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The Tigon Medical Knotless and Dual Javelin All-Suture Anchors are an extension to the Tigon Medical All-Suture Anchor line cleared in K242529 (December 20, 2024). The Tigon Medical Javelin All-Suture Anchors are intended for the reattachment of soft tissue to bone for the following indications:

• Elbow: Biceps Tendon Reattachment. Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair
• Hand/Wrist: Scaphulolunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/Reconstruction of Collateral Ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP Joints for all Digits, Digital Tendon Repair
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The Tigon Medical Knotless and Dual Javelin All-Suture Anchors are an extension to the Tigon Medical All-Suture Anchor line cleared in K242529 (December 20, 2024). The Knotless Javelin All-Suture Anchor serves as a soft tissue fixation device that enhances surgical efficiency by eliminating the need for knot tying. The Dual Javelin All-Suture Anchor enhances the line by creating a double sock, knotless construct, eliminating the steps of tying a knot and passing suture through tissue. The devices are UHMWPE per ASTM F2848, permanent, soft-tissue fixation devices provided EtO sterilized and preloaded on an inserter. The anchors, available in 1.6 mm, 2.3 mm, and 2.6 mm sizes, come in various load configurations consisting of one or more working sutures, USP 2 suture cable, 1.5 mm suture tape, USP 5 suture cable, and/or 2 mm suture tape. The anchors can be implanted via self-punching or drilling and are intended to deploy under the cortical layer of the bone. The inserters can be reprocessed after use and are made from stainless steel. The device is intended for single-use in a surgical setting.

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