# K042841: M2A/C2A Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Dec 21, 2004 after 68 days
- Product code: JDL (Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K861114 (1986). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 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.
- K003363: M2A 32MM Taper System, Biomet, Inc. (2000) Summary page 1.
- K861114: Mallory/Head - PF Acetabular Component, Biomet, Inc. (1986) Summary page 1.

## Most influential descendants
- K113271: Metal-on-Metal Hip Systems-Additional Contraindications (2012), 0 descendants of its own

## Indications for use
The M2 aTM/C 2 aTM Acetabular System is intended for cemented or non-cemented use in cases of: 1) Non-inflammatory 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 been unsuccessful 5) Treatment of non-union, femoral neck fracture, trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

Source page: https://510kreport.com/device/K042841
Methodology: https://510kreport.com/methodology