HS Fiber

HS Fiber® is a non-absorbable surgical suture made from ultra-high molecular weight polyethylene (UHMWPE) braided strands, available with or without pre-attached needles. It is indicated for soft tissue injury and reconstruction where ligation or approximation is required, and for fixating allograft tissues such as in ACL repairs.

The device is technologically identical to the predicate device K231163, composed of the same UHMWPE material, manufactured using the same processes, sterilized using the same methods, and tested to the same USP performance requirements for length, tensile strength, and needle attachment. The only difference is in labeling—a slight rewording of the Indications for Use statement and addition of contraindications outside the cleared scope.

Finished goods testing is performed per USP performance requirements for length, tensile strength, and needle attachment.

The device has identical intended use, principles of operation, and technical characteristics to the predicate device. The changes are limited to labeling updates that do not alter the device's safety or effectiveness profile. Since no modifications were made to materials, sterilization, manufacturing processes, or testing procedures, and the labeling differences involve only rewording of existing indications and addition of contraindications outside the original scope, no new safety or effectiveness questions are raised. Therefore, the device is substantially equivalent.