STALIF TT

K051027 · Surgicraft , Ltd. · MQP · Jun 29, 2005 · Orthopedic

Device Facts

• Record ID: K051027
• Device Name: STALIF TT
• Applicant: Surgicraft , Ltd.
• Product Code: MQP · Orthopedic
• Decision Date: Jun 29, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is intended for use as a vertebral body replacement or partial replacement in the thoracolumbar spine (from T9 to L5). The STALIF™ TT device may be used with bone graft.

Device Story

STALIF TT is a radiolucent vertebral body replacement device; used for thoracolumbar (T9-L5) reconstruction following vertebrectomy or corpectomy. Input: surgical site requiring structural support. Operation: device provides anterior column support; restores planar alignment and vertebral height; facilitates neural decompression. Used in clinical settings by surgeons; implanted to restore biomechanical integrity of spinal column. May be used with bone graft. Benefit: immediate and prolonged structural support for patients with spinal tumors or traumatic fractures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: PEEK-OPTIMA LT1. Radiolucent vertebral body replacement system. Includes cancellous bone screws. Designed for thoracolumbar (T9-L5) application.

Indications for Use

Indicated for patients requiring vertebral body replacement, partial vertebrectomy, or augmentation due to vertebral destruction from tumor or fracture/trauma in the thoracolumbar spine (T9-L5).

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

• DePuy AcroMed Stackable Cage™ System
• Interpore Cross International GEO Structure

Submission Summary (Full Text)

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# JUN 2 9 2005

# PREMARKET NOTIFICATION 510(K) SUMMARY

# STALIF TT™ SYSTEM

| Company: | Surgicraft, LTD<br>8 Padgets Lane<br>South Moons Moat<br>Redditch, United Kingdom<br>B98 ORA |
|----------|----------------------------------------------------------------------------------------------|
|----------|----------------------------------------------------------------------------------------------|

Steve Trotman Contact:

Proposed Proprietary Trade Name:

STALIF™ TT

888.3060 Orthopedics Classification Name:

FDA Product Code MQP, Class II Classification:

#### Device Description:

The Surgicraft STALIF™ TT is a radiolucent vertebral body replacement device used in coniunction with cancellous bone screws and is designed to restore biomechanical integrity from thoracic (T9 to T12) and lumbar spine (L1 to L5) following vertebrectomy or corpectomy for patients with spine tumors or traumal fracture. The system provides anterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion.

#### Material:

PEEK-OPTIMA LT1

## Intended Use:

The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is intended for use as a vertebral body replacement or partial replacement in the thoracolumbar spine (from T9 to L5). The STALIF™ TT device may be used with bone graft.

| Predicate Device: | DePuy AcroMed Stackable Cage™ System<br>Interpore Cross International GEO Structure |
|--------------------------|-------------------------------------------------------------------------------------|
| Substantial Equivalence: | Performance data were provided. |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

JUN 2 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgicraft L.T. D. C/o Ms. Janet M. Webb MEDVantage Incorporated 950 N. Michigan Avenue #2202 Chicago, Illinois 60611

Re: K051027

Trade/Device Name: STALIF TT Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: June 13, 2005 Received: June 14, 2005

Dear Ms. Webb:

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. Janet M. Webb

This letter will allow you to begin marketing your device as described in your Section 510(k) rins letter with and yourse FDA finding of substantial equivalence of your 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/industry/support/index.html.

Sincerely yours,

A. Styet Rhodes

C. Provost, Ph.D. Acting 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

510(k) Number (if known): K051027 Device Name: STALIF TT TM Indications for Use:

The STALIF™ TT device is indicated for the replacement, partial vertebrectomy and / or augmentation of a vertebral body due to destruction or partial destruction by tumor or fracture/trauma leading to the restoration of planar alignment, restoration of the height of the collapsed vertebral body and indirectly facilitating neural decompression. The device is designed to restore biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. The device is intended for use as a vertebral body replacement or partial replacement in device is intendou for Good a Torestial book ropacement of partice may be used with bone graft.

or Over-The-Counter Use ______________________________________________________________________________________________________________________________________________________ Prescription Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hypt. Durden

(Divisio Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________