Who is the manufacturer of TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM?

Sofamor Danek USA,Inc. submitted the Traditional clearance for TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM (K964623).

What is the FDA product code for TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM?

KWQ. It is classified under 21 CFR 888.3060 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM?

510(k) clearance (submission type: Traditional).

TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM

K964623 · Sofamor Danek USA,Inc. · KWQ · Feb 6, 1997 · Orthopedic

Device Facts

Record ID	K964623
Device Name	TITANIUM CD HORIZON ANTERIOR SPINAL SYSTEM
Applicant	Sofamor Danek USA,Inc.
Product Code	KWQ · Orthopedic
Decision Date	Feb 6, 1997
Decision	SN
Submission Type	Traditional
Regulation	21 CFR 888.3060
Device Class	Class 2
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.

Indications for Use

Indicated for patients with degenerative disc disease (discogenic back pain confirmed by history/radiography), pseudoarthrosis, stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, lordosis), fracture, failed previous spinal fusion, or tumor resection. Intended for anterolateral thoracic and/or lumbar spine fixation.

Regulatory Classification

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.

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Submission Summary (Full Text)

{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