PIONEER STERNAL ASSIST IMPLANT SYSTEM

K120016 · Pioneer Surgical Technology, Inc. · HRS · Jul 26, 2012 · Orthopedic

Device Facts

• Record ID: K120016
• Device Name: PIONEER STERNAL ASSIST IMPLANT SYSTEM
• Applicant: Pioneer Surgical Technology, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jul 26, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer Sternal Assist Implant System is intended for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Device Story

Pioneer Sternal Assist Implant System consists of implantable PEEK plates used for sternal closure; functions as supplemental fixation for sternotomies and sternal fractures. Used in conjunction with Pioneer Sternal Cable System or USP #5, 6, or 7 stainless steel wire. Device applied by surgeons in clinical/OR settings to stabilize sternum; provides mechanical support to facilitate bone healing. Benefits include improved sternal stability and reduced risk of cut-through compared to traditional wire-only fixation.

Clinical Evidence

Bench testing only. Static and dynamic mechanical testing performed to evaluate strength and cut-through resistance. Engineering analysis conducted to mitigate wear risks. No clinical data provided.

Technological Characteristics

Implantable plates made of PEEK (polyetheretherketone) per ASTM F2026. Used with stainless steel wire or cable systems. Mechanical fixation device; non-powered. Sterilization method not specified.

Indications for Use

Indicated for patients requiring stabilization and fixation of anterior chest wall fractures, including sternal fixation post-sternotomy and sternal reconstructive surgery.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• ACUTE Innovations Acutie Sternal Fixation System (K101170)
• Synthes ZipFix (K110789)
• Pioneer Songer Cable System (K935481)
• Ethicon Stainless Steel Suture Wire (K931271/K946173)

Submission Summary (Full Text)

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K120016

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| 510(k) Summary<br>Sponsor: | Pioneer Surgical Technology<br>375 River Park Circle<br>Marquette, MI 49855<br>[phone]<br>Contact: Sarah McIntyre or Emily Downs<br>Prepared: July 25, 2012 | JUL 26 2012 |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Device Name: | Pioneer Sternal Assist Implant System | |
| Classification: | Class II; JDQ, HRS<br>888.3030 - Plate, Fixation, Bone<br>888.3010 - Bone Fixation Cerclage<br>Panel Code: 87 | |
| Predicate Devices: | K101170 ACUTE Innovations Acutie Sternal Fixation System (SE 9/17/10)<br>K110789 Synthes ZipFix (SE 7/28/11)<br>K935481 Pioneer Songer Cable System (SE 1/26/94)<br>K931271/K946173 - Ethicon Stainless Steel Suture Wire (SE 1/9/95) | |
| Intended Use: | The Pioneer Sternal Assist Implant System is intended for use in the<br>stabilization and fixation of fractures of the anterior chest wall, including<br>sternal fixation following sternotomy and sternal reconstructive surgical<br>procedures. | |
| Description: | The Pioneer Sternal Assist Implant System consists of implantable plates<br>for use with the Pioneer Sternal Cable System or USP #5, 6, or 7 Stainless<br>Steel wire as a supplemental fixation to provide fixation for sternotomies<br>and sternal fractures. The components are made of PEEK<br>(polyetheretherketone) per ASTM F2026.<br>The purpose of this submission is to introduce a new sternal closure system<br>to interstate commerce. | |
| Performance Data: | Static and dynamic testing of the subject device was completed to<br>demonstrate that performance related to strength and cut-through resistance<br>was equivalent to or better than the predicate. Testing and engineering<br>analysis were also provided to mitigate the risk of wear and show that no<br>new issues of safety or effectiveness were raised. | |
| Performance and<br>SE Determination: | Equivalence for the Pioneer Sternal Assist Implant System is based on<br>similarities of intended use, mechanical strength, design, and physical<br>characteristics when compared to predicate devices. Therefore, Pioneer<br>Surgical Technology believes that there is sufficient evidence to conclude<br>that the Pioneer Sternal Assist Implant System is substantially equivalent<br>to existing legally marketed devices. | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a circular seal for the Department of Health & Human Services - USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

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

JUL 26 2012

Pioneer Surgical Technology, Incorporated % Ms. Sarah McIntyre Regulatory Affairs Associate 375 River Park Circle Marquette, Michigan 49855

## Re: K120016

Trade/Device Name: Pioneer Sternal Assist Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single / multiple component metallic bone fixation appliances and accessories

Regulatory Class: Class II Product Code: HRS, JDQ Dated: June 8, 2012 Received: June 12, 2012

## 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 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

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Page 2- Ms. Sarah McIntyre

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/ReportalProblem/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,

Mark N. Melkerson

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

Enclosure

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## 3.0 Indications for Use Statement

510(k) Number (if known): K12 OO) 6

Device Name: Pioneer Sternal Assist Implant System

Indications:

The Pioneer Sternal Assist Implant System is intended for use in the stabilization and fixation of fractures of the anterior chest wall, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use

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Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

And

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

120016 510(k) Number