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The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is indicated to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is a combination of two FDAcleared Surgicraft Products, the Surgicraft LOCKDOWN Mesh (K072370) and the Surgicraft LOCKDOWN Screw (K080447). The new product for this indication is designated as the LOCKDOWN™ Acromioclavicular (AC) device and will have a new indication to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions. It is not intended that the Surgicraft LOCKDOWN™ Acromioclavicular (AC) device be used as the sole means of reconstructing a chronic acromioclavicular joint dislocation. The Surgicraft LOCKDOWN Mesh device is a woven mesh 11mm wide by 4 to 20 cm in length with loops at both ends. The Surgical Mesh is made from braided Polyethyleneterephthalate (Polyester) fibers (PET). The Surgicraft LOCKDOWN Screw is manufactured from stainless steel and titanium alloy. The self-tapping 3.5 mm screws are available in lengths from 14- 40 mm in 1 mm increments. The washers have a hole with an inner diameter of 4.2 mm and an outer diameter ranging from 7 to 9 mm in 1 mm increments. The Surgicraft LOCKDOWN™ Acromioclavicular (AC) device is provided sterile.

The Surgcraft Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery. The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.

The Surgicraft Surgical Mesh System consists of a series of specialized shapes of surgical mesh made from commercially available polyester suture fibers. All sizes incorporate regions of reinforced holes to assist secure anchoring of the mesh to tissue. The devices are available in a variety of different shapes and sizes to suit the individual pathology and anatomical conditions of the patient.

The Surgicraft Screw Fixation System and is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Acromio-Clavicular Separation Repair, Capsular Shift/Capsulolabral Reconstruction, Biceps Tenodesis, Deltoid Repair. Foot and Ankle: Medial Instability Repair/Reconstruction, Lateral Instability Repair/Reconstruction, Achilles Tendon Repair/Reconstruction, Midfoot Reconstruction, Hallux Valgus Reconstruction. Elbow. Wrist. Hand: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Biceps Tendon Reattachment. Knee: Extra Capsular Repairs - Medial Collateral Ligament, Lateral Collateral Ligament, Posterior Oblique Ligament, Illiotibial Band Tenodesis, Patellar Tendon Repair. Pelvis: Bladder Neck Suspension Procedures. Single patient use only

The Surgicraft Screw Fixation System is manufactured from stainless steel and titanium. The self-tapping 3.5 mm screws are available in lengths from 20- 40 mm in 1 mm increments. The washers have an inner hole diameter of 4.2 mm and an outer diameter ranging from 7 to 9 mm in 1 mm increments.

The STALIFTM TT Intervertebral Body Fusion System is indicated for use with autogenous bonc graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The STALIFTM TT is a stand alone system intended to be used with the bone screws provided and requires no additional supplementary fixation systems. The STALIFTM TT system may be used with bone grafting material (autograft only).

The Surgicraft STALIF"M TT is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws and is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIFTM TT is similar to that of the vertebral body endplate with a central cavity than can be packed with bone graft (autograft). The STALIFTMTT IBF System consists of varying sizes to include different widths, heights and hole positions to accommodate individual pathology and anatomical conditions.

The STALIF C is intended to be used as an intervertebral body fusion cage as a stand alone system used with the bone screws provided and requires no additional supplementary fixation systems. It is inserted between the vertebral bodies into the disc space from levels C2 to T1 for the treatment of cervical degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The device system is designed for use with autograft bone to facilitate fusion. STALIFTM C is intended to be used at one level. The cervical cage is to be used in a skeletally mature patient who has had six weeks of non-operative treatment prior to implantation of the cage.

STALIFTM C is a radiolucent intervertebral body fusion device and unicortical cancellous bone screws and is intended to be used as an IBF cage without supplementary fixation. The cross section profile of the STALIFTM C is similar to that of the vertebral body endplate with a central cavity that can be packed with autograft. STALIFTM C is manufactured from PEEK-Optimad LTI.

The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is intended for use as a vertebral body replacement or partial replacement in the thoracolumbar spine (from T9 to L5). The STALIF™ TT device may be used with bone graft.

The Surgicraft STALIF™ TT is a radiolucent vertebral body replacement device used in coniunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion.

The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction by tumor or fracture leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T9 to L5). The STALIF ™ TT device is intended for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the STALIF TT device, include but are not limited to, DePuy AcroMed titanium plate or rod systems (e.g., Kaneda SR, University Plate, M2, Isola, VSP, Moss Miami, TiMx, Monarch and Profile).

The Surgicraft STALIFTM TT is a radiolucent vertebral body replacement device used in conjunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion. Material: PEEK-OPTIMA LT1

Surgical stabilization and fusion of the cervical spine for the correction of spinal deficiencies. Indications For Use: 1. Spinal deformity 2. Spinal tumors 3. Spinal fracture 4. Dislocations 5. Subluxations 6. Spondylolisthesis

The TITANIUM HARTSHILL SYSTEM consists of the following items: REF SIZE HTR 4025 - 4mm x 25mm HTR 4035 - 4mm x 35mm HTR 4045 - 4mm x 45mm HTR 4065 - 4mm x 65mm HTR 4075 - 4mm x 75mm HTR 4085 - 4mm x 85mm Surgical instruments designed to implant the device are also available. Fixation Wire and Braided Fixation Cable are available in both stainless steel and titanium alloy for use with the appropriate implant type.

Fixation of bone fragments 1. Bone fractures 2. Bone reconstructions 3. Bone traction

Not Found

Surgical stabilization to assist bony fusion of the cervical spine and cervical occipital junction. Indications For Use: 1. Degenerative disk disease of the cervical vertebrae (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) 2. spondylolisthesis of the cervical vertebrae 3. Spinal stenosis of the cervical vertebrae 4. Atlanto/axial fracture with instability 5. Cervical-occipital dislocation 6. Revision of previous cervical spine surgery 7. Tumors

The Ransford Cervical Fixation System consists of various loops (in stainless steel and titanium, with different angles and lengths), stainless steel and titanium cross links, and surgical instruments. These implants are designed for use with annealed stainless steel wire 0.9mm diameter (20swg) or multi-filament braided titanium alloy (6A),4V) cable, 0.045 inch (1.1mm) diameter, 19 inches long with a 3 inch, soft, pure titanium mono-filament lead wire. The system is based on sublaminar wires and contoured rods placed posteriorly.