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510(k) Data Aggregation
(182 days)
IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
The Implex Radial Head Replacement System is indicated for:
• Cemented Use Only.
• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
-Joint destruction and/or subluxation.
-Resistance to conservative treatment.
• Primary replacement after fracture of the radial head.
• Symptomatic sequelae after radial head resection.
• Revision following failed radial head arthroplasty.
The Implex Radial Head Replacement System is a modular prosthesis consisting of a metallic head and a Hedrocel porous tantalum stem. The metallic head component is offered in three diameter options of 16, 21, and 26 mm. each with 4 head extension lengths. The articulating surface of the head component is offered in Co-Cr-Mo alloy. The stem component is offered in three cross sectional sizes of 7, 9, and 11 mm, with corresponding stem lengths of 23, 30, and 37 mm, respectively. All stem size options are compatible with all head size options. The Implex Radial Head Replacement System is a modular system, and the metallic head must be inter-operatively cemented to the Hedrocel stem using PMMA bone cement.
Acceptance Criteria and Study Details for Implex Radial Head Replacement System (K984290)
This submission describes the Implex Radial Head Replacement System, a modular prosthesis for radial head replacement. The acceptance criteria and the study that proves the device meets these criteria are outlined below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for equivalence) | Reported Device Performance |
|---|---|
| Mechanical Integrity: Sufficient strength and durability for its intended use. | "Performance testing of the cemented modular assembly was performed, and the results indicate that the assembly possesses a high degree of mechanical integrity." |
| Biocompatibility: Materials used are safe for implantation and do not elicit adverse reactions. | "Additionally, the Implex Radial Head is manufactured from materials with known performance characteristics (MAF #920) and properties which are typically used in total joint arthroplasty." |
| Substantial Equivalence: Device characteristics (materials, design, configuration, indications for use) are comparable to legally marketed predicate devices. | "A comparison of device characteristics (materials, design, configuration, and indications for use) included in this 510(k) Premarket Notification supports a substantial equivalence determination." |
2. Sample Size and Data Provenance
The provided 510(k) summary does not explicitly describe a clinical study in terms of sample size or data provenance (e.g., country of origin, retrospective or prospective) for assessing device performance in humans. The performance data mentioned refers to mechanical testing of the device itself, rather than patient data.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This 510(k) pertains to a medical device's mechanical and material properties and its substantial equivalence to predicate devices, not a diagnostic or prognostic algorithm requiring expert-established ground truth from clinical cases.
4. Adjudication Method
Not applicable, as no clinical study requiring adjudication of patient cases is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. No MRMC study was conducted or described in this 510(k) submission. The device is a surgical implant, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance
Not applicable. The "device" is a physical implant, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance evaluation in this 510(k) is based on:
- Mechanical Testing Results: For assessing the physical integrity of the cemented modular assembly.
- Material Science Data: For evaluating the known performance characteristics and properties of the materials used (referring to MAF #920).
- Comparison to Predicate Devices: For establishing substantial equivalence in terms of design, configuration, and indications for use.
8. Sample Size for the Training Set
Not applicable. There is no training set for an algorithm in this context. The data used for demonstrating performance are material specifications and mechanical test results of the physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there's no training set for an algorithm, there's no ground truth established in that sense. The "ground truth" for the device's characteristics relies on established engineering principles and material science.
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