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The Mega Plus Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

The Mega Plus Spine System is a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws (multi-axial, multi-axial long-arm, mono and long-arm), iliac screws, rods, locking bolts, cross-links and connectors. The Mega Plus Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Mega Plus Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the Mega Plus Spine System.

The INNESIS PEEK TL Cage is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The INNESIS PEEK TL Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Transforaminal Lumbar Interbody Fusion (T-LIF) technique. The INNESIS PEEK TL Cages are offered in a variety of heights, footprints and curved shapes. The device has ridges on both its inferior and superior surfaces, and two large graft windows which help facilitate bony integration. The device includes marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage. The INNESIS PEEK TL Cage components are manufactured from Polyetheretherketone (VESTAKEEP® 14 R, ASTM F2026). They contain marker made of medical grade titanium alloy (Ti6Al4V-ELI, ASTM F136). The INNESIS PEEK TL Cage and instrumentation set is sold non-sterile.

The INNESIS PEEK Cervical 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 (C2-T1). DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. INNESIS PEEK Cervical Cages are used to facilitate intervertebral body fusion in the cervical spine and are placed via an anterior approach and packed with autogenous bone. INNESIS PEEK Cervical Cages are to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The INNESIS PEEK Cervical Cage is an implant for the anterior stabilization of the cervical spinal column using an Anterior Cervical Desectorny and Fusion (ACDF) surgery. The INNESIS PEEK Cervical Cages are offered in a variety of heights, footprints and curved shapes. The INNESIS PEEK Cervical Cages have ridges or teeth that resist rotation and migration and have cavities to accept packing of bone graft. The INNESIS PEEK Cervical Cage includes spikes and marker (pin) for radiological evaluation of the position and orientation of the radiolucent PEEK Cage

The INNESIS PEEK Cages are indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. INNESIS PEEK Cages are to be used with autogenous bone graft and implanted via a posterior approach. The INNESIS PEEK Cages are to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.

The INNESIS PEEK Cage was developed as an implant for the posterior stabilization of the lumbar spinal column using a Posterior Lumbar Interbody Fusion (PLIF) technique and is used in pairs. The INNESIS PEEK implant incorporates ridges on both its superior and inférior surfaces to help eliminate migration. A graft space help facilitate bony integration once implanted. The implants are made of polyether-ether-ketone (PEEK) body with the x-ray markers made of Titanium alloy (Ti-6A1-4V).

The Dyna-EXTOR(L) II and Dyna-EXTOR(M) II external fixation systems are intended for the treatment of bone conditions that can be corrected or improved by external skeletal traction or fixation, including osteotomy, arthrodesis, fracture and reconstructive surgery. The Dyna-EXTOR(SM) II external fixation system is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities. Dyna-EXTOR(ST) II external fixation system is intended for use in external fixation of fractures and/ or reconstruction of small bones, including metacarpal and metatarsal.

The Dyna-EXTOR II is unilateral external fixation device. The system has 4 detailed systems according to the intended use. The Dyna-EXTOR 11 external fixation system is composed of pins or wires inserted into the bone, above and below the fracture or surgery site. These pins are then attached to a strong external frame. This allows the bone to be held relatively firmly, while some mobility and weight bearing can take place.

The DVX 5.5 Spine System is intended for posterior, noncervical, pedicle fixation in order to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attainment of solid fusion.

The DVX 5.5 Spine System (like the predicate The DVX Spine System) consists of four or more pedicle screws and two solid rods in a symmetric. bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The DVX5.5 Spine System ( See Figure 1) is made of components for fixation of the spine: multi-axial pedicle screws, locking cap, rod and cross-link . The materials, sterilization and packaging are the same as those in DVX Spine System, the predicate.

The DVX Spine System is intended for posterior, noncervical, pedicle fixation in order to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; spinal turnor; and failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the DVX Spine System is intended for skeletally mature patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra, who are receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 and below), with removal of the implants after the attaimment of solid fusion.

The DVX Spine System consists of four or more pedicle screws and two DVX solid rods in a symmetric, bilateral arrangement. The pedicle screws are placed axially in the pedicles with two screws in the cephalad position and two screws in the caudad position. The DVX rods are secured in the heads of the pedicle screws so that fixed stabilization is provided between the cephalad and caudad vertebrae. Cross-links can be used if additional stabilization is necessary. The DVX Spine System is fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136 -02a, Standard Specifications for Wrought Titanium-6Aluminum-4VanadiumELI (Extra Low Interstitial) Alloy or Surgical Implant Applications (UNS R56401

The MEGA Spine System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the MEGA Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

The MEGA Spine System is a top-loading multiple component, posterior spinal fixation systems which consist of pedicle screws, rods, locking bolt, and a cross(transverse) linking mechanism. The MEGA Spine System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The MEGA Spine System implant components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6A1-4V ELI) that conforms to the ASTM F136. Various sizes of these implants are available. Specialized instruments are also available for the application and removal of the MEGA Spine System.

The Pins are intended to be used in conjunction with a rigid external supporting frame for immobilization of open and/of unstable fractures and where the soft tissue injury may preclude the use of other fracture treatments such as IM rodding, casting and other means of internal fixation.

The Pin Screws have a tapered thread diameter and are available in a variety of diameter and lengths in both cortical and cancellous thread patterns. The Pin Screws will be available with and without the additional proprietary self-drilling on the threads. The Pin Screws are manufactured from surgical grade stainless steel, 316L per BK MEDITECH CO.,LTD. ASTM F138. The Pin Screws are inserted into the bone nearest the fracture site and connected externally to a rigid external supporting frame for immobilization of unstable fractures. The Pin Screws are provided non-sterile and must be cleaned and sterilized prior to use according to the procedures outlined in this document.