Search Results

The Bionx Biodegradable, Threaded Distal Radius Screw is intended for use in the fixation of cancellous bone fractures in combination with appropriate postoperative cast immobilization. The device will specifically be indicated for use in open reduction and internal fixation of Frykman type I - IV dorsally displaced Colles fractures, osteotomies, and carpal fusions of the distal radius.

The Bionx Distal Radius Screw is a fully threaded, cylindrical, cannulated screw which is 4.5 mm in outer diameter. The screw threads secure the screw in the bone throughout the healing period, after which the screw gradually degrades and is completely absorbed by the body. Thus. there is no need to surgically remove the device.

The provided document, K974876, is a 510(k) summary for a medical device (Bionx Biodegradable, Threaded Distal Radius Screw) and does not contain detailed information about acceptance criteria or specific study results in the format requested.

General Information Based on the Document:

• Acceptance Criteria and Reported Device Performance: This document states that "Clinical testing and performance testing have also demonstrated the safety and effectiveness of the Bionx Distal Radius Screw for this intended use," and "The minor differences in the technical characteristics of the devices, such as differences in the configuration or materials, do not raise new questions of safety or effectiveness, as confirmed by clinical and mechanical testing." However, it does not provide specific metrics, acceptance thresholds, or reported device performance data in a table format. The approval is based on substantial equivalence to predicate devices, implying that its performance is implicitly accepted as similar to those legally marketed devices.

• Study That Proves the Device Meets Acceptance Criteria: The document refers to "Clinical testing and performance testing" as evidence of safety and effectiveness, and "mechanical testing" to confirm that material differences do not raise new questions. No specific study details (e.g., trial design, endpoints, methodology) are provided.

Specific Questions Not Answered by the Document:

The following information is not available in the provided 510(k) summary:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a medical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not explicitly stated, though "clinical testing" implies patient outcomes or physician assessment.
8. The sample size for the training set: Not applicable (not an AI device).
9. How the ground truth for the training set was established: Not applicable (not an AI device).

Summary of what is available from the document:

The 510(k) summary asserts that "clinical testing and performance testing have also demonstrated the safety and effectiveness of the Bionx Distal Radius Screw for this intended use." The basis for finding substantial equivalence rests on the device having similar intended use, principles of operation, and technical characteristics to predicate devices (Zimmer Herbert Bone Screw, Synthes Dorsal Distal Radius Plate System, Synthes Volar Distal Radius Plate, Zimmer Forte Distal Radius Plate, and Synthes Polypin). Minor differences in configuration or materials (poly-L-lactide polymer vs. titanium/stainless steel) were addressed by arguing that the biodegradable polymer has been used in other cleared devices and that "biocompatibility [of] all these materials has been established in the medical literature, and all of the materials possess sufficient strength for distal radius fixation." Mechanical testing was also cited to support the safety and effectiveness despite material differences.

Ask a specific question about this device