TAMARACK ANTERIOR THORACOLUNBAR

K050390 · Alphatec/Nexmed · KWQ · Mar 14, 2005 · Orthopedic

Device Facts

• Record ID: K050390
• Device Name: TAMARACK ANTERIOR THORACOLUNBAR
• Applicant: Alphatec/Nexmed
• Product Code: KWQ · Orthopedic
• Decision Date: Mar 14, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TAMARACK™ Anterior Thoracolumbar Plating System is intended for fixation to the anterolateral vertebral bodies (T10 to L5). This system is intended for implantation on one side only for the treatment of thoracic and lumbar spine instability as a result of fracture, including dislocation and subluxation, tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous fusion surgery.

Device Story

TAMARACK™ Anterior Thoracolumbar Plating System provides temporary internal fixation and stabilization for spinal deformities during bone graft healing or fusion. System components include plates, screws, bolts, and locking nuts. Used by surgeons in clinical settings for anterolateral vertebral body fixation (T10-L5). Device acts as mechanical support to stabilize spine segments. Benefits include maintaining alignment and facilitating fusion in patients with instability from fractures, tumors, or degenerative conditions. Not for posterior element fixation.

Clinical Evidence

Bench testing only; static and dynamic mechanical testing performed to demonstrate performance equivalence.

Technological Characteristics

Titanium alloy (Ti 6Al-4V) per ASTM F-136. System includes plates, screws, bolts, and locking nuts. Mechanical fixation device.

Indications for Use

Indicated for patients requiring fixation to anterolateral vertebral bodies (T10-L5) for thoracic and lumbar spine instability due to fracture, tumor, degenerative disc disease, scoliosis, kyphosis, lordosis, spinal stenosis, or failed fusion. Contraindicated for fixation to posterior elements (pedicle) of 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.

Predicate Devices

• Z-Plate (K991460)

Submission Summary (Full Text)

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K050390

# TAMARACK™ Anterior Thoracolumbar Plating System 510(k) SUMMARY February 2005

MAR - 1 2005

- Alphatec Manufacturing Inc. 1. Company: 6110 Corte Del Cedro Carlsbad, CA 92009, USA [phone]
- Ellen Yarnall, Director of Regulatory Affairs ll Contact Person:
- Trade/Proprietary Name: TAMARACK™ Anterior Thoracolumbar Plating System 111

#### Product Description: IV

The TAMARACK™ Anterior Thoracolumbar Plating System facilitates the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. Device implants include a range of sizes of plates, screws, bolts and a locking nut. All system components are made from titanium alloy (Ti 6Al-4V) meeting ASTM F-136.

#### V. Classification

KWQ (21 CFR 888.3060) Spinal Intervertebral Body Fixation Orthosis

### VI Indications for Use

The TAMARACK™ Anterior Thoracolumbar Plating System is intended for fixation to the anterolateral vertebral bodies (T10 to L5). This system is intended for implantation on ane side only for the treatment of thoracic and lumbar spine instability as a result of fracture, including dislocation and subluxation, tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by (adimed as and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous fusion surgery

### Substantial Equivalence: VII

This application demonstrates that the TAMARACK™ Anterior Thoracolumbar Plating System is substantially equivalent to the Z-Plate offered by Medtronic Sofamor Danek. (K991460)

#### VIII Performance Data:

Static and dynamic testing of the TAMARACK™ Anterior Thoracolumbar Plating System was performed and submitted in this application.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2005

Ellen A Yarnall Director of Regulatory Affairs Alphatec Manufacturing, Inc. 6110 Corte Del Cedro Carlsbad, California 92009

Re: K050390

Trade/Device Name: TAMARACK™ Anterior Thoracolumbar Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: February 14, 2005 Received: February 16, 2005

Dear Ms. Yarnell:

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. Ellen A Yarnall

This letter will allow you to begin marketing your device as described in your Section 510(k) I ins lotter will and in your a cella finding of substantial equivalence of your device to a legally prematicated predicated 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 if you desire specific as notiance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain Wher general information on your responsibilities under the Act from the Division of Small other general 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,

Mark A. Melkum

Miriam 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): KOSO390

Device Name: TAMARACK™ Anterior Thoracolumbar Plating System

Indications for Use:

The TAMARACK™ Anterior Thoracolumbar Plating System is intended for fixation to the anterolateral vertebral bodies (T10 to L5). This system is intended for implantation on one side only for the treatment of thoracic and lumbar spine instability as a result of fracture, including dislocation and subluxation, tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous fusion surgery.

Warning: This device is not intended for fixation to the posterior elements (pedicle) of the cervical, thoracic or lumbar spine.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Mulkerson

Division of General, Restorative, and Neurological Devices

510(k) Number K050390

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