LIBERTY ANTERIOR SPINAL SYSTEM

K965193 · Sofamor Danek USA,Inc. · KWQ · Mar 17, 1997 · Orthopedic

Device Facts

• Record ID: K965193
• Device Name: LIBERTY ANTERIOR SPINAL SYSTEM
• Applicant: Sofamor Danek USA,Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 17, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LIBERTY™ 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 LIBERTY™ 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, lordosis, kyphosis 6. Fracture 7. Unsuccessful previous attempts at spinal fusion 8. Tumor resection All components of the LIBERTY™ Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only. WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Story

System consists of rods, screws, connectors, and staples for anterolateral spinal fixation. Used by surgeons to provide temporary stabilization during fracture repair or spinal fusion. Components implanted in thoracic and/or lumbar spine. Construct may involve single or dual rods. Titanium and stainless steel components must not be mixed in a single construct. Device provides mechanical support to the spine; facilitates fusion or healing. Sold sterile or non-sterile.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: ASTM F138 stainless steel, ASTM F136 titanium alloy, ASTM F67 commercially pure titanium. Components: rods (6.35mm), screws (5.5mm-7.5mm), staples, connectors. Anterolateral fixation. Non-active, mechanical device.

Indications for Use

Indicated for patients requiring temporary stabilization of the thoracic and/or lumbar spine for degenerative disc disease, pseudoarthrosis, stenosis, spondylolisthesis, spinal deformities (scoliosis, lordosis, kyphosis), fracture, failed fusion, or tumor resection. Contraindicated for posterior element (pedicle) fixation in cervical, thoracic, or lumbar spine.

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.

Reference Devices

• TSRH® Spinal System
• CD HORIZON® Spinal System

Submission Summary (Full Text)

{0}

MAR 10 '97 02:44PM SOFAMOR DANEK
P.18/20

LIBERTY™ Anterior Spinal System
510(k) Summary
K965193
March, 1997
MAR 17 1997

I. Company: Sofamor Danek USA
1800 Pyramid Place
Memphis, TN 38132
901-396-3133

II. Proprietary Trade Name: LIBERTY™ Anterior Spinal System
Classification Name: Spinal intervertebral body fixation orthosis.

III. The LIBERTY™ Anterior Spinal System consists of the following implants components:

| Component | Stainless Steel | Titanium Alloy | Commercially Pure Titanium |
| --- | --- | --- | --- |
| Rods: | | | |
| LIBERTY™ Rods, 6.35mm diameter | ☑ | | |
| TSRH® Rods, 6.35mm diameter | ☑ | ☑ | |
| CD HORIZON® Knurled Rod, 6.35mm diameter | | ☑ | |
| CD HORIZON® Rod, 6.35mm diameter | | | ☑ |
| Screws: | | | |
| LIBERTY™ Closed Screws-5.5mm, 6.5mm, 7.5mm diameter | ☑ | | |
| LIBERTY™ Closed Screws-6.5mm, 7.5mm diameter | | ☑ | |
| LIBERTY™ Closed Screw w/10° Oblique Canal-6.5mm, 7.5mm diameter | ☑ | | |
| LIBERTY™ Closed Screw w/15° Oblique Canal-6.5mm, 7.5mm diameter | ☑ | | |
| LIBERTY™ Open Screw-5.5mm, 6.5mm, 7.5mm diameter | ☑ | | |
| Connectors and Cross Connectors: | | | |
| LIBERTY™ 12-32 Break-Off Set Screw | ☑ | ☑ | |
| LIBERTY™ Open Implant Closure Saddle | ☑ | | |
| TSRH® Single Hole Staples | ☑ | | ☑ |
| TSRH® Two Hole Offset Staples, Left and Right | ☑ | ☑ | |
| TSRH® Washer | ☑ | ☑ | |
| TSRH® Low Profile CROSSLINK® Offset Plate | ☑ | ☑ | |
| TSRH® Low Profile CROSSLINK® Plate, 0.625 in length | ☑ | ☑ | |
| TSRH® Low Profile CROSSLINK® Plate Set Screws | ☑ | ☑ | |

{1}

MAR 10 '97 02:45PM SOFAMOR DANEK P.19/20

The LIBERTY™ Anterior Spinal System implant components are fabricated from ASTM F138 (or its ISO equivalent) stainless steel or from ASTM F136 (or its ISO equivalent) titanium alloy. In addition, one of the CD HORIZON spinal rods which may be used with the LIBERTY™ Anterior Spinal System and the TSRH® Single Hole Anterior Staples are fabricated from commercially pure titanium conforming to ASTM F67 or its ISO equivalent. Titanium implants are not to be used with stainless steel implant components in a spinal construct. A LIBERTY anterior construct may involve either a single rod or two rods. The implant components may be sold sterile or non-sterile. Instrumentation is also available to facilitate implantation of the device components.

IV. The LIBERTY™ 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 LIBERTY™ 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, lordosis, kyphosis
6. Fracture
7. Unsuccessful previous attempts at spinal fusion
8. Tumor resection

All components of the LIBERTY™ Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only.

WARNING: This device system is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

V. Mechanical test data were supplied or referenced in support of the LIBERTY™ Anterior Spinal System 510(k) notification. The LIBERTY™ Anterior Spinal System was declared to be substantially equivalent to other commercially available devices.

© 1997 Sofamor Danek