PACP SYSTEM

K053053 · Pioneer Surgical Technology · KWQ · Nov 16, 2005 · Orthopedic

Device Facts

• Record ID: K053053
• Device Name: PACP SYSTEM
• Applicant: Pioneer Surgical Technology
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 16, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Pioneer Anterior Cervical Plate System consists of metallic plates and screws for anterior cervical spinal fixation. Used by surgeons in clinical settings to stabilize the cervical spine. Device provides mechanical support to facilitate fusion in patients with degenerative, traumatic, or structural spinal conditions. System includes manual surgical instruments for implantation.

Clinical Evidence

Bench testing only.

Technological Characteristics

System comprises plates and screws for spinal fixation. Includes manual surgical instruments. No specific material standards or software/energy components described.

Indications for Use

Indicated for anterior cervical fixation in patients with degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, spinal deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or 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.

Predicate Devices

• PACP - K043066

Submission Summary (Full Text)

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

Pioneer Anterior Cervical Plate System - Special

## Summary of Safety and Effectiveness Information [510(k) Summary]

| SPONSOR: | PIONEER SURGICAL TECHNOLOGY<br>375 River Park Circle<br>Marquette, MI 49855<br>[phone]<br>Contact: Jonathan M. Gilbert |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Pioneer Anterior Cervical Plate System |
| CLASSIFICATION<br>NAME: | Spinal Intervertebral Body Fixation Orthosis,<br>Class II. Product code KWQ. |
| DESCRIPTON | The Pioneer Anterior Cervical Plate System<br>consists of an assortment of plates and<br>screws. The system also contains Class 1<br>manual surgical instruments and cases that<br>are considered exempt from premarket<br>notification. |
| INTENDED USE: | The Pioneer Anterior Cervical Plate System is<br>intended for anterior cervical fixation for the<br>following indications: degenerative disc<br>disease (DDD) (defined as neck pain of<br>discogenic origin with degeneration of the disc<br>confirmed by history and radiographic<br>studies), spondylolisthesis, trauma (i.e.,<br>fracture or dislocation), spinal stenosis,<br>deformities or curvatures (i.e., scoliosis,<br>kyphosis, and/or lordosis), tumor,<br>pseudoarthrosis, and failed previous fusion. |
| PERFORMANCE<br>AND SE<br>DETERMINATION: | Comparisons of device performance data,<br>materials, indications and design/function to<br>predicate devices were provided in making a<br>determination of substantial equivalence. |
| PREDICATE<br>DEVICE(S): | PACP - K043066 |

Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to relate to whether the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. [Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355.))

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

Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized representation of a human figure, with three overlapping profiles facing to the right.

Public Health Service

NOV 1 6 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Jonathan Gilbert Director, Regulatory and Clinical Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855

Re: K053053

Trade/Device Name: Pioneer Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: October 25, 2005 Received: November 7, 2005

Dear Mr. Gilbert:

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 (OS) 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 - Jonathan Gilbert

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 N. Melkerson

Acting Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

K053053

PIONEER ANTERIOR CERVICAL PLATE SYSTEM

The Pioneer Anterior Cervical Plate System is intended for anterior cervical fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

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

Over-The-Counter Use (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 Sign-Off)

Division of Gener and Neurological I

510(k) Number_KoS3

Page 1 of

Pioneer Surgical Technology Special 510(k)

October 25, 2005