# K050124: Porous Coated Acetabular Components

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Oct 4, 2005 after 258 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K854046 (1985). 18 ancestors in all.
138 later devices descend from it; 1 cites it directly.
0 of 157 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921277: Ranawat/Burstein Total Hip System, Biomet, Inc. (1994) Summary page 1.
- K920640: Full Hemisphere Ring-Loc Liner, Biomet, Inc. (1992) Summary page 1.
- K030055: Mallory/Head Total Hip System; HA Mallory/Head Total Hip System; BI-Metric Femoral Components, Biomet, Inc. (2003) Summary page 1.

## Most influential descendants
- K070369: Regenerx Ringloc + Modular Acetabular Shells (2007), 137 descendants of its own
- K093235: Ringloc + Hybrid Acetabular System (2010), 65 descendants of its own
- K121874: G7 Acetabular System (2012), 53 descendants of its own
- K112802: Pipeline Total Hip System (2012), 53 descendants of its own
- K140669: G7 Osseoti Acetublar Shells (2014), 35 descendants of its own

## Recalls of this device
- Oct 4, 2012 · Class II · Z-0415-2013: The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)

## Indications for use
Cemented or non-cemented total hip replacement in cases of 1) Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis 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 procedures where other treatment or devices have failed. M2aTM Ring-Loc liners are only cleared for use in non-cemented acetabular shells. The indications for use of the constrained liners compatible with this system are as follow: The devices are intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

Source page: https://510kreport.com/device/K050124
Methodology: https://510kreport.com/methodology