# K011110: M2A Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 2, 2001 after 82 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
No predicates in its family tree.
228 later devices descend from it; 6 cite it directly.
0 of 229 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K043537: Taperloc 12/14 Taper Femoral Components (2005), 160 descendants of its own
- K042037: M2A Magnum System (2004), 116 descendants of its own
- 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
- K121874: G7 Acetabular System (2012), 53 descendants of its own

Source page: https://510kreport.com/device/K011110
Methodology: https://510kreport.com/methodology