# K993438: Metal on Metal Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: May 18, 2000 after 219 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.
117 later devices descend from it; 7 cite it directly.
0 of 118 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) Mallory Head Finned Acetabular Cup: named in the summary without a submission number
- (no number) Universal Acetabular Cup: named in the summary without a submission number
- (no number) Biomet Co-Cr Femoral Components: named in the summary without a submission number
- (no number) Sulzer’s Inter-Op Metasul: 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

## Indications for use
The Metal on Metal Acetabular System is indicated for used in patients requiring total hip replacement due to the following: a.) Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, leg perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures, and traumatic arthritis b.) Rheumatoid arthritis c.) Correction of functional deformity d.) Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. e.) Revision of previously failed total hip arthroplasty.

Source page: https://510kreport.com/device/K993438
Methodology: https://510kreport.com/methodology