(258 days)
Cemented or non-cemented total hip replacement in cases of
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Correction of functional deformity
- Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
- 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.
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.