ALTIVA CLASSIC ACP SYSTEM

K070891 · Altiva Corp. · KWQ · Jun 11, 2007 · Orthopedic

Device Facts

• Record ID: K070891
• Device Name: ALTIVA CLASSIC ACP SYSTEM
• Applicant: Altiva Corp.
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 11, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Altiva Classic ACP System is intended for anterior screw fixation to the cervical spine (C2 to C7). The system is intended for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined by kyphosis, lordosis, or scoliosis), pseudoarthrosis, and failed previous fusion.

Device Story

Altiva Classic ACP System is an anterior cervical screw fixation system; consists of titanium alloy plates and screws. Used by surgeons in clinical settings for temporary stabilization of anterior cervical spine during fusion procedures. Implants provided clean and non-sterile; require sterilization by user. Device provides mechanical support to spine; facilitates fusion process in patients with degenerative, traumatic, or deformity-related spinal conditions. Output is physical stabilization of spinal segments.

Clinical Evidence

Bench testing only.

Technological Characteristics

Titanium alloy plates and screws; anterior cervical fixation; provided clean and non-sterile; requires sterilization.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization (C2-C7) during fusion. Conditions include degenerative disc disease, spondylolisthesis, trauma (fractures/dislocations), tumors, deformity (kyphosis, lordosis, scoliosis), pseudoarthrosis, and failed previous fusion.

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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K070891

# JUN 1 1 2007

## PREMARKET NOTIFICATION 510(K) SUMMARY

| Company: | Altiva Corporation<br>9800 Suite i, Southern Pines Blvd<br>Charlotte, NC 28273<br>Telephone: [phone]<br>Fax: [phone] |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | John Kapitan<br>Vice President, Product Development and RA/QA |
| Date: | March 27, 2007 |
| Trade Name: | Altiva® Classic ACP System |
| Common Name | Spinal Intervertebral Fixation Orthosis |
| Classification: | Orthopedics, 888.3060, Class II |
| FDA Product Code : | KWQ |
| Device Description: | The Altiva Classic ACP System is an anterior screw<br>fixation system for the cervical spine. It includes<br>titanium alloy plates and screws which are provided<br>clean and non-sterile. Various sizes of the implants are<br>provided. |
| Intended Use: | The Altiva Classic ACP System is intended for anterior<br>screw fixation to the cervical spine (C2 to C7). The<br>system is intended for use in the temporary stabilization<br>of the anterior spine during the development of cervical<br>spinal fusion in patients with degenerative disc disease<br>(as defined by neck pain of discogenic origin with<br>degeneration of the disc confirmed by patient history<br>and radiographic studies), spondylolisthesis, trauma<br>(i.e. fractures or dislocations), tumors, deformity<br>(defined by kyphosis, lordosis, or scoliosis),<br>pseudoarthrosis, and failed previous fusion. |
| Predicate Device: | Predicate device information is included. |
| Performance Data: | Performance data were submitted to characterize the<br>Altiva Classic ACP System. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, facing left. The eagle is composed of three curved lines that form the body, wings, and tail feathers. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Altiva Corporation % Mr. John Kapitan VP, Product Development, RA/QA 9800 Southern Pines Boulevard Charlotte, North Carolina 28273

JUN 1 1 2007

Re: K070891

Trade/Device Name: Altiva® Classic ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 26, 2007 Received: March 30, 2007

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 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 – 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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours

for

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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### Page 3 – Mr. John Kapitan

cc: HFZ-401 DMC IIFZ-401 DMC
HFZ-404 510(k) Staff HFZ- Division D.O. f/t:SJB:afb:6/4/07

OC Numbers:

| Division of Enforcement A | 240-276-0115 |
|-----------------------------------------------------------|--------------|
| Dental, ENT and Ophthalmic Devices Branch | 240-276-0115 |
| OB/GYN, Gastro. & Urology Devices Branch | 240-276-0115 |
| General Hospital Devices Branch | 240-276-0115 |
| General Surgery Devices Branch | 240-276-0115 |
| Division of Enforcement B | 240-276-0120 |
| Cardiovascular & Neurological Devices Branch | 240-276-0120 |
| Orthopedic, Physical Medicine & Anesthesiology Devices Br | 240-276-0120 |

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:

and the comments of the comments of

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#### Indication for Use Statement

510(k) Number (if known): 长070891

Device Name: Altiva® Classic ACP System

Indications for Use:

The Altiva Classic ACP System is intended for anterior screw fixation to the cervical spine (C2 to C7). The system is intended for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with:

- degenerative disc disease (as defined by neck pain of discogenic . origin with degeneration of the disc confirmed by patient history and radiographic studies),
- spondylolisthesis, ●
- trauma (i.e. fractures or dislocations), .
- tumors, .
- deformity (defined by kyphosis, lordosis, or scoliosis), .
- pseudoarthrosis, and .
- failed previous fusion. .

Prescription Use × 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)

Mok

Division of General, Restorative, and Neurological Devices

510(k) Number.