 K902712 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945516: Natural-Hip (TM) System - Calcar Replcement Stem, Intermedics Orthopedics (1995) Summary page 1.
- K902712: Osteonics PS Head and Neck Hip Stem Series, Osteonics Corp. (1990) Summary page 1.
- (no number) Omnifit Head/Neck Hip Stem: named in the summary without a submission number
- (no number) Cemented Calcar Stem: named in the summary without a submission number

## Indications for use
The Calcar Replacement Hip Stem is intended for use in treatment of intertrochanteric, comminuted, or femoral neck fracture; trochanteric non-union; erosion of calcar or femoral neck, and; revision total hip arthroplasty involving bone loss in the proximal femur or tumors. In addition, the Calcar Replacement Hip Stem like the predicate IOI and competitive hip stems is intended for cemented application in cases of total hip arthroplasty. 1. Patient conditions of intertrochanteric, comminuted or femoral neck fracture 2. Trochanteric nonunion 3. Erosion of the calcar or femoral neck 4. Revision total hip arthroplasty involving bone loss in the proximal femur 5. Tumors.

Source page: https://510kreport.com/device/K961727
Methodology: https://510kreport.com/methodology