# K070369: Regenerx Ringloc + Modular Acetabular Shells

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Mar 9, 2007 after 29 days
- Product code: LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3358
- Recalls of this device: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K854046 (1985). 19 ancestors in all.
137 later devices descend from it; 5 cite 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)
- K050124: Porous Coated Acetabular Components, Biomet, Inc. (2005) Summary page 1.

## Most influential descendants
- 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
- K122158: PBP Total Hip System (2012), 21 descendants of its own

## Recalls of this device
- Apr 14, 2011 · Not classified · Z-2465-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2457-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2453-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2466-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2448-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2458-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2462-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2449-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2452-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2461-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2455-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2464-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2456-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2450-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2451-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2460-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2454-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2459-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th
- Apr 14, 2011 · Not classified · Z-2463-2011: The firm has initiated this action following an investigation which found that the locking ring may be assembled incorrectly in the acetabular shell. If the locking ring is incorrectly assembled in th

## 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. 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, bone loss, joint or 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/K070369
Methodology: https://510kreport.com/methodology