# K113271: Metal-on-Metal Hip Systems-Additional Contraindications

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: May 18, 2012 after 196 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: 6 generations back to K881288 (1988). 50 ancestors in all.
No later device cites it as a predicate yet.
0 of 51 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.
- K011110: M2A Acetabular System, Biomet, Inc. (2001)
- K042037: M2A Magnum System, Biomet, Inc. (2004) Summary page 1.
- K042841: M2A/C2A Acetabular System, Biomet, Inc. (2004) 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.
- K082446: Biomet Metal-on-Metal Hip Systems- Expanded Contraindications, Biomet, Inc. (2008) Summary page 1.

## Indications for use
1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. (a) Revision procedures where other treatment or devices have failed (M2a-Taper™ and M2a-Ringloc™). (b) Revision of previously failed total hip arthroplasty (M2a-Magnum™ and M2a-38™). 5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. The components of the M2a Magnum™ system were also cleared for diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, slipped capital epiphysis, subcaptial fractures, and traumatic arthritis indications. The M2a-Taper™ Metal-on-Metal Hip Joint Replacement Prosthesis are intended for use in cemented and non-cemented primary and revision hip joint arthroplastic procedures.

Source page: https://510kreport.com/device/K113271
Methodology: https://510kreport.com/methodology