Frontier Medical Devices In-line Orthopedic Cable Cerclage System

K151888 · Frontier Medical Devices, Inc. · JDQ · Oct 30, 2015 · Orthopedic

Device Facts

• Record ID: K151888
• Device Name: Frontier Medical Devices In-line Orthopedic Cable Cerclage System
• Applicant: Frontier Medical Devices, Inc.
• Product Code: JDQ · Orthopedic
• Decision Date: Oct 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The In-Line Orthopedic Cable Cerclage System is intended for use in general orthopedic trauma surgery involving olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction during open reduction internal fixation (ORIF) procedures.

Device Story

System consists of cable and crimp assembly for cerclage fixation of long bone, pelvic, and acetabular fractures; tension band fixation of patella, olecranon, ankle, and shoulder. Used in orthopedic trauma surgery; operated by surgeons. Implants provide mechanical stabilization of bone fragments. Instrumentation facilitates cable tensioning and crimping. Benefits include fracture stabilization and reduction support.

Clinical Evidence

Bench testing only. Static and dynamic mechanical testing demonstrated performance substantially equivalent to predicate systems.

Technological Characteristics

Materials: medical grade titanium alloy (ASTM F 136), unalloyed titanium (ASTM F 67), cobalt chromium alloy (ASTM F 90). System includes cable and crimp assembly with dedicated instrumentation. Provided sterile.

Indications for Use

Indicated for patients requiring orthopedic trauma surgery for fractures of the olecranon, patella, femur, pelvis, acetabulum, humerus, or ankle; acromioclavicular dislocations; prophylactic banding during total joint procedures; or temporary reduction during ORIF.

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

• Synthes Orthopaedic Cable System (K992616)
• Zimmer Cable-Ready Cable Grip System (K935481, K940729, K941213)

Submission Summary (Full Text)

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

October 30, 2015

Frontier Medical Devices, Incorporated Ms. Bethany Byman Director of Regulatory Affairs 512 Fourth Street Gwinn, Michigan 49841

Re: K151888

Trade/Device Name: Frontier Medical Devices In-line Orthopedic Cable Cerclage System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: September 19, 2015 Received: September 21, 2015

Dear Ms. Byman:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education at its toll-free 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" (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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

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) K151888

Device Name

Frontier Medical Devices In-line Orthopedic Cable Cerclage System

Indications for Use (Describe)

The In-Line Orthopedic Cable Cerclage System is intended for use in general orthopedic trauma surgery involving olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction during open reduction internal fixation (ORIF) procedures.

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

| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> </span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> </span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary Pursuant to 21 CFR 807.92

| Sponsor: | Frontier Medical Devices, Inc.<br>512 Fourth Street<br>Gwinn, MI 49841 USA |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Bethany Byman<br>Ph: 906-232-1200<br>Fx: 906-232-1222 |
| | Prepared: July 8, 2015 |
| Trade name: | Frontier Medical Devices In-Line Orthopedic Cable Cerclage System |
| Common name: | Cerclage Cable System |
| Classification: | §888.3010 Cerclage, Fixation, Metallic |
| Product Code: | JDQ |
| Panel/ Branch: | Orthopaedic and Rehabilitation Devices Panel; Panel Code 87 |
| Predicates: | Synthes Orthopaedic Cable System (K992616)<br>Zimmer Cable-Ready Cable Grip System (K935481, K940729,<br>K941213) |
| Description: | The In-Line Orthopedic Cable Cerclage System consists of a cable and<br>crimp assembly to allow cerclage fixation of various long bone, pelvic<br>and acetabular fractures as well as tension band fixation of the patella,<br>olecranon, ankle and shoulder. The implants are manufactured from<br>medical grade titanium alloy per ASTM F 136, unalloyed titanium per<br>ASTM F 67, and cobalt chromium alloy per ASTM F 90. The implants<br>are provided sterile. Instrumentation has been designed for use with<br>this implant system. |
| Intended Use: | The In-Line Orthopedic Cable Cerclage System is intended for use in<br>general orthopedic trauma surgery involving olecranon, patella, femur<br>(including periprosthetic fractures), pelvic, acetabular, humeral, and<br>ankle fractures, acromioclavicular dislocations, prophylactic banding<br>during total joint procedures, and temporary reduction during open<br>reduction internal fixation (ORIF) procedures. |
| Non-Clinical<br>Performance Data: | Static and dynamic testing supports that the In-Line Orthopedic Cable<br>Cerclage System performs in a manner substantially equivalent to that<br>of the predicate system; no new issues of safety or effectiveness were<br>raised. |
| Technological<br>Characteristics: | The In-Line Orthopedic Cable Cerclage System and predicate devices<br>are similar in terms of indications for use, material composition,<br>technological characteristics, design characteristics, and mechanical<br>strength. The minor differences in technological characteristics that<br>do exist do not raise any new types of safety or efficacy issues. |
| Substantial<br>Equivalence: | This submission supports the position that the subject In-Line<br>Orthopedic Cable Cerclage System is substantially equivalent to<br>previously cleared systems. There are no significant differences<br>between the subject system and the predicates which would adversely<br>affect the use of the product. Any differences were not considered<br>significant based on mechanical bench testing. |

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