ATALIA TITANIUM SURGICAL MESH

K041798 · Us Spinal Technologies, LLC · MQP · Feb 7, 2005 · Orthopedic

Device Facts

• Record ID: K041798
• Device Name: ATALIA TITANIUM SURGICAL MESH
• Applicant: Us Spinal Technologies, LLC
• Product Code: MQP · Orthopedic
• Decision Date: Feb 7, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Atalia Titanium Surgical Mesh is indicated for use in the thoraco-lumbar spine (TI-LS), in cases where one vertebral body has been structurally compromised either by turnor or trauma. The objective is the restoration of anterior column support through introduction of a corpectomy construct in tandem is the graft to ultimately realize spinal fusion. The Atalia Titanium Surgical Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and/or lumbar spine.

Device Story

Atalia Titanium Surgical Mesh is a round-patterned, surgical mesh device for vertebral body replacement. Used in thoraco-lumbar spine procedures to restore anterior column support following corpectomy; requires concurrent use of bone graft and supplemental internal spinal fixation systems. Device is non-sterile; allows incremental adjustment of angle and length to match patient anatomy. Operated by surgeons in clinical/OR settings. Provides structural support to facilitate spinal fusion.

Clinical Evidence

Bench testing only. Device tested in accordance with ASTM F2077.

Technological Characteristics

Round-patterned surgical mesh; material: TI-6AL-4V ELI Alloy (ASTM F 136). Adjustable length and angle. Sold non-sterile. Mechanical testing performed per ASTM F2077.

Indications for Use

Indicated for patients with thoraco-lumbar spine vertebral body structural compromise due to tumor or trauma requiring anterior column support restoration and spinal fusion. Must be used with FDA-cleared supplemental internal spinal fixation systems.

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

• Osteotech VBR (K003155)
• Depuy Acromed Surgical Titanium Mesh (K003043)
• Blackstone Surgical Mesh System (K030744)

Submission Summary (Full Text)

{0}------------------------------------------------

# FEB - 7 7005

041798

# 510(k) Summary

Submitted on behalf of:

U.S. Spinal Technologies, Inc. 3600 FAU Blvd. Ste 101 Boca Raton, FL 33431, USA Telephone: [phone] Fax: [phone]

by:

Elaine Duncan, M.S.M.E., RAC President, Paladin Medical, Inc. PO Box 560 Stillwater, MN 55082 Telephone: [phone] Fax: [phone]

CONTACT PERSON:

Elaine Duncan

| DATE PREPARED: | January 27, 2005 |
|----------------|-------------------------------|
| TRADE NAME: | Atalia Titanium Surgical Mesh |
| COMMON NAME: | vertebral body replacement |

# SUBSTANTIALLY EQUIVALENT TO:

The Atalia Titanium Surgical Mesh is substantially equivalent to various features and performance characteristics to the Osteotech VBR (K003155), the Depuy Acromed Surgical Titanium Mesh (K003043) and the Blackstone Surgical Mesh System (K030744) as detailed in the submission.

## DESCRIPTION of the DEVICE:

The Atalia Titanium Surgical Mesh is a round-patterned, surgical mesh device. The body is manufactured from TI-6AL-4V ELI Alloy conforming to ASTM F 136. Because of the construction, the angle and the length of the mesh can be reduced incrementally to adjust it to individually anstomical conditions. The Atalia Surgical Mesh System is sold non-sterile.

#### INDICATIONS FOR USE:

The Atalia Titanium Surgical Mesh is indicated for use in the thoraco-lumbar spine (TI-LS), in cases where one vertebral body has been structurally compromised either by turnor or trauma. The objective is the restoration of anterior column support through introduction of a corpectomy construct in tandem is the graft to ultimately realize spinal fusion. The Atalia Titanium Surgical Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and/or lumbar spine.

#### SUMMARY of TESTING:

The Atalia Titanium Mesh (U.S. Spinal Technologies) was tested in accordance with ASTM F2077.

Page 1 of 1

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an emblem of a stylized bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 7 2005

U.S. Spinal Technologies, Inc. c/o Ms. Elaine Duncan, M.S.M.E., RAC President Paladin Medical, Inc. P.O. Box 560 Stillwater, Minnesota 55082

Re: K041798

Trade/Device Name: Atalia Titanium Surgical Mesh Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: MQP Dated: December 10, 2004 Received: January 21, 2005

Dear Ms. Duncan:

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 for abounded or 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, ITDA 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.

{2}------------------------------------------------

# Page 2 - Ms. Elaine Duncan, M.S.M.E., RAC

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 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,

Mark A. Millerman

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

{3}------------------------------------------------

# Indications for Use

PRODUCT NAME: Atkin Titanin Surgical Mask

510(k) Number (if known): 1041798

The Atalia Titanium Surgical Mesh is indicated for use in the thoraco-lumbar spine (T1-LS), in cases where one vertebral body has been structurally compromised either by tumor or trauma. The objective is the restoration of anterior column support through introduction of a corpectomy construct in tandem with bone graft to ultimately realize spinal fusion. The Atalia Titanium Surgical Mesh is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and/or lumbar spine.

Prescription Use AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Exaluation (ODE

for
(Division Sign-Off)
Division of General, Restorative,
Page 1 of 1
Neurological Devices

10(k) Number K041798