# K961589: Apr Fully Textured Hip Stem

- Pathway: 510(k) (Traditional)
- Applicant: Intermedics Orthopedics
- Decided: Jul 9, 1996 after 76 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bi-Metric Primary Interlok Hip Stem: named in the summary without a submission number
- (no number) Alloclassic Zweymüller Cementless Stem: named in the summary without a submission number

## Indications for use
The APR® Fully Textured Hip Stem is intended for prosthetic replacement of the proximal portion of the femur in a hip replacement.

Source page: https://510kreport.com/device/K961589
Methodology: https://510kreport.com/methodology