Search Results

OSSIOfiber® Threaded Trimmable Fixation Nails are indicated for maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts, of the upper extremity, fibula, knee, ankle and foot in the presence of appropriate brace and/or immobilization in adults and children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The OSSIOfiber® Threaded Trimmable Fixation Nails are threaded cannulated bone implants made of degradable poly (L-lactide-co-D, L-lactide) (PLDLA) reinforced with continuous mineral fibers. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made of minerals that are found in natural bone. As the OSSIOTiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery.

The OSSIOfiber® Threaded Trimmable Fixation Nails are supplied sterile, for single patient use only. The implants are available in several sizes and designs.

The OSSIOfiber® Threaded Trimmable Fixation Nails are designed to be used with commonly available orthopedic surqical tools such as ISO 9714 compatible instruments.

This document is a 510(k) premarket notification decision letter from the FDA regarding a medical device, the OSSIOfiber® Threaded Trimmable Fixation Nail. This type of document does not contain information about AI/ML device performance or the study designs for evaluating such performance.

The content focuses on:

• Device Classification: Class II, regulated under 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener).
• Predicate Devices: Identifying previously cleared devices (Inion FreedomScrew™, OSSIOfiber® Compression Screw, etc.) for comparison.
• Device Description: Material composition (degradable poly (L-lactide-co-D, L-lactide) reinforced with continuous mineral fibers), degradation properties, and sterile single-use nature.
• Indications for Use: Maintenance of alignment and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis, and bone grafts in upper extremity, fibula, knee, ankle, and foot for adults and children/adolescents.
• Non-Clinical Data: Mentions mechanical testing (pull-out, flexural bending, torsional strength, driving torque) and biocompatibility studies (based on ISO 10993) to demonstrate equivalence to predicate devices, especially regarding initial performance and after in-vitro degradation. It also mentions chemical characterization and toxicological risk assessment for pediatric use.
• Conclusion: The FDA determined the device is substantially equivalent to its predicate devices based on non-clinical testing.

Therefore, I cannot provide the requested information regarding acceptance criteria, AI/ML study design, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as these details are not present in the provided text. This document is a regulatory approval letter, not a clinical or technical study report.

Ask a specific question about this device