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The Osteotomy Truss System (OTS) is intended to be used for internal bone fixation for bone fractures or osteotomies in the foot, such as: - Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus - . Opening wedge of Medial Cuneiform or Cotton osteotomies - Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) - Metatarsal/Cuneiform osteotomies - . Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus) - . Hindfoot osteotomies The device is intended for use with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.

The Osteotomy Truss System (OTS) consists of five implant designs in a variety of footprints and implant height options to accommodate the patient's anatomy. It is intended to be used with supplemental fixation. The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.

The Anterior Spine Truss System - Stand Alone (ASTS-SA) Interbody Fusion Device is a stand-alone interbody fusion device indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbosacral spine at one or two contiguous disc levels. Each interbody fusion device is intended to be used with three titanium alloy screws or anchors which accompany the implant. Hyperlordotic implants (>20° lordosis) are intended to be used with supplemental fixation (e.g. posterior fixation). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. ASTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the lumbosacral spine and are placed via an anterior approach at the L2 to S1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). When using the ASTS-SA Interbody with fixation anchors, the device must be used with supplemental fixation.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws or anchors are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.

The 4WEB Medical Ankle Truss System (ATS) is for use as an accessory to the Stryker T2 Ankle Arthrodesis Nail or the Stryker Valor Hindfoot Fusion Nail as part of a tibiotalocalcaneal fusion construct in a salvage procedure following failed ankle arthrodesis or failed ankle arthroplasty for patients at risk for loss of limb. The ATS is not intended for standalone use. The anatomical landmarks necessary for the design and creation of ATS devices that are patient matched must be present and identifiable on appropriate radiography scans. The ATS is intended for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.

The 4WEB Medical Ankle Truss System (ATS) is a permanently implanted device intended to provide mechanical support as an accessory to a tibiotalocalcaneal nail intended to fuse the tibiotalocalcaneal joint in a salvage procedure following a failed ankle arthrodesis or a failed ankle arthroplasty for patients at risk for loss of limb. ATS devices are titanium alloy (Ti6Al4V) structures in spherical or cuboidal configurations. The ATS device has an open architecture truss designed to provide structural support with open space throughout the implant to allow fusion. ATS devices are intended for use with the Stryker T2 Ankle Arthrodesis Nail or the Stryker Valor Hindfoot Fusion Nail as part of a tibiotalocalcaneal (TTC) fusion system.

The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T 1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. If the device is being used without the CSTS Integrated Plate. supplemental fixation must be used.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of heights, footprints, and lordotic angles. The CSTS Integrated Plates come in multiple heights to accommodate the patient's anatomy. Screws are inserted through the anterior portion of the Integrated Plates into adjacent vertebral bodies for bony fixation. The Integrated Plates have a rotating locking tab to prevent back-out of the screws.

The Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels and is to be used with two titanium alloy screws or fixation anchors which accompany the device. DDD is defined as discogenic back pain with deqeneration of the disc confirmed by patient history and radiographic studies. CSTS-SA Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. When using the CTST-SA interbody with fixation anchors, the device must be used with supplemental fixation.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy. Screws or fixation anchors are inserted through the anterior portion of the implant into adjacent vertebral bodies for bony fixation.

The Cervical Spine Truss System (CSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) of the cervical spine at one level or two contiguous disc levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. CSTS Interbody Fusion Devices are used as an adjunct to fusion in the cervical spine and are placed via an anterior approach at the C2 to T1 disc levels using autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Patients should have received 6 weeks of non-operative treatment prior to treatment with the devices. The device must be used with supplement fixation.

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone through growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes to accommodate the patient's anatomy.

The HTS is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the HTS can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The 4WEB HTS implants consists of a series of titanium implants that are designed to provide stability and fixation of the lesser toes in the foot. The 4WEB HTS implants have proximal and distal fixation features to provide structural support and will be offered in multiple sizes to accommodate various patients' anatomy. The implants are manufactured from Ti6Al4V alloy. Each implant is available in a sterile/packaged form.

The Osteotomy Truss System (OTS) is intended to be used for internal bone fractures or osteotomies in the foot, such as: - · Opening wedge osteotomies of the foot including osteotomies for Hallux Valgus - · Opening wedge of Medial Cuneiform or Cotton osteotomies - · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) - · Metatarsal/Cuneiform osteotomies - · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform osteotomies (TMT or Lapidus) - · Hindfoot osteotomies The device is intended for use with supplemental fixation. The Osteotomy Truss System is not intended for use in the spine.

The Osteotomy Truss System (OTS) consists of three implant designs in a variety of footprints and opening wedge height options to accommodate the patient's anatomy. It is intended to be used with supplemental fixations. The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy.

The Cervical Spine Truss System Plating Solution (CSTS-PS) is intended for anterior interbody screw fixation of the cervical spine at levels C2-T1. The Cervical Spine Truss System Plating Solution (CSTS-PS) is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

The Cervical Spine Truss System Plating Solution (CSTS-PS) is comprised of cervical plates and screws. The cervical plates have a rotating locking tab for each double screw position to prevent back-out of the screw. The plates are available in 1-level, 3-level, 4-level, and 5-level configurations. Each plate is available in multiple lengths to accommodate varying patient anatomy. The screws are available in two diameters and various lengths. All CSTS-PS plates and screws are made from Ti6Al4V alloy.

The Lateral Spine Truss System (LSTS) Interbody Fusion Device is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. All LSTS Interbody Fusion Devices must be used with supplemental fixation and must be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. Interbodies with 18° lordosis or greater must be used with the 4WEB Lumbar Spine Truss System Plating Solution (LSTS-PS) with integrated fixation. If using the 1-hole 4WEB LSTS-PS with integrated fixation, additional supplemental fixation is required (e.g. posterior fixation). These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).

The device is an open architecture truss design mathematically formulated to provide structural support with open space throughout the implant for bone growth and fusion. The 4WEB additive manufacturing process provides a hierarchical surface roughness. The implant is made from Ti6Al4V alloy. The device is available in a variety of sizes and lordotic angles to accommodate the patient's anatomy.