# K082446: Biomet Metal-on-Metal Hip Systems- Expanded Contraindications

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 15, 2008 after 51 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
Longest line of descent: 5 generations back to K881288 (1988). 47 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993438: Metal on Metal Acetabular System, Biomet, Inc. (2000) 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.
- K011110: M2A Acetabular System, Biomet, Inc. (2001) Summary page 1.
- K042037: M2A Magnum System, Biomet, Inc. (2004) Summary page 1.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 1.
- K061423: M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads, Biomet Manufacturing Corp (2006) Summary page 1.
- K062995: M2A-Magnum Tri-Spike Acetabular Component, Biomet Manufacturing Corp (2006) Summary page 1.

## Most influential descendants
- K113271: Metal-on-Metal Hip Systems-Additional Contraindications (2012), 0 descendants of its own
- K083642: Depuy Pinnacle Metal-on-Metal Acetabular Cup Liners (2009), 0 descendants of its own

## Recalls of this device
- Nov 25, 2020 · Class II · Z-0627-2021: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

## Indications for use
K993438, K011110, K042037, K043537, K061423, K062995: 1. Non-inflammatory degenerative joint disease including avascular necrosis, diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, osteoarthritis, slipped capital epiphysis, subcapital fractures, and traumatic arthritis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. K002379, K003363: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Revision procedures where other treatment or devices have failed. 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

Source page: https://510kreport.com/device/K082446
Methodology: https://510kreport.com/methodology