COTREL-DUBOUSSET (CD) SPINAL
Device Facts
| Record ID | K955807 |
|---|---|
| Device Name | COTREL-DUBOUSSET (CD) SPINAL |
| Applicant | Sofamor Danek USA,Inc. |
| Product Code | KWP · Orthopedic |
| Decision Date | Oct 1, 1996 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3050 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The CD™ Spinal System consists of rods, hooks, screws, connectors, cross connectors, and other components used to build a spinal construct. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CD™ Spinal System is to provide stabilization during the development of a solid spinal fusion. The CD™ Spinal System implant components are fabricated from ASTM F138 or its ISO equivalent stainless steel and may be sold sterile or non-sterile. Implant components made from different metal alloys must not be used together in a construct. The CD™ Spinal System is limited to non-cervical use in the posterior spine. The CD spinal screws, when used as pedicle screws with the CD™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (grade 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass. Otherwise, the CD screws, when used in posterior fixation, are intended for sacral/iliac attachment only. Except for situations where stainless steel screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a CD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the CD Spinal System (either stainless steel or titanium alloy versions) are the following: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by radiographic studies). 2. Pseudoarthrosis 3. Stenosis 4. Spondylolisthesis 5. Spinal deformities: scoliosis, kyphosis, and lordosis 6. Fracture 7. Unsuccessful previous attempts at spinal fusion 8. Tumor resection All of the CD hooks are intended for posterior thoracic and/or lumbar use only. CD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.
Device Story
Spinal fixation system; provides stabilization during spinal fusion. Components: rods, hooks, screws, connectors, cross-connectors. Implantation via posterior surgical approach; performed by orthopedic or neurosurgeons. Provides mechanical support to spine; facilitates fusion development. Pedicle screws indicated for severe L5-S1 spondylolisthesis; other components for degenerative disc disease, deformities, fractures, tumors. Device removed after solid fusion mass development for specific pedicle screw applications. Benefits: spinal stabilization, correction of deformities, support for fusion.
Clinical Evidence
No clinical data provided; bench testing only.
Technological Characteristics
Materials: ASTM F138 stainless steel or ISO equivalent. Components: rods, hooks, screws, connectors, cross-connectors. Non-cervical posterior spinal application. Mechanical fixation system. Sold sterile or non-sterile.
Indications for Use
Indicated for patients requiring posterior spinal stabilization for degenerative disc disease, pseudoarthrosis, stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, lordosis), fractures, failed fusion, or tumor resection. Pedicle screw use restricted to severe L5-S1 spondylolisthesis (Grade 3-4) with autogenous bone graft and subsequent device removal. Non-cervical use only.
Regulatory Classification
Identification
A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
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