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WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surqical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.

The WasherCap™ Fixation System is an implantable non-active device consisting of three components: the washer, the cap, and the screw. All components building the WasherCap™ Fixation System are made of high-quality biocompatible materials, with a long-existence use in terms of human safety and patient's clinical performance. The Washer and the Cap are made from non-degradable organic thermoplastic polymer biomaterial, so-called Polietheretherketone (PEEK by Invibio™ Biomaterial Solutions in accordance with ASTM 2026) and the Screw is made from implantable degree Titanium Alloy (Ti-6Al- 4V ELI) in accordance with ISO 5832-3 and ASTM F136 standards. To achieve correct implantation and use of the device requires specific accessories: WasherCap™ Instrument Set. The required accessories are product- specific reusable surgical instruments that have been designed for the implantation of the WasherCap™ Fixation System. Use of the WasherCap™ Instrument Set will ensure the surgical procedure, and the use of the WasherCap™ Fixation System are carried out in an appropriate manner.

WasherCap™ Mini Fixation System is intended for fixation of suture/tape (soft tissue) to bone in the shoulder, knee and hand/wrist, in skeletally mature pediatric and adult patients for the following procedures: • Knee: - Meniscal root repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes. - Meniscal transplant: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes. - ACL/PCL Repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes. - ACL Reconstruction: only with WasherCap™ Mini Fixation System 4.5mm size and using 2 nonabsorbable UHMWPE 1.4mm tapes or 1 non-absorbable UHMWPE 2.2mm tape. • Shoulder: - Rotator Cuff Repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes. • Hand/Wrist: - Triangular fibrocartilage complex (TFCC): only with WasherCap™ Mini Fixation System 3.5mm size and using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.

The WasherCap™ Mini Fixation System consists of an implantable device, a handled inserter, a handled screwdriver, a drill guide, a drill bit and a suture threader. The WasherCap™ Mini implantable device is pre-loaded on the handled inserter with the suture threader. The drill guide and the drill bit should be used to perform a drilling guided specifically to the angulation necessary to create the bone socket where the screw of the implant should be located. The suture/tape is passed through the cap with the suture threader and the screw is threaded with the handled screwdriver, setting the tension of the suture/tape. The WasherCap™ Mini Fixation System is provided sterile and individually packaged. All components are for single use only. The WasherCap™ Mini Fixation System is available in different sizes and should be implanted following the corresponding surgical procedure.