TRITIUM STERNAL CABLE PLATE SYSTEM

K133785 · Pioneer Surgical Technology, Inc. · JDQ · Jan 27, 2014 · Orthopedic

Device Facts

• Record ID: K133785
• Device Name: TRITIUM STERNAL CABLE PLATE SYSTEM
• Applicant: Pioneer Surgical Technology, Inc.
• Product Code: JDQ · Orthopedic
• Decision Date: Jan 27, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer Sternal Cable Plate 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 Cable Plate System consists of titanium plates, integrated cables, crimps, and self-drilling screws (Ø2.7mm and 3.0mm). Device used for anterior chest wall and sternal repair/reconstruction. Implanted via open or minimally invasive approach by surgeons using manual orthopedic instruments. System provides mechanical stabilization of bone segments; output is physical fixation of the sternum or chest wall. Benefits include structural support for healing fractures or post-surgical reconstruction.

Clinical Evidence

Bench testing only. Static and dynamic tensile tests were performed to demonstrate mechanical performance equivalent to predicate systems.

Technological Characteristics

Materials: ASTM F67 Grade IV commercially pure titanium and ASTM F136 Titanium alloy. Components: Plates, integrated cables, crimps, and self-drilling screws (8-20mm lengths). Mechanical fixation device.

Indications for Use

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

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• Pioneer Sternal Cable System (K122293)
• Biomet SternaLock Blu Microfixation Sternal Closure System (K110574)
• Ethicon Wire (K946173)

Submission Summary (Full Text)

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| | 510(k) Summary Pursuant to 21 CFR 807.92<br>JAN : 2 | |
|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Sponsor: | Pioneer Surgical Technology, Inc.<br>(RTI Surgical, Inc.)<br>375 River Park Circle<br>Marquette, MI 49855 USA<br>Contact: Emily Downs, Sarah McIntyre<br>Ph: [phone]<br>Fx: [phone]<br>Prepared: January 2, 2014 | |
| Name: | Pioneer Sternal Cable Plate System | |
| Trade names: | Tritium | |
| Common name: | Pioneer Sternal Cable Plate System | |
| Classifications: | §888.3010 Cerclage, Fixation, Metallic<br>§888.3030 Plate. Fixation. Bone, Non-Spinal, Metallic<br>§888.3040 Screw. Fixation. Bone. Non-Spinal, Metallic | |
| Product Codes: | JDQ, HRS, HWC | |
| Panel/ Branch: | Orthopaedic and Rehabilitation Devices Panel: Panel Code 87 | |
| Predicates: | Pioneer Sternal Cable System (K122293)<br>Biomet SternaLock Blu Microfixation Sternal Closure System (K110574)<br>Ethicon Wire (K946173) | |
| Description: | The Pioneer Sternal Cable Plate System contains various configurations of<br>plates, some with integrated cables and crimps, and Ø2.7mm and 3.0mm<br>self-drilling screws (lengths 8-20mm) to allow for multiple anterior chest<br>wall and sternal repair and reconstruction options. The implants are<br>manufactured from medical grade ASTM F67 Grade IV commercially pure<br>titanium and ASTM F136 Titanium alloy. | |
| | The implants may be implanted via an open or minimally invasive<br>approach using Class I (exempt) orthopedic manual surgical instruments. | |
| | The purpose of this submission is to add additional implant configurations<br>to the system. | |

#### it to 21 CFR 807.92 510/L) St Pursual

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- The Pioneer Sternal Cable Plate System is intended for use in the Intended Use: stabilization and fixation of fractures of the anterior chest wall including Sternal fixation following Sternotomy and Sternal reconstructive surgical procedures.
Static and Dynamic Tensile Tests were provided to support that the Pre-Clinical Pioneer Sternal Cable Plate System performs in a manner substantially Performance Data: equivalent to that of predicate systems. No new issues of safety or effectiveness were raised.

Substantial This submission supports the position that the subject system is Equivalence substantially equivalent to previously cleared systems. The subject and predicate systems are similar in terms of indications for use, material composition, sterilization, packaging, technological characteristics, design features, and mechanical strength.

> There are no significant differences between the subject system and the predicates which would adversely affect the use of the product. Any differences were not considered significant based on mechanical bench testing.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

## January 27, 2014

Pioneer Surgical Technology, Incorporated (RTI Surgical, Incorporated) Ms. Emily Downs Director of Regulatory and Clinical Affairs 375 River Park Circle Marquette, Michigan 49855

Re: K133785

Trade/Device Name: Pioneer Sternal Cable Plate System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ, HRS, HWC Date: January 2, 2014 Received: January 3, 2014

## Dear Ms. Downs:

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. Emily Downs

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Vincent Devlin -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K133785

### Device Name

Pioneer Sternal Cable Plate System

## Indications for Use (Describe)

The Pioneer Sternal Cable Plate 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.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

| SC | Indilishing Services ( 101) 443-6740

EF

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Elizabet阿姆Frank -S

Division of Orthopedic Devices

FORM FDA 3881 (9/13)

See PRA Statement on last page.

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013