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The MedCAD® AccuStride™ System is intended to be used as a surgical instrument to assist in preoperative planning and/or in guiding the marking of bone and/or guiding surgical instruments in non-acute, non-joint replacing osteotomies in the foot, ankle, and lower leg (tibia / fibula) for adult and pediatric patients 12 years of age and older. The MedCAD® AccuStride™ System surgical guides are intended for single use only. The MedCAD® AccuStride™ System surgical guides should only be used when the anatomic landmarks necessary for pre-operative planning can be clearly identified on the patient's radiographic images (i.e., CT).

The MedCAD® AccuStride™ System is a collection of two individual pieces of software and associated additive manufacturing equipment intended to provide a variety of outputs to support non-acute, non-joint replacing osteotomies in the foot, ankle, and lower leg (tibia / fibula). The system uses electronic medical images of the patient's anatomy or with input from the physician, to manipulate original patient images for planning and executing surgery. The patient specific outputs from the system includes anatomical models, surgical guides, and patient-specific case reports.

Following the MedCAD® Quality System and specific Work Instructions, trained employees utilize Commercial Off-The-Shelf (COTS) software to manipulate 3-D medical Computed Tomography (CT) images to create patient-specific physical and digital outputs. The process requires clinical input and review from the physician during planning and prior to delivery of the final outputs. The system is operated only by trained MedCAD employees, and the physician does not directly input information. The physician provides input for model manipulation and interactive feedback through viewing of digital models of system outputs that are modified by the engineer during the planning session.

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The Lincotek SportLinc Syndesmosis Device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Lincotek SportLinc Syndesmosis Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The SportLinc Syndesmosis Device is a sterile single-use device intended to stabilize syndesmotic trauma of the ankle. The subject implant assembly consists of UHMWPE suture tensioned between two low-profile titanium alloy buttons and is designed to complement plate fixation or to allow use as a standalone device. The button-suture assembly is assembled onto an inserter instrument and the pre-loaded assembly is packaged in a sterile single-use kit.

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The SF Push-in Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, knee, hip and shoulder. The SF Push-in Anchor is designed only to be inserted with the SupraFuser® Generator.

SF Push-in Anchor 1.6mm:
Hand/Wrist: Scapholunate 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 transfers, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
Elbow: Ulnar or Radial Collateral Ligament Reconstruction,
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction,
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction,
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair.

SF Push-in Anchor 2.3mm:
Hand/Wrist: Scapholunate 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 transfers, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Triangular Fibrocartilage Complex (TFCC)
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collament Ligament Reconstruction, Lateral epicondylitis repair,
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction,
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Achilles Tendon Repair, Bunionectomy,
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis,
Hip: Acetabular labral repair, capsular repair.

SF Push-in Anchor 3.0mm and 3.6mm:
Hand/Wrist: Scapholunate 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 transfers, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Triangular Fibrocartilage Complex (TFCC)
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, lateral epicondylitis repair,
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction,
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus and Varus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Metatarsal tendon repair, Bunionectomy,
Knee: Medial collateral ligament repair, lateral collateral ligament repair, patellar tendon repair, posterior oblique ligament repair, and iliotibial band tenodesis,
Hip: Acetabular labral repair, capsular repair.

The SF Push-in Anchor system consists of implantable anchors with 1.6, 2.3, 3.0 and 3.6mm diameter, an ultrasonic system, a sonotrode, dedicated anchor size specific drills and stoppers, a handpiece front cover, a guide with integrated wrench, and a set of reamers. The SF Push-in Anchors are delivered in a dedicated Implant Case to facilitate suture loading and suture handling during implantation. The SF Push-in Anchors are made of biocompatible and fully bioresorbable Poly-L-lactide-co-D,L-lactide. The SF Push-in Anchors are fully bioresorbable implants designed for soft tissue reattachment to bone by means of suture materials. The implantation process employs ultrasonic energy to liquefy the polymeric components of the Push-in Anchors at the interface with bone tissue. The liquid polymer flows into the marrow space of the surrounding cancellous bone, where it is immediately quenched and provides anchorage of the implant. The ultrasonic energy for the implantation of the Push-in Anchors is produced by the SupraFuser® ultrasonic generator and applied via the attached handpiece. The sonotrode is mounted on the handpiece. It transmits the ultrasonic vibrations to the Push-in Anchor. The drills and the stoppers are dedicated to be used with the Push-in Anchor of the respective size. The Geomax Reamer is used for the SF Push-in Anchors 1.6, 2.3 and 3.0 in cases of thick cortical bone or oblique insertion.

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Airlock® Ankle Plating System is indicated for arthrodesis of the ankle including tibiotalocalcaneal and tibiotalar joints, involving osteotomies of the distal tibia, talus, and calcaneus.

The system can be used in adult patients.

Airlock® Ankle Plating System is a range of implantable devices, made of titanium alloy, designed to treat ankle-related indications. Each implant is provided as a single-use sterile device.

The Airlock® Ankle Plating system range is constituted by 3 plates variants with holes, available in left and right option for anatomical adaptation. Screws for the fixation and the stabilization of the airlock ankle plates are available in 4 different variants (Locking polyaxial screws Ø4 or Ø4.7 and non-locking screws Ø4 or Ø4.7) and are available in lengths from 14 to 60mm.

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The Vortex5 Tailor's Bunion Correction System is indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the toes (such as 5th metatarsal osteotomies for the correction of Tailor's Bunion). The system may be used in both adults and adolescent patients (13-21 years of age).

The Vortex5 Tailor's Bunion Correction System is a single-use bone Correction device intended to be permanently implanted. The system consists of an additively manufactured titanium alloy plate and machined screws that provide correction for 5th metatarsal osteotomies for the correction of Tailor's Bunion.

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LOQTEQ® VA Proximal Humerus Plate 3.5 is indicated for fractures and fracture dislocations, osteotomies, and nonunions of the proximal humerus, particularly in osteopenic bone.

The subject device LOQTEQ® VA Proximal Humerus Short Plates are 21.5 mm wide at the proximal end, 12.4 mm wide along the shaft, and 3.2 mm thick. The shaft of each of the subject device short plates has one (1) oblong, non-locking screw hole, and 2, 3, 4, 5, or 6 VA (variable angle) locking 3.5 mm screw holes.

The subject device LOQTEQ® VA Proximal Humerus Long Plates are 21.5 mm wide at the proximal end, 12.8 mm wide along the shaft, and 3.9 mm thick. The shaft of each of the subject device long plates has one (1) oblong, non-locking screw hole, one (1) VA 3.5 mm screw hole, and 6, 8, 10, 12, or 14 LOQTEQ® 3.5 mm gliding locking-compression screw holes.

The subject device LOQTEQ® Cortical Screws have a standard cortical thread, 3.5 mm in diameter that tapers slightly at the tip. The heads of the screws are threaded to lock into the VA variable angle holes in the subject device plates. The screws are provided in overall lengths of 20 mm to 60 mm, in 2 mm increments.

The subject device LOQTEQ® Cancellous Screws have a standard cancellous thread, 4.0 mm thread diameter that tapers slightly at the tip. The heads of the screws are threaded to lock into the VA variable angle holes in the subject device plates. The screws are provided in overall lengths of 20 mm to 60 mm, in 2 mm increments.

The subject device plates and screws are manufactured from Ti-6Al-4V alloy conforming to ASTM F136 and ISO 5832-3.

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The QuikFix External Fixator: Knee-Spanning Pack is indicated for treatment of long bone fractures of the leg that require external fixation. Specifically, the system is intended for:

• Temporary stabilization of open or closed acute fractures with lower limb soft tissue injuries;
• Temporary stabilization of lower limb fractures in the context of polytrauma;
• Temporary stabilization of lower limbs after removal of total joint (knee, and ankle) arthroplasty for infection or other failure;
• Temporary stabilization of lower limb non-unions;
• Intra-operative temporary stabilization tool of the lower limb to assist with indirect reduction.

QuikFix External Fixator: Knee-Spanning Pack is intended for use in a non-weight bearing patient.

QuikFix External Fixator: Knee-Spanning Pack components are for single use only and are suitable for use in an MR environment.

QuikFix External Fixator: Knee-Spanning Pack includes various elements designed to build a fixator construct. The system includes fixation pins, clamps and rods.

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The Skeletal Dynamics Clavicle Fixation System is indicated for fractures, osteotomies, and non-unions of the Clavicle including osteopenic bone.

The Clavicle Fixation System features titanium (Ti 6Al-4V ELI) bone plates, offered in various sizes for the repair of the superior midshaft and superior lateral regions, as well as the anterior midshaft and anterior lateral areas. Included in the Clavicle Fixation system are titanium (Ti 6Al-4V ELI) and Cobalt-Chrome (CoCrMo) bone screws offered in 2.5mm, 2.7mm and 3.5mm diameters. Each plate is designed to accept specific compatible screw sizes, depending on the plate configuration. In addition, the system offers pegs that accept orthogonal screws, K-wires, and specialized instrumentation. The system is provided non-sterile and is sterilized at the user's facility.

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The CastleLoc Pectus Bar System is indicated for the treatment of Pectus Excavatum and other anterior chest deformities. It is intended to be used in pediatric (children and adolescents) and adult populations.

The CastleLoc Pectus Bar System is a thoracic support product that repairs the thoracic wall, using minimally invasive surgical techniques to elevate the ribs and sternum to correct a type of chest wall deformity called pectus excavatum. Recommended implantation time is 2-3 years but may vary based on surgeon preference and patient.

This system includes various sizes of straight and curved CastleLoc Pectus Bars. The appropriate bar is selected based on suitability for the patient body size. The CastleLoc Pectus Bar, and CastleLoc Pectus Stabilizer, Nut and CastleLoc Pectus Claw Fixator for fixing the CastleLoc Pectus Bar, are made of Ti-6Al-4V (ASTM F136).

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The DynaNail Mini and DynaNail Hybrid System are indicated for fracture fixation, osteotomies, reconstruction procedures, non-unions, and fusions of short bones, long bones, small fragments or large fragments in the foot and ankle.

The DynaNail Helix 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 such as short bones, long bones, and small or large fragments in the foot and ankle.

The DynaClip, DynaClip Forte, DynaClip Delta, DynaClip Quattro Bone Staples are indicated for

• Fracture, osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy.
• Fixation of small fragments of bone (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as the femur, fibula, and tibia in the lower extremities; the humerus, ulna, or radius in the upper extremities; the clavicle and ribs; and in flat bones such as the pelvis, scapula, and sternum.

The DynaNail Mini® Fusion System consists of the following components:

• Fusion Nail
  • DynaNail Mini® Fusion Nail
  • DynaNail Hybrid™ Fusion Nail
• End Cap
• Screws

The DynaNail Mini Fusion System is implanted using the DynaNail Mini Deployment Frame and Ancillary Surgical Instruments. The Fusion Nail is manufactured from nitinol and titanium alloy (Ti6Al- 4V ELI) and is available in multiple diameters and lengths. The End Cap is manufactured from titanium alloy (Ti 6Al-4V ELI). The Screws are manufactured from titanium alloy (Ti 6Al-4V ELI) and are available in a range of lengths.

The DynaNail Helix® Fixation System consists of the following components:

• DynaNail Helix Threaded Bone Fastener
• DynaNail Helix Washer

The DynaNail Helix Fixation System is implanted using the Ancillary Surgical Instruments. The DynaNail Helix Threaded Bone Fastener is manufactured from nickel titanium alloy and titanium alloy (Ti6Al-4V ELI) and is available in multiple lengths. The DynaNail Helix Washer is manufactured from titanium alloy (Ti6Al- 4V ELI).

The DynaClip®, DynaClip Forte®, DynaClip Delta®, DynaClip Quattro® Bone Staples are intended for internal fixation of small bones. The DynaClip Implant and Inserter comprise the DynaClip Device System. The DynaClip Implant is available in several different sizes and leg configurations.

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