ALPHA POSTERIOR SPINAL SYSTEM
Device Facts
| Record ID | K964275 |
|---|---|
| Device Name | ALPHA POSTERIOR SPINAL SYSTEM |
| Applicant | Sofamor Danek USA,Inc. |
| Product Code | KWP · Orthopedic |
| Decision Date | Jan 14, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3050 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The ALPHA™ Posterior Spinal System is intended to provide temporary stabilization and to help augment the development of a solid spinal fusion. The system is intended only 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 (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass. The ALPHA™ Posterior Spinal System is limited to non-cervical use. All implant components of the ALPHA™ Posterior Spinal System are intended for posterior spinal fixation. The ALPHA™ screws are indicated only for insertion no higher than L3 and not lower than the sacrum. CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates, ALPHA™ Low Profile MULTI-SPAN™ CROSSLINK® plates, TSRH® Low Profile CROSSLINK® plates, and TSRH® Low Profile CROSSLINK® Offset plates are intended for posterior thoracic, lumbar, and/or sacral use only.
Device Story
ALPHA™ Posterior Spinal System is a rod-based spinal fixation system; provides temporary stabilization to facilitate solid spinal fusion. Components include rods, pedicle screws, connectors, and cross-connectors; components are rigidly locked into configurations tailor-made for individual cases. Used in posterior spinal surgery; implanted by surgeons. System components are rod-size specific (5.5mm or 6.35mm). Device intended for removal after fusion mass development. Benefits include stabilization of severe spondylolisthesis (Grades 3 and 4) at L5-S1.
Clinical Evidence
Bench testing only.
Technological Characteristics
Spinal rod-based fixation system. Components include rods, screws, connectors, and cross-connectors. Rod diameters: 5.5mm and 6.35mm. Screw diameters: 5.5mm, 6.5mm, 7.5mm. Rigid locking mechanism via set screws.
Indications for Use
Indicated for patients with severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebral joint requiring temporary stabilization to augment solid spinal fusion using autogenous bone graft. Device fixed to lumbar and sacral spine (L3 and below). 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.
Reference Devices
- TSRH® Rods
- GDLH™ Rods
- CD HORIZON™ M-10 Break-Off Set Screw
- CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates
- TSRH® Low Profile CROSSLINK® Offset Plates
- TSRH® Low Profile CROSSLINK® Plates
- TSRH® CROSSLINK® Plate Set Screws
Related Devices
- K230482 — Swedge Pedicle Screw Fixation System · Spinal Resources, Inc. · Mar 23, 2023
- K955807 — COTREL-DUBOUSSET (CD) SPINAL · Sofamor Danek USA,Inc. · Oct 1, 1996
- K150294 — DPZ Pedicular Fixation System · Osteomed Implantes, Ltda · Jun 5, 2015
- K023438 — MODIFICATION TO MONARCH SPINE SYSTEM · Depuyacromed · Nov 13, 2002
- K964533 — EBI SPINELINK SYSTEM · Electro-Biology, Inc. · Apr 9, 1997
