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The PROW FUSION-L is intended for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 through S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION-L device is intended to be used with autogenous bone graft and a supplemental spinal fixation system that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems).

PROW FUSION-L is lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. PROW FUSION-L is provided in different sizes to fit the anatomical needs of a wide variety of patients. PROW FUSION-L is manufactured from titanium alloy per ASTM F136 and Polyetheretherketone per ASTM F 2026. The device contains an expandable mechanism that allows it to achieve its final footprint in situ. PROW FUSION-L is to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae. The devices require the use of commercially available supplemental spinal fixation systems.

PROW FUSION-V is an interbody fusion device intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). 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 at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). PROW FUSION-V is to be filled with autogenous bone graft material. The device is intended to be used with supplemental fixation.

PROW FUSION-V is lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. PROW FUSION-V is provided in different shapes to fit the anatomical needs of a wide variety of patients and can expand to the desired height or the desired lordosis. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adiacent vertebrae to resist expulsion. The devices require the use of commercially available supplemental spinal fixation systems. PROW FUSION-V is manufactured from titanium alloy per ASTM F136. PROW FUSION-V is to be filled with autogenous bone graft material.

The PROW FUSION Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through SI in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems). The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the PROW FUSION device. The PROW FUSION intervertebral body fusion device must be inserted using a transforaminal approach.

The PROW FUSION Intervertbral Body Fusion Device system is comprised of two components. One component is the single-use PROW FUSION implant (intervertebral body fusion device) of various heights and the second component is a set of reusable instruments (the PROW FUSION Delivery System) used for its implantation. The implant is made from PEEK and titanium alloy. The implant features 4 PEEK mid segments and titanium end segments has coarse surface on the superior and inferior surfaces and are attached with titanium pins. The PROW FUSION intervertebral body fusion implant is inserted using a transforaminal approach. The proximal and the distal segments are bound together by PEEK strip is used to pull the distal segment proximally to form a ring-shaped, closed-configuration implant in the disc space.

The eSPIN System is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).

The eSPIN System consists of access and positioning instruments to access the disc space and to position the hand-piece for discectomy, a handpiece, disposable cutting tips, a suction tube & alignments guide and electrical motor unit.

The Prow-Fusion Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through S1 in skeletally mature patients with degenerative disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems). The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Prow Fusion device. The Prow Fusion intervertebral body fusion device must be inserted using a transforaminal approach.

The Prow Fusion Intervertbral Body Fusion Device system is comprised of two components. One component is the single-use Prow Fusion implant (intervertebral body fusion device) of various heights and the second component is a set of reusable instruments (the Prow Fusion Delivery System) used for its implantation. The implant is made from PEEK-OPTIMA® LT1 & LT2 and titanium alloy. The implant features 4 PEEK-OPTIMA® LT1 mid segments and titanium end segments. The segments has coarse surface on the superior and inferior surfaces and are attached with titanium pins. The Prow Fusion intervertebral body fusion implant is inserted using a transforaminal approach. The proximal and the distal segments are bound together by PEEK-OPTIMA® LT2 strip. The PEEK-OPTIMA® LT2 strip is used to pull the distal seament proximally to form a ring-shaped, closed-configuration implant in the disc space.

The eSPIN is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems.

The eSPIN powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and direct connection to a motor via motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator unit for discectomy. The eSPIN needs to be connected to an electrical motor or drill. The required motor/drill specifications are provided in the eSPIN User Manual. The primary changes from the cleared eSPIN are: Addition of Suction tube and irrigation system. Minor modifications to the device design.

The eSpin is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).

The eSpin powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and a motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator for discectomy. The eSpin needs to be connected to an Electrical Motor. The required motor specifications are provided in the eSpin User Manual.

The Prow Fusion is intended to be used for spinal fusion. The Prow-Fusion Intervertebral body fusion device is indicated for spinal fusion procedures at one or two contiguous levels from L2 through S1 in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The patient may have had a previous non-fusion spinal surgery at the involved spinal level(s). The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems). The device is intended to be used with autogenous bone graft. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the Prow Fusion device. The Prow Fusion intervertebral body fusion device must be inserted using a transforaminal approach.

The Prow Fusion Intervertbral Body Fusion Device system is comprised of two components. One component is the single-use Prow Fusion implant (intervertebral body fusion device) of various heights and the second component is a set of reusable instruments (the Prow Fusion Delivery System) used for its implantation. The implant is made from PEEK enriched with carbon fibers (CFPEEK) and titanium alloy. The implant features multiple CFPEEK mid segments and titanium end segments. The segments are serrated on the superior and inferior surfaces and are attached with titanium pins. The Prow Fusion intervertebral body fusion implant is inserted using a transforaminal approach. The proximal and the distal segments are bound together by ultra high molecular weight poly ethylene (UHMWPE) suture. The suture is used to pull the distal segment proximally to form a ring-shaped, closed-configuration implant in the disc space.