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The Smith & Nephew BIORAPTOR◊ Suture Anchor is indicated for the reattachment of soft tissue to bone for the following indications: **Hip:** - Hip Capsule Repair - Acetabular labrum reattachment/reconstruction **Shoulder:** - Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions - Acromioclavicular separation repairs - Deltoid repairs - Rotator cuff tear repairs - Biceps tenodesis **Foot and Ankle:** - Hallux valgus repairs - Medial or lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions - Midfoot reconstructions - Metatarsal ligament/tendon repairs/reconstructions - Bunionectomy **Elbow, Wrist, and Hand:** - Biceps tendon reattachment - Ulnar or radial collateral ligament reconstructions - Lateral epicondylitis repair **Knee:** - Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament - Patellar realignment and tendon repairs - Vastus medialis obliquous advancement - Iliotibial band tenodesis Smith & Nephew BIORAPTOR◊ Curved 2.3 PK Suture Anchors are indicated for the reattachment of soft tissue to bone for the following indications: **Shoulder:** - Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions - Acromioclavicular separation repairs - Deltoid repairs - Rotator cuff tear repairs - Biceps tenodesis **Foot and Ankle:** - Hallux valgus repairs - Medial or lateral instability repairs/reconstructions - Achilles tendon repairs/reconstructions - Midfoot reconstructions - Metatarsal ligament/tendon repairs/reconstructions - Bunionectomy **Elbow, Wrist, and Hand:** - Biceps tendon reattachment - Ulnar or radial collateral ligament reconstructions - Lateral epicondylitis repair **Knee:** - Extra-capsular repairs: - Medial collateral ligament - Lateral collateral ligament - Posterior oblique ligament - Patellar realignment and tendon repairs - Vastus medialis obliquous advancement - Iliotibial band tenodesis The Smith & Nephew BIORAPTOR◊ Suture Anchor is intended for the reattachment of soft tissue to bone. The Smith & Nephew BIORAPTOR◊ Curved 2.3 PK Suture Anchor is intended for the reattachment of soft tissue to bone.

The Smith & Nephew BIORAPTOR 2.3 PK and BIORAPTOR Curved 2.3 PK Suture Anchors are fixation devices intended to provide secure attachment of soft tissue to bone. The devices consist of a suture anchor with attached non-absorbable suture(s) preassembled to an insertion device. The BIORAPTOR Curved 2.3 PK Suture Anchors are preassembled to a flexible insertion device.

The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures. The CONMED Argo Knotless® Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

The CONMED Argo Knotless® Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10⁻⁶. The threaded anchor and the suture eyelet are manufactured of PolyEtherEtherKetone (PEEK) material. Each size features a single use driver, a threaded anchor, suture eyelet, a 1.0mm UHMWPE Hi-Fi™, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. A maximum of six (6) Hi-Fi #2 suture, or 1.3mm Hi-Fi ribbon suture, or (2) two limbs of Hi-Fi tape, or one (1) bioresorbable reinforced implant can be threaded through the eyelet. The repair sutures are then tensioned and cleated on the driver cleat, if deemed necessary by the surgeon. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

The PULLUP®, BT LOOP®, PULLUP® CLIP and PULLUP® TEX CLIP cortical fixation devices are indicated in adults for reconstruction of the anterior cruciate ligament. - PULLUP®, PULLUP® CLIP, PULLUP® TEX CLIP must be used with a Soft Tissue Transplant. - BT LOOP® must be used with a Bone Tendon Bone Transplant. The RIGIDLOOP™ T, RIGIDLOOP™ BTB, RIGIDLOOP™ Clip and RIGIDLOOP™ Suture Loop cortical fixation devices are indicated in adults for reconstruction of the anterior cruciate ligament. - RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ Suture Loop must be used with a Soft Tissue Transplant. - RIGIDLOOP™ BTB must be used with a Bone Tendon Bone Transplant.

- PULLUP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, and is designed to be used with a soft tissue graft. Standard and XL sizes. - BT LOOP®: comprises a titanium button-plate, and an adjustable nonabsorbable braided loop. The system is preloaded with traction and flip threads, as well as a temporary split suture, and is designed to be used with a bone-tendon-bone graft. It is assembled on a holder that can be mounted on the GraftTech® preparation station. Standard and XL sizes. - PULLUP® CLIP: comprises a titanium button-plate only, is designed to be used with a soft tissue graft, and can either be connected to another PULLUP® CLIP button-plate by using the PULLUP® TEX CLIP nonabsorbable braided loop, or can be connected to another PULLUP® device. Standard and XL sizes. - PULLUP® TEX CLIP: Comprises a nonabsorbable braided loop. One size only. Standard models are used for cortical tunnels with a diameter of 4.5 mm; XL models are used for cortical tunnels with a diameter between 5 and 10 mm. The implants are supplied sterile, individually packaged, ready to use. The PULLUP®, PULLUP® CLIP, BT LOOP® and PULLUP® TEX CLIP devices are also sold under the trade names RIGIDLOOP™ T, RIGIDLOOP™ Clip, RIGIDLOOP™ BTB and RIGIDLOOP™ Suture Loop respectively.

Components of the Signature Orthopaedics range of soft tissue fixation devices are intended to reattach ligament, tendon or soft tissue to bone. Specifically, the BI-ON Screw and Anchor, BI-ON Bio-screw and Bio-anchor, Vector Knotted, ATOK, Vortex Anchor, Dynaloc Anchor and Shoulder Suture Anchor are indicated for use in the shoulder, including: Shoulder - Capsular stabilization - Bankart Repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions - Acromioclavicular separation repairs - Deltoid repairs - Rotator cuff tear repairs - Biceps tenodesis

The Shoulder Soft Tissue Anchor System consists of a range of implants for soft tissue fixation to bone in the shoulder joint. The soft tissue anchors are manufactured from PEEK OPTIMA LT1 (ASTM F2026) or a PEEK/Hydroxyapatite composite and are available as knotted and knotless variants. Several of the soft tissue anchor variants are supplied preloaded with sutures and preassembled onto a driver. The UHMWPE (HS fibre) sutures are finished devices externally supplied by RiverPoint Medical and previously cleared through 510(k) K10006. All components are intended for single use only. The following variants are included in the range of Shoulder Soft Tissue Anchors: - Turbine Anchor - Mini Incision Anchor - Turbine OP Anchor - Vortex Anchor - Vector Anchor - DynaLoc Anchor - BI-ON Bio Anchor - Arthroscopic Transosseous Knotless (ATOK) Anchor

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: • 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 Reconstruction • Hand/Wrist: Scapholunate 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 transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) • 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, Joint Capsule Closure • Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The Arthrex FiberTak Suture Anchor is an all-suture knotless anchor intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. The anchor is constructed from a hollow braid sheath made of polyester yarns with Arthrex suture components assembled to the sheath. The suture components include a repair suture and a passing suture which are braided polyester sutures made of ultra-high molecular weight polyethylene (UHMWPE) where the suture may also include nylon yarns. The anchor is preloaded on a disposable inserter and is provided sterile (Ethylene Oxide), single-use, and is packaged in a 5-pack.

The Arthrex Tightrope Soft Button, RT implant is intended to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACLI PCL repair and reconstruction MCL, POL, LCL repair and reconstruction; ITB and PTR repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction for the adult patient population.

The proposed Arthrex TightRope Soft Button, RT is comprised of a suture loop, suture button and passing sutures. The suture loop and passing sutures are braided nonabsorbable surgical sutures.