# K974728: Inter-OP Metasul Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Aug 3, 1999 after 593 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- 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.
77 later devices descend from it; 2 cite it directly.
0 of 78 devices 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) McKee-Farrar Total Hip: named in the summary without a submission number
- (no number) Ring Total Hip: named in the summary without a submission number
- (no number) Sivash Total Hip: named in the summary without a submission number

## Most influential descendants
- K033634: Epsilon Metasul 32MM Acetabular Inserts, Standard and Hooded (2004), 76 descendants of its own
- K053536: Durom Acetabular Component and Metasul LDH Large Diameter Heads (2006), 74 descendants of its own
- K071723: Zimmer Porolock Mis Stem (2008), 73 descendants of its own
- K123392: Avenir Muller Stem (2013), 41 descendants of its own
- K110400: Taperloc Complete Microplasty Stem (2011), 34 descendants of its own

## Recalls of this device
- Dec 17, 2014 · Class II · Z-1136-2015: Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is con

## Indications for use
The Inter-Op Metasul Acetabular System is intended for use in cases of total hip replacement 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 (UD), 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/K974728
Methodology: https://510kreport.com/methodology