PACP

K083663 · Pioneer Surgical Technology · KWQ · Feb 25, 2009 · Orthopedic

Device Facts

• Record ID: K083663
• Device Name: PACP
• Applicant: Pioneer Surgical Technology
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 25, 2009
• 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 metal plates and screws for spinal intervertebral body fixation. Used by surgeons in clinical settings to stabilize cervical spine segments. Device provides mechanical support to facilitate fusion in patients with degenerative, traumatic, or structural spinal conditions. System includes manual surgical instruments for implantation. Clinical benefit derived from stabilization of the cervical spine.

Clinical Evidence

No clinical data; substantial equivalence determined via bench testing and comparison of design/materials to predicate devices.

Technological Characteristics

System consists of plates and screws for spinal fixation. Class II medical device. Materials and design characteristics are consistent with previously cleared predicate devices.

Indications for Use

Indicated for patients requiring anterior cervical fixation due to 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 (K053053)
• PACP (K043066)

Submission Summary (Full Text)

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Page 1 of

Date prepared 2/2/09

## FEB 2 5 2009

#### 510(k) Summary

SPONSOR:

PIONEER SURGICAL TECHNOLOGY 375 River Park Circle Marquette, MI 49855 [phone] Contact: Jonathan M. Gilbert

Pioneer Anterior Cervical Plate System

Spinal Intervertebral Body Fixation Orthosis, Class II. Product code KWQ.

The Pioneer Anterior Cervical Plate System consists of an assortment of plates and screws. The system also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

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.

Comparisons of device performance data, materials, indications and design/function to predicate devices were provided in making a determination of substantial equivalence.

PACP - K053053 PACP - K043066

DEVICE NAME:

CLASSIFICATION NAME:

DESCRIPTON

#### INTENDED USE:

## PERFORMANCE AND SE DETERMINATION:

#### PREDICATE DEVICE(S):

•

K083663

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. In the center of the seal is an emblem featuring an eagle with its wings spread, clutching a staff entwined with a serpent.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## PIONEER SURGICAL TECHNOLOGY % Mr. Jonathan M. Gilbert 375 River Park Circle Marquette, Michigan 49855

B 2 5 2009

Re: K083663

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: February 2, 2009 Received: February 3, 2009

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 (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. Jonathan M. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Pelin D. R
DLP D.S.R

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 1 of 1

# Indications for Use

510(k) Number (if known):

Device Name:

Indications For Use:

## K08 3663

# PIONEER ANTERIOR CERVICAL PLATE SYSTEM

The Pioneer Anterior Cervical Plate System is inteinded 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 (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 Si. Com

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

22 (10)

510(k) Number