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The FloSpine KeyLift™ Expandable Interlaminar Stabilization System is a posterior non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (TI-S1). It is intended for plate fixation/attachment to the spinous processes/lamina for the purpose of achieving supplemental fusion in the following conditions: Lumbar spinal stenosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), and/or tumor. The KeyLif("M Expandable Interlaminar Stabilization System is intended for use with allograft bone and is not intended for stand-alone use.

The KeyLift™ implant is an expandable, interlaminar stabilization device that is implanted posteriorly between the lamina and spinous processes of the thoracic and lumbar region. The implant features an expanding distal end which increases the height between the vertebral bodies. The superior and inferior wings are crimped to the spinous process, and a clamp is attached to the implant for final fixation. The components of the KeyLift™ system of implants and reusable instruments are manufactured from titanium alloy per ASTM F136 and stainless steel per ASTM F138 and A564. KeyLift™ implants are available in a range of sizes to accommodate surgeon and patient needs. Both the KeyLift implant and KeyLift Clamp are provided pre-assembled.

Ti-Largo™ Cervical Interbody Cages are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Ti-Largo™ Cervical Interbody Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C2 to T 1 disc levels using autograft bone. Ti-Largo™ Cervical Interbody Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage.

FloSpine Ti-Largo™ Cervical Interbody Cages are keystone shaped devices that have a central lumen and smaller graft windows throughout the structure of the implant. The implants are additively manufactured (ADM) using grade 23 titanium alloy powder per ASTM F3001. The implants are provided sterile (gamma radiation, 25 kGy minimum dose), are intended for single use only, and should not reused under any circumstances. Components from this system should not be used in conjunction with components from other company products. Ti-Largo™ Cervical Interbody Cages are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the cervical spine. The Ti-Largo™ Cervical Interbody System was developed for anterior cervical fusion with implants available in keystone shaped footprints ranging in size between 11 x 14mm and 16 x 18mm, thickness ranging from 5 to 14mm in 1 mm increments, 7degree lordosis for all sizes, and 0-degree lordosis for the smallest and largest sizes. The surface texture of the 3D structure of the implants resists expulsion forces.

The FloSpine PANAMA™ Anterior Cervical Plate System is intended for anterior cervical screw fixation of the cervical spine at levels C2-T1. The System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative discase (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis), or scoliosis), pseudoarthrosis, and/or failed previous fusions.

The PANAMA™ Anterior Cervical Plate System is an anterior cervical spine fixation system that provides cervical spine fixation for intervertebral disk replacement procedures. The PANAMA™ ACP System is designed to stabilize and facilitate fusion in intervertebral disk replacement surgeries. The PANAMA™ Anterior Cervical Plate (ACP) System consists of cervical plates that are 2.25 mm thick, 16 mm wide, and length options between 18 and 110 mm (end-to-end length) to accommodate 1 to 5 levels of fusion between C2 and T1. The PANAMA ACP System includes fixed and variable angle screws with 4.0mm and 4.5mm diameters and length options between 12mm and 20mm with self-tapping and self-drilling options. The screws and plates are made from Ti-6AI-4V ELI conforming to ASTM F-136. The plates and screws of the PANAMA™ ACP System include a primary and secondary mechanism to mitigate screw backout. The primary mechanism consists of a cover plate that is rotated in-situ that partially covers the screw. The secondary mechanism consists of a number of radial teeth on the screw head and mating grooves on the underside of the cover plate. In the event that the screws start to back out, the teeth and grooves will engage, thereby preventing further counter-clockwise rotation of the screw. The screws in the system have a threaded hole at the bottom of the drive to provide easy insertion and positioning during surgery. The PANAMA™ ACP System of implants and instruments is provided clean and non-sterile in one sterilization case.

Largo™ Interbody Cages - Cervical are indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Largo™ Interbody Cages - Cervical are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach at the C3 to C7 disc levels using autograft bone. Largo™ Interbody Cages - Cervical are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment with an intervertebral cage. Largo™ Interbody Cages - Lumbar are indicated for use with autograft bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). Largo™ Interbody Cages - Lumbar are intended to be used with supplemental spinal fixation systems, such as pedicle screws. Patients should be skeletally mature and have six (6) months of nonoperative therapy prior to treatment with an intervertebral cage.

The Largo™ PEEK Interbody System consists of a variety of hollow vertebral body spacers designed for use in the cervical and lumbar spine. The devices are intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the lumbar spine and cervical spine. The Largo™ PEEK Interbody Cervical Cage was developed for anterior cervical fusion and is available in footprints from 14 x 12mm up to 17 x 14mm and at 0 and 7 degree lordosis. The cages are trapezoidal in shape and include x-ray markers for positioning. The subject device is with angular teeth to allow the implant to grip the superior and inferior end plates to provide resistance to expulsion. The Largo™ PEEK Posterior Lumbar Interbody Cage (PLIF) was developed for posterior stabilization of the lumbar spine. These cages feature a convex bullet nose design and an axial void designed to contain autograft material. The subject device is made in various lengths and designed with angular teeth to allow the implant to grip the superior and inferior end plates to provide resistance to expulsion. The devices range from 7mm to 16mm in height, 23mm to 37mm in length, and from 9 to 11mm in width. The Largo™ PEEK Transforaminal Lumbar Interbody Fusion (TLIF) Cage was developed for posterior stabilization of the lumbar spine. It is a banana-shaped implant featuring a convex, bullet nose design and an axial void designed to hold autograft material. The subject device is made in various lengths and designed with angular teeth to allow the implant to grip the superior and inferior end plates to provide resistance to expulsion. The devices range from 7mm to 16mm in height and footprints of 11 x 28 up to 13 x 37 mm. The cages incorporate an A/P lordotic angle of 5 degrees. The Largo™ PEEK Anterior Lumbar Interbody Fusion (ALIF) Cage was developed for anterior stabilization of the lumbar spine. The footprint is oval in shape and features a center beam for additional strength. The leading edge is bulleted for ease of insertion and features angular teeth for endplate grip and resistance to expulsion. The devices range from 8mm to 22mm in height and footprints of 30 x 24 up to 47 x 30 mm. The cages incorporate an A/P lordotic angle of 6 or 12 degrees. The Largo™ PEEK Lateral Lumbar Interbody Fusion (LLIF) Cage was developed for a lateral approach to the lumbar spine. The cage is rectangular in shape and features a center beam for additional strength. The leading edge is bulleted for ease of insertion and features angular teeth for endplate grip and to resist expulsion. The devices range from 8mm to 16mm in height and footprints of 18 x 50 mm up to 22 x 60 mm. The cages incorporate an A/P lordotic angle of 0 or 6 degrees.

The FloSpine Canaveral Pedicle System is intended for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. When used for posterior non-cervical pediction in pediatric patients, the Canaveral Pedicle Screw System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Canaveral Pedicle Screw System for pediatric use is intended to be used with autograft. Pediatric pedicle screw fixation is limited to the posterior approach. The Canaveral Pedicle Screw System is indicated to provide the surgeon with a minimally invasive approach for posterior spine surgery.

The FloSpine Canaveral Pedicle Screw System comprises non-sterile, single use, titanium alloy components for creating a posterior spinal implant construct. The system attaches to the spine through a component system comprising of pedicle screw assemblies for open and minimally invasive procedures, rods, hooks and set screws. The system is designed to stabilize the spine during the fusion process. The screws are available as monoaxial, uniplanar and polyaxial screws in both cannulated and non-cannulated forms. The rods are available as straight and precurved rods and are available in 2 diameters and multiple lengths. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136. Some rods are made from cobalt chrome which complies with ASTM F1537.