← Product Code [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP) · K964275 # ALPHA POSTERIOR SPINAL SYSTEM (K964275) _Sofamor Danek USA,Inc. · KWP · Jan 14, 1997 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K964275 ## Device Facts - **Applicant:** Sofamor Danek USA,Inc. - **Product Code:** [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP.md) - **Decision Date:** Jan 14, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3050 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **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. ## Regulatory 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 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} JAN 09 '97 01:50PM SOFAMOR DANEK P.16/17 # ALPHA™ Posterior Spinal System 510(k) Summary K964275 K964275 January, 1997 *JAN.14, 1997* I. Company: Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 901-396-3133 II. Proprietary Trade Name: ALPHA™ Posterior Spinal System Classification Name: Pedicle Screw Fixation - Spondylolisthesis spinal fixation device system. III. The ALPHA™ Posterior Spinal System is a spinal rod based system. The ALPHA™ implant components, as well as implant components from the other systems, can be rigidly locked into a variety of configurations, with each construct being tailor-made for the individual case. Implant components comprising the ALPHA system and those components from other Sofamor Danek spinal systems which can be used with the ALPHA™ Posterior Spinal System are listed in the following table. Please note that while the set screws can be used on both size rods, all of the other components are rod-size specific. | Component | 5.5mm Diameter Rod | 6.35mm Diameter Rod | | --- | --- | --- | | Rods: TSRH® Rods | | ☑ | | GDLH™ Rods | ☑ | | | ALPHA™ Rod | | ☑ | | Screws: ALPHA™ Screws 5.5mm, 6.5mm, 7.5mm diameter | ☑ | ☑ | | Connectors and Cross Connectors: CD HORIZON™ M-10 Break-Off Set Screw | ☑ | ☑ | | ALPHA™ M-10 Break-Off Set Screw | ☑ | ☑ | | CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® Plates | ☑ | ☑ | | ALPHA™ Low Profile MULTI-SPAN™ CROSSLINK® Plates | ☑ | ☑ | | TSRH® Low Profile CROSSLINK® Offset Plates | ☑ | ☑ | | TSRH® Low Profile CROSSLINK® Plates | ☑ | ☑ | | TSRH® CROSSLINK® Plate Set Screws | ☑ | ☑ | IV. The ALPHA™ Posterior Spinal 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. {1} JAN 09 '97 01:51PM SOFAMOR DANEK P.17/17 NOTA BENE: 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™ Posterior Spinal System 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. 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. V. Mechanical test data were supplied in support of the ALPHA™ Posterior Spinal System 510(k) notification. The ALPHA™ Posterior Spinal System was declared to be substantially equivalent to several commercially available devices. ©1997 Sofamor Danek --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K964275](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K964275) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com