RingLoc Constrained Liner

The RingLoc Constrained Liner is designed as an acetabular component for total hip arthroplasty, specifically to improve stability in patients at high risk of dislocation. This includes cases involving prior dislocations, significant bone loss, or soft tissue laxity. Its constrained design enhances congruity between the liner and metal shell, reducing lever-out or push-out forces to minimize dislocation risk during both primary and revision hip replacements.

The RingLoc Constrained Liner is intended for reusable surgical use in controlled clinical settings. It is not described as sterile in the provided data, so it must be handled and processed according to standard orthopedic implant protocols to ensure safety and sterility before reuse.

The device was cleared under the FDA’s 510(k) pathway in 1995 through the Traditional 510(k) process. It is classified under product code KWZ and reviewed by the Orthopedic (OR) Advisory Committee. The clearance was granted as substantially equivalent to a predicate device, with no explicit mention of MRI safety or additional certifications.

The provided data does not include explicit details on sizing variations or model-specific references for the RingLoc Constrained Liner. However, as a reusable acetabular component, it is designed to fit within standard orthopedic hip replacement systems, and sizing would typically be determined intraoperatively based on patient anatomy and surgical requirements.

The constrained design of the RingLoc Liner maximizes fixation strength between the liner and metal shell, creating a tighter interface that resists lever-out or push-out forces. This design is particularly beneficial for patients with complex anatomy, such as those with prior dislocations or bone loss, where standard unconstrained liners may not provide sufficient stability. The enhanced congruity reduces the risk of dislocation, a critical concern in high-risk hip arthroplasty cases.