SPINAL CONCEPTS, INC. INFIX SYSTEM

K031672 · Spinal Concepts, Inc. · MQP · Aug 7, 2003 · Orthopedic

Device Facts

• Record ID: K031672
• Device Name: SPINAL CONCEPTS, INC. INFIX SYSTEM
• Applicant: Spinal Concepts, Inc.
• Product Code: MQP · Orthopedic
• Decision Date: Aug 7, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InFix System is a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). InFix is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The InFix is intended to be used with bone graft.

Device Story

InFix System is a vertebral body replacement device for thoracic/thoracolumbar spine (T3-L5). Device consists of two titanium 6AL-4V alloy endplates and adjustable vertical struts; includes optional UHMWPE end cap to contain bone graft. Surgeon implants device into space created by vertebrectomy to restore spinal column biomechanical integrity. Titanium endplates feature holes for bone in-growth and angled spikes for fixation/migration resistance. Struts incorporate load-sharing mechanism to manage strain across fusion mass. Used by surgeons in clinical settings for tumor or trauma-related vertebral instability.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Materials: Titanium 6AL-4V alloy (ASTM F-136) and UHMWPE. Design: Two-piece endplate system with adjustable vertical struts. Fixation: Angled spikes on endplates. Load management: Integrated load-sharing mechanism. Connectivity: None (mechanical implant). Sterilization: Not specified.

Indications for Use

Indicated for patients requiring vertebral body replacement in the thoracic and/or thoracolumbar spine (T3-L5) following partial or total vertebrectomy due to tumor or trauma (fracture). Intended for use with bone graft.

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.

Predicate Devices

• Interpore Cross GEO™ Structure (K010530)
• Interpore Cross GEO™ Structure (K020048)
• Interpore Cross International Anterior Fixation Device (AFD) (K022143)

Submission Summary (Full Text)

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AUG - 7 2003

**K031672**

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## 510(K) Summary

| Submitted By: | Lisa Peterson |
|----------------------|------------------------------------|
| | Regulatory Affairs Specialist |
| | Spinal Concepts, Inc. |
| | 5301 Riata Park Court, Bldg. F |
| | Austin, TX 78727 |
| | 512-918-2700 |
| Date: | May 29, 2003 |
| Trade Name: | Spinal Concepts Inc. InFix® System |
| Classification Name: | Vertebral Body Replacement |
| Product Code: | MQP |

Predicate Devices: InFix® is substantially equivalent to the Interpore Cross GEO™ Structure. which was cleared as an oval shaped configuration on August 3, 2001 (K010530) and as a rectangular shaped configuration on February 6, 2002 (K020048) and Interpore Cross International Anterior Fixation Device (AFD) cleared on January 23, 2003 (K022143).

Device Description: InFix® is manufactured from implantable grade titanium 6AL-4V alloy that conforms to ASTM F-136, and is available in various sizes and dimensions. The device is comprised of two opposing endplates supported by vertical members or "struts" that can be varied in height such that the surgeon can fix the vertebrae in a proper anatomical alignment and lordosis.

Each of the struts includes a load-sharing mechanism that allows a limited amount of strain across the fusion mass while supporting the load bearing surfaces. An Ultra High Molecular Weight Polyethylene (UHMWPE) end cap may be placed inside the device prior to packing of bone graft to effectively block the posterior opening in the device and contain the material inside.

Holes in the titanium endplates provide space for bone in-growth while angled spikes (teeth) penetrate the vertebral endplates and provide resistance to rotation and migration.

The InFix System is a vertebral body replacement device intended for use in the Intended Use: thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). InFix is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The InFix is intended to be used with bone graft.

Substantial Equivalence: Mechanical testing demonstrates that InFix® is substantially equivalent to the Interpore Cross GEO™ Structure and Interpore Cross International Anterior Fixation Device (AFD)predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

AUG - 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Peterson Regulatory Affairs Specialist Spinal Concepts Incorporated 5301 Riata Park Court, Bldg. F Austin, Texas 78727

> K031672 Trade Name: InFix® System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: May 29, 2003 Received: June 5, 2003

Dear Ms. Peterson:

Re:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Lisa Peterson

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of vour device to a legally marketed predicate device results in a classification for your device and thus. permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K031672

Device Name:

Spinal Concepts, Inc. InFix® System

Indications for Use:

The InFix System is a vertebral body replacement device intended for use in the thoracic and/or thoracolumbar spine (T3 - L5) to replace a collapsed, damaged or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).

InFix is designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period.

The InFix is intended to be used with bone graft.

Wlf

(Division Sign-Off) Division of Gerenal, Restorative and Neurological Devices

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE SHUANNING PAGE | | O2/ // 7 2 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

v Prescription Use: (Per 21 CFR 801.109)

OR

Over-The-Counter: (Optional Format 1-2-96)