(91 days)
The CONSERVE® Plus HA Acetabul: r Shells are indicated for use in total hip arthroplast! for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- non-inflammatory degenerative joint disease such as osteoarthritis, avascular 1. necrosis, ankylosis, protrusio ac tabuli, and painful hip dysplasia;
-
- inflammatory degenerative joint disease such as rheumatoid arthritis;
- correction of functional deformi y; and, 3.
-
- revision procedures where other treatments or devices have failed
The CONSERVE® Plus HA Acetabular Shells are intended for single patient use only.
A Hydroxylapetite (HA) coating is being a lded to the following previously cleared CONSERVE® Shells: CONSERVE® Plus Thin Shell, CONSERVE® Plus Spiked Shell, CONSERVE® Total SuperFix Shell, CONSERVE® Plus Thick & hell
{
"1. A table of acceptance criteria and the reported device performance": "The provided document is a 510(k) summary for a medical device, the CONSERVE® Plus HA Acetabular Shells. It states that the device is \"substantially equivalent\" to previously cleared predicate devices. Therefore, specific acceptance criteria and detailed device performance metrics (e.g., in a table format) that would typically be found in a clinical trial report are not present. The basis for acceptance is essentially the demonstration of substantial equivalence to existing devices.",
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "This document does not describe a study involving a test set, human subjects, or data provenance in the context of performance evaluation. The substantial equivalence argument relies on \"materials data, and testing results\" but does not specify sample sizes for these tests, nor their origin or type (retrospective/prospective)."
}
§ 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.