Search Results

The Premier is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine (T1-S1): 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); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).

The purpose of this 510(k) is to make modifications to the previously cleared Premier Spinal System (K160320). The changes include modifications to the implants, surgical instruments, indications and labeling. The Premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, iliac screw, domino connector, lateral connector and hooks. It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Allov for Surgical Implant Applications, which are widely used for surgical implants with wellknown biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 106 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The Premier is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization of the spine as an adjunct to fusion with bone graft.

The premier consists of fixed-angle screws, fix-angle reduction screws, multi-axial screws, multi-axial reduction screws, rods, crosslink plates, set screws, planar screw, domino connector, lateral connector and hooks. It is made of Titanium Alloy (Ti6Al4V), which meets ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well-known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10^-6 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

The Milestone™ Spinal System is indicated for interbody fusion with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two levels from L2 to S1. These DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved level. These patients should be skeletally mature and have had six months of non-operative treatment. These implants may be implanted via an open or a minimally invasive posterior approach. Alternatively, these implants may also be implanted via transforaminal approach. These implants are to be used with autogenous bone graft. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These devices are intended to be used with supplemental fixation instrumentation, which has been cleared by the FDA for use in the lumbar spine.

The Milestone Spinal System consists of INVIBIO PEEK-OPTIMA LT1 lumbar cages of various lengths and heights, which can be inserted between two lumbosacral vertebral bodies to give support and correction during lumbar interbody fusion surgeries. They are designed with angular teeth to allow the implant to grip the superior and inferior end plates. The hollow geometry of the implants allows them to be packed with autogenous bone graft in lumbar interbody fusion procedures. The cages contain radiographic tantalum markers used for both intra and post-operative positioning and visualization. The cages are provided sterile. The Milestone Spinal System also includes various device specific instruments which are provided non-sterile.

The General Spinal System is intended for posterior, non-cervical, pedicle fixation for the following indications: severe spondylolisthesis (grade 3 or 4) of the L5-S1 vertebrae; trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. The device is to be used in skeletally mature patients, and for stabilization and immobilization of the spine as an adjunct to fusion with bone graft. The levels of fixation are T8 - S1.

The spinal system consists of screws, rods, crosslink plates, set screws and hooks. It is made of Titanium Alloy (Ti6Al4VELI), which meets ASTM F136-02a, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications, which are widely used for surgical implants with well known biocompatibility. The proposed devices are provided non-sterile. It is required to be sterilized via autoclave method to reach a SAL of 10 by the hospital prior to surgery. The recommended sterilization method was validated per ISO 17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development. validation, and routine control of a sterilization process for medical devices

Locking Bone Plates and Screws are intended for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

The proposed products, Locking Bone Plates and Screws, contain (1) locking plats with various specifications, (2) locking screws with various specifications and (3) Various specific instruments. The bone plates are used for internal fixation of bones, screws are used for fix the plates on the bones, and instruments are used for completing the surgery. Locking Screws are available in two kinds, which are self-dapping and self-drilling. Both of them share the same dimensions and materials. These devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10th by hospital prior to use.

The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy.

The Anterior Cervical Plate System is indicated for stabilization of the cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: instability caused by trauma; instability associated with correction of cervical lordosis and kyphosis deformity; instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery; instability associated with major reconstructive surgery for primary tumors or metatstatic malignant tumors of the cervical spine; instability associated with single or multiple level corpectomy in advanced degenerative disc disease, spinal canal stenosis and cervical myelopathy. The plates with lowest profile are available several configurations, including different levels and lengths. It accommodates both semi-constrained constructs in which the variable screws are used for fixation, and constrained applications in which the fixed screws are rigidly locked to the plate attach to the anterior cervical spine with a minimum of four screws per plate. The screws are also available in several configurations, including types (screw and self-tapping screw), locking methods (fixed locking and variable locking), diameters and various lengths. All implants of Anterior Cervical Plate System are manufactured from Titanium alloy that meets the requirements of ASTM F136-11, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The materials are wildly used in the industry with well-known biocompatibility. No new materials are used in the development of this implant. This system is provided non-sterile.

· Simple, compound first- and second-degree tibial shaft fractures · Pseudarthrosis and delayed union

The Intramedullary Nail System is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. It consists of Intramedullary nail, Locking screw and End cap. The Intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail. The Locking screw passes through the holes at the proximal distal sections of intramedullary nail for preventing rotation and axial compression. The End cap which screws into the threaded end of the intramedullary nail provides intraoperative lengths adjustment and prevents tissues growth into nail threads. All implants of Intramedullary Nail System are manufactured from Ti-6AI-4V alloy that meets the requirements of ASTM F-136. The materials are wildly used in the industry with well known biocompatibility. No new materials are used in the development of this implant.