# K042037: M2A Magnum System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 1, 2004 after 64 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: 3 generations back to K881288 (1988). 14 ancestors in all.
116 later devices descend from it; 8 cite it directly.
0 of 131 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011110: M2A Acetabular System, Biomet, Inc. (2001) Summary page 1.
- K984028: The New Bio-Moore Endo Heads, Biomet, Inc. (1999) Summary page 1.
- K002106: New Bio-Moore Endo Head, Taper Adapter, Biomet, Inc. (2000) Summary page 1.
- K031963: Conserve Plus Spiked Acetabular Shells and Conserve Total 56MM Femoral Head, Wrightmedicaltechnologyinc (2003) Summary page 1.
- K021349: Metal Transcend Articulation System (Larger Sizes), Wrightmedicaltechnologyinc (2002). Our reading of the summary gave K021249, FDA’s number for Surgassist Flexshaft 2, Model FS2 14 (Power Medical Interventions, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Metal Transcend Articulation System”.

## Most influential descendants
- 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
- K062995: M2A-Magnum Tri-Spike Acetabular Component (2006), 26 descendants of its own

## Indications for use
The M2aTM Magnum TM System is indicated for use in patients requiring total hip replacement due to the following: * 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. * Rheumatoid arthritis * Correction of functional deformity * Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques * Revision of previously failed total hip arthroplasty

Source page: https://510kreport.com/device/K042037
Methodology: https://510kreport.com/methodology