PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM

K113218 · Pioneer Surgical Technology, Inc. · NQW · Jan 26, 2012 · Orthopedic

Device Facts

• Record ID: K113218
• Device Name: PIONEER RELEASE LAMINOPLASTY PLATING SYSTEM
• Applicant: Pioneer Surgical Technology, Inc.
• Product Code: NQW · Orthopedic
• Decision Date: Jan 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer Release Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Pioneer Release Laminoplasty Plating System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.

Device Story

Pioneer Release Laminoplasty Plating System consists of implantable titanium alloy plates and screws; acts as buttress to maintain decompression after laminoplasty. Used in lower cervical and upper thoracic spine (C3-T3) to hold graft material in place; prevents graft expulsion or spinal cord impingement. System includes manual surgical instruments. Operated by surgeons in clinical/surgical settings. Provides mechanical stabilization of graft material; benefits patient by maintaining spinal decompression and protecting spinal cord.

Clinical Evidence

Bench testing only. Static and fatigue four-point bend testing per ASTM F2193 and axial screw pull-out testing per ASTM F543 were performed to demonstrate mechanical performance and substantial equivalence.

Technological Characteristics

Components manufactured from biocompatible, implant-grade ASTM F136 titanium alloy. System includes plates and screws. Mechanical fixation principle. No software or energy source.

Indications for Use

Indicated for patients undergoing laminoplasty procedures in the lower cervical and upper thoracic spine (C3 to T3) to secure graft material and prevent expulsion or spinal cord impingement.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Mountaineer Laminoplasty System (K091994)
• CENTERPIECE Plate Fixation System (K050082)

Submission Summary (Full Text)

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长川多218

JAN 2 6 2012

## 4.0 510(k) Summary

| Sponsor: | Pioneer Surgical Technology<br>375 River Park Circle<br>Marquette, MI 49855<br>[phone]<br>Contact: Sarah McIntyre or Emily Downs<br>Prepared: October 28, 2011 |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Pioneer Release Laminoplasty Plating System |
| Classification: | Class II; NQW/ 888.3050 - Spinal interlaminal fixation orthosis<br>Panel Code: 87 |
| Predicate Devices: | K091994 DePuy Spine, Inc. Mountaineer Laminoplasty System (SE 1/7/10)<br>K050082 Medtronic CENTERPIECE Plate Fixation System (SE 6/6/05) |
| Description: | The Pioneer Release Laminoplasty Plating System consists of implantable plates<br>and screws that will act as a buttress to maintain decompression after a<br>laminoplasty procedure. The system also contains Class 1 manual surgical<br>instruments and cases that are considered exempt from premarket notification. |
| Intended Use: | The Pioneer Release Laminoplasty Plating System is intended for use in the lower<br>cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The<br>Pioneer Release Laminoplasty Plating System is used to hold the graft material in<br>place in order to prevent the graft material from expulsion, or impinging the spinal<br>cord. |
| Material: | The Pioneer Release Laminoplasty Plating System components are manufactured<br>from biocompatible, implant grade ASTM F136 titanium alloy. |
| Performance Data: | Static and fatigue four point bend standard testing per recognized ASTM F2193<br>and axial screw pull-out per ASTM F543 standards were performed to establish<br>substantial equivalence. The test results demonstrate that the Pioneer Release<br>Laminoplasty Plating System functioned as intended and performed in a manner<br>substantially equivalent to that of a predicate system. |
| Performance and<br>SE Determination: | Equivalence for the Pioneer Release Laminoplasty Plating System is based on<br>similarities of intended use, design, and physical characteristics when compared to<br>predicate devices. Therefore, Pioneer Surgical Technology believes that there is<br>sufficient evidence to conclude that the Pioneer Release Laminoplasty Plating<br>System is substantially equivalent to existing legally marketed devices. |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a traditional symbol of medicine, with three intertwined strands. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the caduceus symbol. The logo is simple and recognizable, and it is often used on official documents and websites related to the U.S. Department of Health & Human Services.

## Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JAN 2 6 2012

Pioneer Surgical Technology, Inc. % Ms. Sarah McIntyre 375 River Park Circle Marquette, Michigan 49855

Re: K113218

Trade/Device Name: Pioneer Release Laminoplasty Plating System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: October 28, 2011 Received: November 01, 2011

Dear Ms. McIntyre:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 - Ms. Sarah McIntyre

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

for Bott Dasolin Dik

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

Enclosure

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## Indications for Use Statement 3.0

KII 3218 510(k) Number (if known):

Device Name:

Pioneer Release Laminoplasty Plating System

Indications:

The Pioneer Release Laminoplasty Plating System is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures. The Pioneer Release Laminoplasty Plating System is used to hold the graft material in place in order to prevent the graft material from expulsion, or impinging the spinal cord.

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

KII3218 510(k) Number.