ALTES BUTTRESS PLATING SYSTEM

K061482 · Altiva Corp. · KWQ · Jul 26, 2006 · Orthopedic

Device Facts

• Record ID: K061482
• Device Name: ALTES BUTTRESS PLATING SYSTEM
• Applicant: Altiva Corp.
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ALTES Anterior Buttress Plating System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent interverbral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one following motion segment anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

Device Story

ALTES Buttress Plating System consists of titanium alloy plates and screws; designed for anterior spinal fixation. Plates conform to anterior spine anatomy; screws engage vertebral body to prevent rotation; integrated locking mechanism secures plate and screws. Used by surgeons in clinical settings for stabilization and bone graft buttressing following anterior structural reconstruction for degenerative disc disease. Device provides mechanical support to maintain graft position; prevents hardware migration; aids in spinal stabilization.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing.

Technological Characteristics

Constructed from titanium alloy with smooth anodized color-coded finish. System includes plates (20mm, 25mm, 30mm) and screws (4.5mm, 5.0mm diameters; 15mm, 20mm lengths). Features mechanical locking mechanism for screw-plate interface. Non-electronic, mechanical device.

Indications for Use

Indicated for patients with degenerative disc disease (DDD) requiring anterior structural reconstruction at the L1-S1 level. DDD defined as discogenic back pain confirmed by history and radiography. Used for stabilization and buttressing of bone graft over one motion segment.

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.

Submission Summary (Full Text)

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K061482

Altiva ALTESTM Buttress Plating System 510(k) Application

SIOF 2

## PREMARKET NOTIFICATION 510(K) SUMMARY

JUL 26 2005 Company: Altiva Corporation 9800 Suite i, Southern Pines Blvd Charlotte, NC 28273 Telephone: [phone] Fax: [phone] Company Contact: John Kapitan, Director Product Development, RA/QA Date: May 24, 2006 Trade Name: ALTES™ Buttress Plating System Common Name Anterior Lumbar Buttress System Orthopedics, 888.3060, Class II Classification: KWQ

FDA Product Code :

Device Description:

The ALTES™ Anterior Buttress Plating System consists of plates and screws. The plate is shaped to conform to the anatomy of the anterior spine. The system features two screws which engage the vertebral body and prevent rotation. A unique locking mechanism of the screw prevents the plate and screws from releasing. The plates are available in three sizes: 20mm, 25mm. and 30mm. The screws are available in two diameters: 4.5mm and 5.0mm, and two lengths: 15mm and 20mm. The components of the ALTES™ Anterior Buttress Plating System are manufactured from titanium alloy and have a smooth anodized color-coded finish.

## Intended Use:

The ALTES Anterior Buttress Plating System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent interverbral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one following motion segment anterior structural reconstruction for degenerative disc disease (DDD). DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

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Predicate Device:

Predicate device information is included.

Performance Data: Performance data were submitted to characterize the ALTES™ Anterior Buttress Plating System.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. Encircling the caduceus is the text "U.S. Department of Health and Human Services" arranged in a circular pattern.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 26 2006

Altiva Corporation % Mr. John Kapitan Director, RA/QA 9800 Southern Pines Blvd., Suite I Charlotte, NC 28273

Re: K061482

Trade/Device Name: Altiva ALTES™ Buttress Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: May 24, 2006 Received: May 30, 2006

Dear Mr. Kapitan:

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 markcted 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 docs 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 - Mr. John Kapitan

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,

Herbert Lemoncito

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

Enclosure

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## Indication for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Altiva ALTES™ Buttress Plating System

Indications for Use:

The ALTES™ Buttress Plating System is intended for anterior intravertebral body screw fixation/attachment to the L1-S1 spine over one vertebral body extending onto the adjacent interverbral space. Due to variations in the anatomy, the plate is designed for applications caudal to the bifurcation of the great vessels. Specifically, the device is intended for stabilization and buttressing of bone graft over one motion segment following anterior structural reconstruction for degenerative disc disease (DDD), DDD is defined as follows: back pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies.

Prescription Use x or

Over-The-Counter Use

(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 Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Numb