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TriMed Ulnar Osteotomy Plates are indicated for use in osteotomy procedures of the Ulna.

TriMed Ulnar Osteosystem System includes plates and screws indicated for osteotomies of the ulna. TriMed Ulnar Osteotomy System plates and screws are manufactured from medical grade stainless steel. Ulnar Osteotomy Compression Plates accept 3.2mm locking and non-locking screws. The lag screw hole in the plate accepts a 3.2mm lag screw that helps achieve additional compression across the osteotomy site.

The Rialto™ SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The subject RIALTO™ SI Fusion System consists of cannulated devices available in various lengths, used to provide stabilization when fusion of the sacroiliac joint is desired. Autograft and/or allograft may be placed in conjunction with the RIALTO™ SI Fusion System. The RIALTO Screws are made using Titanium Alloy and are 40mm- 60mm in length with a diameter of 12mm. This device may be implanted via a minimally invasive approach using fluoroscopy or navigated instruments compatible with Medtronic StealthStation® and IPC® POWEREASE®.

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 PediFlex™ Flexible Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow, or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric and small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.

The PediFlex™ Flexible Nail System includes stainless steel and titanium flexible nails, interlocking clamps, clamp screws and end caps for the application of aiding bone fracture repair and healing. All the implants are MR conditional. The system is implanted using Class II and Class I exempt surgical instruments. The PediFlex™ flexible nails are provided in 316L stainless steel and titanium alloy (Ti-6Al-4V). The 316L stainless steel flexible nails are available in diameters ranging from 1.5 mm to 4.0 mm in increments of 0.5 mm. The titanium alloy (Ti-6Al-4V) flexible nails are available in diameters ranging from 1.5 mm to 4.5 mm in increments of 0.5 mm. The PediFlex™ interlocking clamps are designed to hold flexible nails in place after insertion by clamping the nail and being fixed to the bone. The use of the interlocking clamps is optional. The interlocking clamps are manufactured from both 316L stainless steel and titanium alloy (Ti-6Al-4V) materials. The 316L stainless steel interlocking clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm and 4.0 mm which are to be used with 316L stainless steel flexible nails in diameters of 3.0 mm, 3.5 mm and 4.0 mm. The 316L stainless steel clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The titanium alloy (Ti-6Al-4V) interlocking clamps are available in right and left configurations, in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm which are to be used with titanium alloy (Ti-6Al-4V) flexible nails in diameters of 3.0 mm, 3.5 mm, 4.0 mm and 4.5 mm. The titanium alloy (Ti-6Al- 4V) clamp screws are available in 15 mm, 25 mm, and 35 mm in length. The material of the clamp must match the material of the nail and screw in the surgery. The PediFlex™ end caps are designed to affix to the exposed nail tip to help prevent soft tissue irritation. The use of the end cap is optional. They are not a structural element and impart no additional strength to the construct. The subject end caps are manufactured in titanium alloy (Ti-6Al-4V) and are available in diameters ranging from 1.5mm to 4.5mm with 0.5mm increments which are to be used with titanium alloy (Ti-6Al-4V) flexible nails in diameters ranging from 1.5mm to 4.5mm with 0.5mm increments. The material of the end cap must match the material of the nail used in the surgery. The flexible nails, interlocking clamps, clamp screws and end caps in PediFlex™ Flexible Nail System are offered both sterile and non-sterile. All other Class II implants and instruments of the PediFlex™ Flexible Nail System are offered non-sterile to be sterilized by the end-user.

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-FiTM, 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 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 Eleganz™ Fusion Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies. The screws are not intended for interference or soft tissue fixation.

The EleganzTM Fusion Screw System includes screws for bone fixation and a set of instruments used for screw site preparation and delivery. The device is offered in two non-sterile trays that contain the screw, Kirschner wire, bone preparation instrumentation and a driver. The screws and Kirschner wires are used to stabilize a fracture, osteotomy site, or joint so that healing and fusion may occur which achieves its intended function. The screws are available in solid and cannulated versions and are made from Ti6Al4V alloy. They range from 8-50 mm in length. The outer diameter is tapered, varying from 2.5 mm at the tail to 2.0 mm (solid) or 2.25 mm (cannulated) at the tip. The Kirschner wires are 316 stainless steel. The instrumentation includes a drill, driver handle, driver bit, depth gauge / countersink, Kirschner wire, and ball and socket reamers. The drills and driver components are cannulated. The drills are offered in two lengths. The driver handle is used with the driver bit to insert the screw as well as with the drill for hand drilling. The depth gauge measures the Kirschner wire to determine its depth in the bone. The countersink has cutting flutes for easier entry into the intramedullary canal. The ball and socket reamers create a spherical radius on joint surfaces for better bony fusion.

The Impact PEEK Union Nail System is indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

The Impact PEEK Union Nail System contains 3.0mm - 4.5mm diameter, 50mm long pins manufactured from HA Enhanced PEEK (ASTM F2026). The implants are designed with strategically placed ridges to improve initial stability and cannulated structure to simplify insertion over a k-wire. Additionally, it was designed to include tantalum pins to ensure optimal imaging visibility for device placement accuracy.

The LORRAINE 2.5/3.5mm Distal Humerus System is indicated for intra-articular or extra-articular fractures of the distal humerus, supracondylar fractures, osteotomies, and non-unions. Longer plates may be used for distal humerus fractures with diaphyseal extension.

The Bonebridge Osteosynthesis Plating System is intended for treating fractures of various bones. It consists of plates, locking and non-locking screws for fixation and corresponding instruments. The plating system is further subdivided into variants/types based on the anatomical location of the fracture. The subject LORRAINE 2.5/3.5mm Distal Humerus System is a variant of the Bonebridge Osteosynthesis Plating System. The plates are primarily manufactured from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139) and include Titanium Inlay Clips (TICs) made from pure titanium (ASTM F67 or ISO 5832-2). The screws are manufactured entirely from stainless steel (ISO 5832-1, ASTM F138, or ASTM F139). All materials used are biocompatible, corrosion-resistant and nontoxic in a biological environment. Surgical instruments are made of stainless steel (ASTM F899, ISO 7153-1, ISO 5832-1, and ASTM F138/139), medical grade PEEK, medical grade EPDM terpolymer, or medical grade silicone. All plates are sterilized with gamma irradiation and delivered sterile. Screws and instruments are delivered non-sterile. Devices supplied in a non-sterile condition must be cleaned and steam sterilized prior to surgical use. Non-clinical testing has demonstrated the implants are MR Conditional.

The Omnia Medical PsiF DNA™ System is intended for sacroiliac joint fusion for conditions including degenerative sacroiliitis and sacroiliac joint disruptions. The PsiF DNA™ may be implanted via a transverse or inline approach. When PsiF DNA™ is implanted inline, it must be used with a PsiF DNA™ screw implanted transversely across the same sacroiliac joint.

The Omnia Medical PsiF DNA™ System consists of screws and washers manufactured from Ti-6Al-4V ELI per ASTM F3001 and ASTM F136, respectively. The screws are available in one diameter and a variety of lengths to accommodate varying patient anatomy. The system includes instrumentation for implantation that is manufactured from surgical grade stainless steel or aluminum. During the procedure, the implant is inserted through the ilium to pierce its medial cortex, across the sacroiliac joint and into the sacrum to pierce its lateral cortex, and bone graft material is placed in the barrel of the implant to facilitate additional bone incorporation after surgery. The implants and instruments are provided in two surgical kit options. In one kit, the implants and instruments are provided non-sterile and sterilized by the end user. In the other kit, the implants and instruments are single-use and provided sterile.