# K132539: Ring-Lok Modular Bipolar System

- Pathway: 510(k) (Traditional)
- Applicant: Implants International, Ltd.
- Decided: Feb 7, 2014 after 178 days
- Product code: KWY (Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953510 (1995). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091967: Medacta Bipolar Head, Medacta International S.A. (2010) Summary page 2.
- K082705: Biopro Bipolar Head, Models 18130-18152, Biopro, Inc. (2008) Summary page 2.

## Indications for use
The Ring-Lok Th Modular Si-Polar System is intended for use in combination with other previously cleared femoral components including the Rig-Fixtm Hip Stem (K0721 01), C-fit Performs (K(923898) or the Stability Hip Stem (K(91 5787 and K(934457) for uncemented primary or revision hemi-arthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate: * Femoral neck and trochanteric fractures of the proximal femur * Osteonecrosis of the femoral head * Revision procedures where other treatments or devices or these indications; have failed.

Source page: https://510kreport.com/device/K132539
Methodology: https://510kreport.com/methodology