# K973124: Apr Porous HA Hip System

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Nov 3, 1997 after 75 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 1 (0 Class I)
- 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) Natural-Hip HA Stem: named in the summary without a submission number
- (no number) APR Universal Hip Stem with Calcitite®-Coated CSTi: named in the summary without a submission number

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0318-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

## Indications for use
1. Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis and inflammatory joint disease (IID), e.g., rheumatoid arthritis. 2. Those patients with failed previous surgery where pain, deformity, or dysfunction persists. 3. Revision of previously failed arthroplasty. The APR Porous HA System is intended only for use without bone cement.

Source page: https://510kreport.com/device/K973124
Methodology: https://510kreport.com/methodology