PIONEER LUMBAR PLATE SYSTEM

K090222 · Pioneer Surgical Technology · KWQ · Apr 28, 2009 · Orthopedic

Device Facts

• Record ID: K090222
• Device Name: PIONEER LUMBAR PLATE SYSTEM
• Applicant: Pioneer Surgical Technology
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 28, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer Lumbar Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The Pioneer Lumbar Plate System is indicated as an adjunct to fusion in the treatment of lumbar and lumbosacral (LI -S1) spine instability as a result of the following: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, and failed previous spine surgery. Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Story

Pioneer Lumbar Plate System; spinal intervertebral body fixation orthosis. System comprises titanium alloy (Ti6Al4V) plates and screws. Used by surgeons in clinical settings for lumbar/lumbosacral stabilization as adjunct to fusion. Implanted via lateral, anterolateral, or anterior surgical approaches. Provides mechanical stabilization to spine segments. Not for posterior pedicle fixation.

Clinical Evidence

Bench testing only. Mechanical testing conducted in accordance with FDA Guidance for Spinal Systems (2004) to demonstrate substantial equivalence.

Technological Characteristics

Materials: Titanium alloy Ti6Al4V (ISO 5832-3) ELI. Components: Plates and screws. Fixation: Intervertebral body. Approach: Lateral, anterolateral, or anterior. Regulatory Class: II. Product Code: KWQ.

Indications for Use

Indicated for patients requiring lumbar/lumbosacral (L1-S1) spinal fusion due to instability from fracture, tumor, degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities, spinal stenosis, or failed previous surgery. Contraindicated for posterior element (pedicle) fixation.

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

• K063158
• K041167

Submission Summary (Full Text)

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K090222

## Summary of Safety and Effectiveness Information . 3.0

| Sponsor: | Pioneer Surgical Technology<br>APR 2 8 2009<br>375 River Park Circle<br>Marquette, MI 49855<br>[phone]<br>Contact: Jonathan M. Gilbert |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Pioneer Lumbar Plate System |
| Classification Name: | Spinal Intervertebral Body Fixation Orthosis |
| Classification Number: | Regulation Number: 888.3060<br>Product Code: KWQ; Panel Code: 87 |
| Description: | The Pioneer Lumbar Plate System consists of an assortment of<br>plates and screws. The system also contains Class 1 manual<br>surgical instruments and cases that are considered exempt from<br>premarket notification. Implants are composed of titanium alloy<br>Ti6Al4V (ISO 5832-3) ELI, the same as predicate device. |
| Intended Use: | The Pioneer Lumbar Plate System is intended for use via the<br>lateral or anterolateral surgical approach above the bifurcation of<br>the great vessels or via the anterior surgical approach, below the<br>bifurcation of the great vessels. The Pioneer Lumbar Plate<br>System is indicated as an adjunct to fusion in the treatment of<br>lumbar and lumbosacral (LI -S1) spine instability as a result of<br>the following: fracture (including dislocation and subluxation),<br>tumor, degenerative disc disease (defined as back pain of<br>discogenic origin with degeneration of the disc confirmed by<br>patient history and radiographic studies), pseudoarthrosis,<br>spondylolysis, spondylolisthesis, scoliosis, lordotic deformities<br>of the spine, spinal stenosis, and failed previous spine surgery.<br>Warning: This device is not intended for screw attachment or<br>fixation to the posterior elements (pedicles) of the cervical,<br>thoracic, or lumbar spine. |
| Performance Data:<br>Performance and SE<br>Determination: | Mechanical testing in accordance with the "Guidance for<br>Industry and FDA Staff. Guidance for Spinal Systems 510(k')s",<br>May 3, 2004 is presented.<br>Comparisons of device performance data, materials, indications<br>and design/function to predicate devices, K063158 &K041167,<br>were provided in making a determination of substantial<br>equivalence. |

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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, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pioneer Surgical Technology % Mr. Jonathan M. Gilbert 375 River Park Circle Marquette, Michigan 49855

APR 2 8 2009

Re: K090222

Trade/Device Name: Pioneer Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: March 13, 2009 Received: March 16, 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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Mabel N. Malloy

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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## Indications: 2.0 Indications for Use Statement

Pioneer Lumbar Plate System

510(k) Number (if known): K090222

Device Name:

Indications:

The Pioneer Lumbar Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. The Pioneer Lumbar Plate System is indicated as an adjunct to fusion in the treatment of lumbar and lumbosacral (LI -S1) spine instability as a result of the following: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, and failed previous spine surgery.

Warning: This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Mavare Richards A. MKM
Division Sign-Off

Division of General. Hestorative. and Neurological Devices

**510(k) Number** K090220