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The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet provide tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet are cannulated, sterile, single-use bone screws made of an absorbable homopolymer derived from Poly (L-Lactic Acid). Two sizes will be available for the device, 8 x 35mm and 8 x 40mm. The BioScrew® XtraLok® 8 x 35mm and 8 x 40mm, violet, differ from the existing Linvatec BioScrew® XtraLok™ in that the major diameter is smaller. The violet colorant contained in this device, has been cleared for this product code and intended use by the FDA via color petition 8C0255 dated January 28, 1998. The modification does not affect the device's intended use, fundamental scientific technology or performance specifications.

This document is a 510(k) submission summary for a medical device called BioScrew® XtraLok®. It seeks to establish substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study proving that the device meets such criteria. It is a regulatory submission for premarket notification rather than a performance study report.

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The BioScrew® XtraLok™ interference screw provides tibial interference fixation of a soft tissue graft for ACL and PCL reconstruction.

The BioScrew Xtralok™ is a cannulated, sterile, single-use bone screw made of an absorbable homopolymer derived from Poly (L-Lactic Acid).

The BioScrew XtraLok will be available in 6 sizes: 9, 10, and 11mm diameters by 35 or 40mm lengths. The proximal face is angled from the axis of the BioScrew, and the proximal region of the threaded body tapers to a larger diameter.

This document is a 510(k) summary for the BioScrew XtraLok Bioabsorbable Interference Screw. It describes the device and its intended use, but it does not contain acceptance criteria or the study that proves the device meets specific acceptance criteria. This type of regulatory submission (510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance data against specific acceptance criteria.

Therefore, I cannot fulfill your request for the detailed table and information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth, as this information is not present in the provided text. The document states that "The BioScrew XtraLok interference screw does not raise any new issues of safety or effectiveness when compared to this predicate device," which is the basis of its
510(k) clearance, not a study proving its performance against acceptance criteria.

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