TITANIUM CD HORIZON SPINAL SYSTEM
Device Facts
| Record ID | K962708 |
|---|---|
| Device Name | TITANIUM CD HORIZON SPINAL SYSTEM |
| Applicant | Sofamor Danek USA,Inc. |
| Product Code | KWP · Orthopedic |
| Decision Date | Feb 6, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3050 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Titanium CD HORIZON™ Spinal System, when using screws for pedicle fixation, is intended only for patients: (a) having severe spondylolisthesis (Grades 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. Except for situations where screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a Titanium CD HORIZON™ construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the Titanium CD HORIZON™ Spinal System are the following: 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. Pseudoarthrosis 3. Stenosis 4. Spondylolisthesis 5. Spinal deformities: scoliosis, kyphosis, lordosis 6. Fracture 7. Unsuccessful previous attempts at spinal fusion 8. Tumor resection NOTA BENE: The Titanium CD HORIZON™ Spinal System is limited to non-cervical use. The titanium alloy CD HORIZON™ screws and the titanium alloy TSRH® Variable Angle Screws, when used as pedicle screws with the Titanium CD HORIZON™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (Grades 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. When used for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than L3 and not lower than the sacrum. Otherwise the titanium alloy CD HORIZON™ screws and the titanium alloy TSRH® Variable Angle Screws, when used with the Titanium CD HORIZON™ Spinal System, are intended for sacral/iliac attachment only. All of the titanium alloy CD HORIZON™ hooks are intended for thoracic and/or lumbar attachment only. The titanium alloy TSRH® Low Profile CROSSLINK® Offset Plate, the titanium alloy TSRH® Low Profile CROSSLINK® plates, and the titanium alloy CD HORIZON™ Low Profile MULTI-SPAN® CROSSLINK® plates are intended for posterior thoracic, lumbar, and/or sacral use only.
Device Story
Spinal fixation system consisting of titanium alloy rods, hooks, screws, and crosslink plates; components rigidly locked into patient-specific constructs. Used by surgeons in posterior spinal procedures to stabilize the spine during fusion. Provides mechanical support for degenerative conditions, deformities, and fractures. System components are modular, allowing for tailor-made constructs. Titanium alloy construction ensures biocompatibility. Device is non-cervical; pedicle screw use is highly restricted to specific spondylolisthesis cases requiring subsequent removal. Instruments provided to facilitate surgical implantation.
Clinical Evidence
Bench testing only.
Technological Characteristics
Materials: Titanium alloy (ASTM F136) and commercially pure titanium (ASTM F67). Components: 6.35mm rods, hooks, screws (5.5mm-7.5mm), and crosslink plates. Modular design for rigid locking configurations. Non-cervical use. Sterilization: Sold sterile or non-sterile.
Indications for Use
Indicated for patients requiring non-cervical spinal fixation for degenerative disc disease, pseudoarthrosis, stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, lordosis), fractures, failed fusions, or tumor resection. Pedicle screw use restricted to severe L5-S1 spondylolisthesis (Grades 3-4) with autogenous bone graft, requiring removal after fusion; pedicle screws limited to L3-sacrum. Hooks for thoracic/lumbar use; plates for posterior thoracic/lumbar/sacral use.
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.
Reference Devices
- TSRH® Spinal System
Related Devices
- K970635 — TITANIUM SPINAL ROD SYSTEM · Smith & Nephew, Inc., Orthopaedic Div. · Aug 14, 1997
- K100956 — SPONDY SPINAL FIXATION SYSTEM · Allure Spine LLC · Jul 9, 2010
- K111448 — ICON (TM) MODULAR PEDICLE SCREW SYSTEM · Orthofix, Inc. · Feb 16, 2012
- K030862 — BLACKSTONE SPINAL FIXATION SYSTEM RIGID CROSS CONNECTOR · Blackstone Medical, Inc. · Apr 17, 2003
- K043578 — THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM · Solco Biomedical Co., Ltd. · Mar 7, 2005
