← Product Code [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ) · K964623 # TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM (K964623) _Sofamor Danek USA,Inc. · KWQ · Feb 6, 1997 · Orthopedic · SN_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K964623 ## Device Facts - **Applicant:** Sofamor Danek USA,Inc. - **Product Code:** [KWQ](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ.md) - **Decision Date:** Feb 6, 1997 - **Decision:** SN - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3060 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Titanium CD HORIZON™ Anterior Spinal System is intended to assist in temporarily stabilizing the thoracic and/or lumbar spine until fracture repair or a solid spinal fusion develops. ## Device Story System comprises titanium alloy and commercially pure titanium rods, screws, and staples; designed for temporary stabilization of thoracic/lumbar spine. Implants attached to anterolateral spine via screws/staples to facilitate fracture repair or spinal fusion. Used by surgeons in clinical/OR settings. Titanium components must not be mixed with stainless steel in spinal constructs. System includes instrumentation for implantation; components provided sterile or non-sterile. ## Clinical Evidence Bench testing only; no clinical data provided. ## Technological Characteristics Materials: Titanium alloy (ASTM F136) and commercially pure titanium (ASTM F67). Components: 6.35mm diameter rods, 5.5mm-7.5mm diameter screws, break-off set screws, staples. Fixation: Anterolateral thoracic/lumbar spine. Sterilization: Sterile or non-sterile. ## 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} FEB 04 '97 02:09PM SOFAMOR DANEK P.12/13 FEB - 6 1997 # Titanium CD HORIZON™ Anterior Spinal System 510(k) Summary K964623 February, 1997 I. Company: Sofamor Danek USA 1800 Pyramid Place Memphis, TN 38132 901-396-3133 II. Proprietary Trade Name: Titanium CD HORIZON™ Anterior Spinal System Classification Name: Spinal intervertebral body fixation orthosis. III. The Titanium CD HORIZON™ Anterior Spinal System consists of the following implants components: - CD HORIZON™ rod (commercially pure titanium), 6.35mm diameter - CD HORIZON™ knurled rod (titanium alloy), 6.35mm diameter - TSRH® rod (titanium alloy), 6.35mm diameter - CD HORIZON™ screws (titanium alloy), 5.5mm, 6.5mm, and 7.5mm diameters - CD HORIZON™ Break-Off Set Screw (titanium alloy) - CD HORIZON™ Staples (titanium alloy) The Titanium TSRH® rod can be used with the Titanium CD HORIZON™ Anterior Spinal System. Instrumentation is also available to facilitate implantation of the device components. The Titanium CD HORIZON™ Anterior Spinal System implant components are fabricated from ASTM F136 (or its ISO equivalent) titanium alloy. In addition, the Titanium CD HORIZON™ Anterior Spinal System has a rod fabricated from commercially pure titanium conforming to ASTM F67 or its ISO equivalent. The implant components may be sold sterile or non-sterile. Titanium implants are not to be used with stainless steel implant components in a spinal construct. IV. The Titanium CD HORIZON™ Anterior Spinal System is intended to assist in temporarily stabilizing the thoracic and/or lumbar spine until fracture repair or a solid spinal fusion develops. The specific indications for the CD HORIZON™ Anterior Spinal System are the following: {1} FEB 04 '97 02:10PM SOFAMOR DANEK 2.13/13 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 Titanium 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 Titanium CD HORIZON™ Anterior Spinal System 510(k) notification. The Titanium CD HORIZON™ Anterior Spinal System was declared to be substantially equivalent to other commercially available devices. © 1997 Sofamor Danek --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K964623](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWQ/K964623) **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. 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