# K061423: M2A Magnum 12/14 Taper Inserts and One-Piece Modular Heads

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Jul 27, 2006 after 65 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: 4 generations back to K881288 (1988). 42 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042037: M2A Magnum System, Biomet, Inc. (2004) Summary page 1.
- K040627: Depuy Asr Modular Acetabular Cup System, DePuy Orthopaedics, Inc. (2005) Summary page 1.
- K043537: Taperloc 12/14 Taper Femoral Components, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- K082446: Biomet Metal-on-Metal Hip Systems- Expanded Contraindications (2008), 2 descendants of its own
- 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

## Indications for use
The M2a Magnum TM 12/14 Taper Inserts and One-Piece Modular Heads are indicated for use in patients requiring total hip replacement due to the following: 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 by other techniques. 5. Revision of previously failed total hip arthroplasty.

Source page: https://510kreport.com/device/K061423
Methodology: https://510kreport.com/methodology