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TheraMicro TeKBrace Knotless Anchors are intended for use in the following applications:

Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction.

Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus reconstruction, Midfoot reconstruction, Metatarsal Ligament/Tendon Repair, and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair (4.75- 5.5 Only), Medial collateral and Lateral collateral ligament repair, Patellar tendon repair and Posterior oblique ligament repair, Extra Capsular Reconstruction, Illiotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair. Quadriceps Tendon Repair (4.75 Only), Meniscal Root Repair (4.75 Only), Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 only), MPFL Repair/Reconstruction (3.9 Only)

Hand and Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament and Ulnar collateral ligament reconstruction.

Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 - 5.5 mm only), and Proximal Hamstring Repair (4.75 - 5.5 only).

The TeKBrace Knotless Anchors are part of the TeKBrace System which is intended for the fixation of soft tissue to bone. The TekBrace Knotless Anchor consists of a two-piece anchor manufactured from polyetherether-ketone (PEEK) and is available in three sizes (3.9mm, 4.75mm and 5.5mm). The knotless anchor is a sterile two-component suture anchor comprised of an eyelet and hollow anchor body. The TeKBrace Knotless Anchor will be provided in a kit also containing the TeKBrace Solo Soft Tissue Reinforcement Device previously cleared in K251063. Additionally, anchors and eyelets may be provided packaged separately for convenience. All devices are single-use only and provided sterile via gamma irradiation.

There are two kit configurations including the TekBrace Knotless Anchor and TekBrace Solo Devices. In these configurations the TekBrace Solo acts as the suture when compared to predicate devices with an anchor / suture construct. The anchor may be provided preloaded with TeKBrace Solo on an inserter or the anchor may be provided not pre-loaded, but in the same packaging as the TeKBrace Solo Device. Both configurations include the instruments required for the procedure.

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