# K033943: Alpha Metasul 28MM and 32MM Acetabular Inserts, Standard and Hooded

- Pathway: 510(k) (Traditional)
- Applicant: Centerpulse Orthopedics, Inc.
- Decided: Oct 18, 2004 after 304 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
Longest line of descent: 1 generation back to K002379 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003758: Allofit Acetabular System, Sulzer Orthopedics, Inc. (2001) Summary page 1.
- K002379: M2A 28MM Ringloc Liner, Biomet, Inc. (2000) Summary page 1.
- K003363: M2A 32MM Taper System, Biomet, Inc. (2000) Summary page 1.

## Indications for use
The AlphaTM Metasul®) Acetabular Insert is intended for use in total hip arthroplasty for treatment of the following: * patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis; * those patients with failed previous surgery where pain, deformity, or dysfunction persists; * revision of previously failed hip arthroplasty.

Source page: https://510kreport.com/device/K033943
Methodology: https://510kreport.com/methodology