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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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