# K993569: Apr Metasul Acetabular Insert

- Pathway: 510(k) (Special)
- Applicant: Sulzermedica
- Decided: Dec 1, 1999 after 41 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- 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) APR Acetabular System: named in the summary without a submission number
- (no number) Inter-Op Metasul Acetabular System: named in the summary without a submission number

## Indications for use
The APR Metasul Acetabular Inserts are intended for use with the APR Acetabular Shells and Metasul femoral heads in total hip arthroplasty for treatment of the following: 1. Patient conditions of non-inflammatory degenerative joint disease (NIDJD), e.g., osteoarthritis, post traumatic arthritis or avascular necrosis and inflammatory degenerative 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 hip arthroplasty.

Source page: https://510kreport.com/device/K993569
Methodology: https://510kreport.com/methodology