← Product Code [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ) · K963655 # CD HORIZON ANTERIOR SPINAL SYSTEM (K963655) _Sofamor Danek USA,Inc. · KWQ · Nov 27, 1996 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K963655 ## Device Facts - **Applicant:** Sofamor Danek USA,Inc. - **Product Code:** [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ.md) - **Decision Date:** Nov 27, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3060 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The CD HORIZON™ Anterior Spinal System is designed to aid in the surgical correction and stabilization of the spine. The system is intended to assist stabilization until a solid spinal fusion develops. The specific indications for the CD HORIZON™ Anterior 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 All components of the CD HORIZON™ Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only. ## Device Story System consists of rods, screws, set screws, and staples for anterolateral spinal fixation. Provides stabilization to facilitate solid spinal fusion. Used by surgeons in clinical settings. Components compatible with 5.5mm and 6.35mm rods (GDLH, TSRH, LIBERTY). Implants fixed to thoracic/lumbar spine via screws/staples. Benefits include structural support during bone healing. ## Clinical Evidence Bench testing only; mechanical test data supplied to support substantial equivalence. ## Technological Characteristics Components fabricated from ASTM F138 stainless steel (or ISO equivalent). System includes rods (5.5mm/6.35mm), screws, set screws, and staples. Sold sterile or non-sterile. Stainless steel components must not be mixed with titanium alloy in a single construct. ## Regulatory Identification A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions. ## 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} NOV 19 '96 02:53PM SOFAMOR DANEK -14/14 # CD HORIZON™ Anterior Spinal System 510(k) Summary K963655 November, 1996 NOV 27 1996 I. Company: Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 901-396-3133 II. Proprietary Trade Name: CD HORIZON™ Anterior Spinal System Classification Name: Spinal intervertebral body fixation orthosis. III. The CD HORIZON™ Anterior Spinal System consists of rods, screws, a set screw, and staples. In general, the system features implant components which can be used with either 5.5mm and 6.35mm Sofamor Danek rods. The 5.5mm GDLH™, 6.35mm TSRH®, and 6.35mm LIBERTY™ rods can be used with the CD HORIZON™ Anterior Spinal System. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CD HORIZON™ Anterior Spinal System is to provide stabilization during the development of a solid spinal fusion. The CD HORIZON™ Anterior Spinal System implant components are fabricated from ASTM F138 (or its ISO equivalent) stainless steel and may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implant components in a spinal construct. IV. The CD HORIZON™ Anterior Spinal System is designed to aid in the surgical correction and stabilization of the spine. The system is intended to assist stabilization until a solid spinal fusion develops. The specific indications for the CD HORIZON™ Anterior 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 All components of the CD HORIZON™ Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only. V. Mechanical test data were supplied in support of the CD HORIZON™ Anterior Spinal System 510(k) notification. The CD HORIZON™ Anterior Spinal System was declared to be substantially equivalent to several commercially available devices. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K963655](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K963655) **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