# K093235: Ringloc + Hybrid Acetabular System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 30, 2010 after 197 days
- Product code: KWA (Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component))
- Device class: 3
- Regulation: 21 CFR 888.3330
- Recalls of this device: 30 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K854046 (1985). 21 ancestors in all.
65 later devices descend from it; 3 cite it directly.
0 of 87 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002379: M2A 28MM Ringloc Liner, Biomet, Inc. (2000) Summary page 1.
- K070369: Regenerx Ringloc + Modular Acetabular Shells, Biomet, Inc. (2007) Summary page 1.

## Most influential descendants
- K121874: G7 Acetabular System (2012), 53 descendants of its own
- K140669: G7 Osseoti Acetublar Shells (2014), 35 descendants of its own
- K142882: G7 Freedom and Offset Liners, Freedom Head, Size 32 (2015), 17 descendants of its own
- K221479: Persona Personalized Knee System (2022), 8 descendants of its own
- K182321: MobileLink Acetabular Cup System (2019), 8 descendants of its own

## Recalls of this device
- Jun 29, 2017 · Class II · Z-0312-2018: Device was distributed with the etching missing from the product.
- Jul 28, 2015 · Class II · Z-2483-2015: The device was assembled without screw hole plugs.
- Jan 9, 2015 · Class II · Z-1123-2015: Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.
- Apr 14, 2011 · Not classified · Z-2425-2011: 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-2433-2011: 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-2447-2011: 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-2445-2011: 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-2421-2011: 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-2428-2011: 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-2422-2011: 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-2430-2011: 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-2444-2011: 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-2432-2011: 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-2441-2011: 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-2424-2011: 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-2431-2011: 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-2426-2011: 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-2435-2011: 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-2423-2011: 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-2438-2011: 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-2442-2011: 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-2446-2011: 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-2434-2011: 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-2427-2011: 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-2436-2011: 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-2440-2011: 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-2437-2011: 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-2443-2011: 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-2439-2011: 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-2429-2011: 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
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 Porous Plasma Spray (PPS) Ringloc®± Acetabular System is intended for uncemented use only.

Source page: https://510kreport.com/device/K093235
Methodology: https://510kreport.com/methodology