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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.
   M2a™ 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.

All devices are metallic, full-hemisphere, acetabular shell components. Each shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery.

The provided 510(k) summary for the Ranawat Burstein® Acetabular Components, Full Hemisphere Acetabular Components, Quadrant Sparing Shells, and McLaughlin™ +5 Acetabular System does not include acceptance criteria or a study demonstrating device performance.

This document is a premarket notification (510(k)) for a medical device. For many devices, especially those considered substantially equivalent to already marketed predicate devices, the FDA often does not require new clinical or non-clinical testing if the new device has similar technological characteristics and intended use to the predicate. This seems to be the case here.

The document explicitly states under "Clinical and Non-Clinical Testing": "None provided". This indicates that no new studies were conducted or provided to demonstrate performance against specific acceptance criteria for this 510(k) submission. Instead, the submission relies on the substantial equivalence to previously cleared devices.

Therefore, I cannot provide the requested information, as it is not present in the provided text.

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