(109 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 (Short Spindle and Anchor Plug) components are intended for uncemented use only.
The Compress® Seqmental Femoral Replacement System (Short Spindle and Anchor Plug) utilizes a spring-enhanced and stress-sharing design; to generate stress on the host bone which helps prevent bone atrophy and promotes bone growth. It is intended to be used in conjunction with a knee or hip implant. The device consists of the three main components, the Anchor Plug, Spindle, and the Taper Adapter.
This document is a 510(k) summary for the Compress® Segmental Femoral Replacement System (Short Spindle and Anchor Plug) by Biomet Manufacturing Corp. It is for a medical device, which typically relies on demonstrating substantial equivalence to a predicate device rather than on performance criteria established through clinical studies for new indications.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing | Successful mechanical testing indicated that the device is functional within its intended use and substantially equivalent to the predicate device in performance characteristics. |
| Technological Characteristics | The technological characteristics of the device are identical to the predicate device, including the spring-enhanced, stress-sharing design. |
| Dimensional Specifics | All dimensional specifics are similar to those of the predicate device. |
| Compatibility | Used in conjunction with the same hip or knee components as the predicate device. |
| Materials & Standards | Made from the same materials conforming to the same standards as the predicate device. |
Note: This submission relies on demonstrating substantial equivalence to a predicate device (Compress® Segmental Femoral Replacement System - K043547). The acceptance criteria are largely based on matching the design, materials, and mechanical performance of the predicate device. There are no specific quantifiable clinical performance metrics or acceptance thresholds provided beyond "successful mechanical testing" and "substantially equivalent."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of clinical testing for this 510(k). The evaluation was primarily based on non-clinical (mechanical) testing and a comparison to a predicate device.
- Data Provenance: The document explicitly states "Non-Clinical Testing: Successful mechanical testing on Compress® Segmental Femoral Replacement System (Short Spindle and Anchor Plug)..." This indicates laboratory-based testing rather than patient data. No country of origin is specified for this mechanical testing, and it is by nature retrospective (testing a finished product).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. As no clinical data was used to establish performance against a "ground truth" for the test set, no experts were needed for this purpose. The substantial equivalence was evaluated by the FDA based on the provided technical documentation and comparison to the predicate.
4. Adjudication Method for the Test Set
- Not applicable. There was no clinical test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." Therefore, no MRMC study was conducted or reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This is a physical orthopedic implant, not an algorithm or AI-driven device.
7. Type of Ground Truth Used
- Mechanical Performance and Design Equivalence: For the non-clinical testing, the "ground truth" would be the established performance characteristics and design specifications of the predicate device (K043547) and relevant industry standards for orthopedic implants. The new device's mechanical test results were compared against these.
8. Sample Size for the Training Set
- Not applicable. This is a physical orthopedic implant; there is no "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and the predicate device's specifications.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set, there is no ground truth to establish for it. The design and performance are validated against engineering principles and comparison to the existing predicate device.
§ 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.