(225 days)
Indications:
- Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Tumor resections.
- Revision of previously failed total joint arthroplasty
- Trauma
The Compress Segmental Femoral Replacement System components are intended for uncemented use only.
The ComPreSs® Segmental Femoral Replacement System consists of three main components, the anchor plug, the spindle assembly, and the intercalary segment. The Anchor Plug is embedded within the medullary canal, the Spindle Assembly attaches to the Anchor Plug and is compressed against the bone / implant interface at the osteotomy site. The Intercalary Segment attaches to the Spindle Assembly, and completes the Femoral Stem Component.
This system is intended for use in both the proximal and distal femur.
This document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. Instead, it is a 510(k) summary for a medical device (ComPreSs® Segmental Femoral Replacement System) seeking substantial equivalence to legally marketed predicate devices.
The key points from the provided text are:
- Device: ComPreSs® Segmental Femoral Replacement System
- Applicant: Biomet Manufacturing Corp.
- Date: August 5, 2005 (with a correction letter dated April 23, 2009)
- Purpose of Submission: To demonstrate substantial equivalence to predicate devices, not to prove specific performance against acceptance criteria in a new study.
- Basis for Equivalence: The submission states that "All components of this system are identical in material, processing, function, and design to their respective predicate components."
- Non-clinical Testing: "The engineering rationale with the attached literature and mechanical test reports support the claim for substantial equivalence to the predicate devices." (No specific acceptance criteria or performance numbers are given here).
- Clinical Testing: "Clinical testing in support of the predicate Compress® Distal Femoral Replacement System is sufficient to ensure safety and efficacy. No further clinical testing is necessary to support the claim for substantial equivalence to the predicate devices." This explicitly states that no new clinical study was performed for this specific device to establish novel acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, adjudication methods, or MRMC studies is not present in the provided text. The document focuses on demonstrating equivalence through comparison to existing, approved devices and their past testing, rather than presenting new performance data for the subject device against defined acceptance metrics.
§ 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.