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When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using bone graft, the TSRH® Spinal System is indicated for one or more of the following: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the TSRH® Spinal System is indicated for skeletally mature patients using bone graft: (1) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint: (2) who are receiving fusions using autogenous bone graft only: (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the TSRH® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6)pseudarthrosis, (7) turnor resection, and/or (8) unsuccessful previous attempts at spinal fusion.

When used as a unilateral supplemental fixation device in the antero-lateral thoracic/lumbar region, the TSRH® L-Plate and VANTAGE™ screws are intended for the following indications: spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.

For anterior use only the TSRH® Spinal System has the additional indication of: spondylolysis.

The purpose of this Special 510(k) is to add additional bone screws (TSRH® 3Dx™ Threaded Post Screws, TSRH® 3Dx™ Threaded Multi-Planar Adjusting (MPA) Post Screws, and TSRH® 3Dx™ Short MPA Post Screws) to the TSRH® Spinal System.

The TSRH® Spinal System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine.

The TSRH® Spinal System consists of a variety of shapes and sizes of rods, hooks, screws, cross connectors, staples, plates and connecting components as well as implant components from other Medtronic spinal systems, which can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case.

Certain implant components from other Medtronic spinal systems can be used with the These components include GDLH® rods, GDLH® rod/bolt TSRH® Spinal System. connectors, GDLH® Variable Angle T-Bolts, GDLH® set screws and locking screws, DYNALOK® PLUS™ bolts, CD HORIZON® Low Profile MULTI-SPAN® CROSSLINK® Plates, VANTAGE™ Anterior Fixation System screws, and CD HORIZON® rods, screws, set screws and locking screws.

The hooks are intended for posterior use only and the staples are for anterior use only. The TSRH-3D® and TSRH-3Dx™ connectors and TSRH-3D® and TSRH-3Dx™ screws are intended for posterior use only. ALL CROSSLINK® Plates are for posterior use and the CROSSLINK® Axial and Offset Plates may be used anteriorly as well.

The TSRH® Spinal System components are fabricated from medical grade stainless steel. Alternatively, they may be fabricated from medical grade titanium alloy or medical grade titanium. The subject components will be manufactured from medical grade titanium alloy described by such standards as ASTM F136 or ISO 5832-3. The TSRH® Spinal System may be sold sterile or non-sterile.

The provided text is a 510(k) summary for a medical device (TSRH® Spinal System) and explicitly states that the purpose of the submission is to add additional bone screws to an existing system. It describes the device, its indications for use, and confirms its substantial equivalence to previously cleared devices.

Crucially, this document does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case studies related to the performance of the device in meeting specific clinical or diagnostic criteria.

The "Substantial Equivalence" section states: "Documentation, including a risk analysis, was provided which demonstrated the subject screws to be substantially equivalent to TSRH® Spinal System components manufactured by Medtronic Sofamor Danek and cleared by the FDA in K072429 (S.E. 09/28/2007) and K090740 (S.E. 08/14/2009)."

This indicates that the manufacturer demonstrated substantial equivalence, likely through material testing, mechanical testing, and comparison of design features and indications for use against predicate devices, rather than through a clinical performance study in the context of diagnostic accuracy or a similar measure that would have acceptance criteria and a detailed study design as requested.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory approval through substantial equivalence, not on a detailed clinical performance study with acceptance criteria for a new diagnostic or assistive technology.

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