Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables

K151907 · Zimmer, Inc. · KTT · Dec 30, 2015 · Orthopedic

Device Facts

• Record ID: K151907
• Device Name: Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables
• Applicant: Zimmer, Inc.
• Product Code: KTT · Orthopedic
• Decision Date: Dec 30, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cable-Ready GTR System: The Cable-Ready GTR System is indicated for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally, the device is used to reattach the greater trochanter following fracture of the greater trochanter, nonunion of fracture, or previous osteotomy. Cable-Ready 1.8mm Cerclage Cables: The 1.8mm cerclage cable can be used to secure fractures of the olecranon, patella, femur, humerus, and ankle, as well as to reduce and secure acromioclavicular dislocations. The 1.8mm cables can also be used to reattach the greater trochanter after trochanteric osteotomy during total hip arthroplasty.

Device Story

System comprises GTR devices and 1.8mm cobalt chrome alloy cerclage cables; used for bone fixation and stabilization. GTR devices feature two upper prongs for looping around greater trochanter and two lower fins to prevent migration/rotation. Cables used with GTR devices or independently to secure fractures. Operated by orthopedic surgeons in clinical/surgical settings. Provides mechanical stabilization of bone segments; aids healing by maintaining alignment of fractured or osteotomized bone. Benefits include secure fixation and reduced risk of implant migration.

Clinical Evidence

No clinical data provided. Substantial equivalence established via non-clinical performance testing, including shelf-life accelerated aging, biocompatibility testing per ISO 10993-1, construct fatigue testing for the GTR system, and engineering analysis for the cerclage cables.

Technological Characteristics

Materials: Cobalt chrome alloy and stainless steel. Design: GTR devices include upper prongs and lower anti-migration fins. 1.8mm cerclage cables. Sterilization: Sterile. Biocompatibility: Tested per ISO 10993-1.

Indications for Use

Indicated for patients requiring greater trochanter reattachment post-osteotomy or fracture (including nonunion) in total hip arthroplasty, and for patients requiring fixation of olecranon, patella, femur, humerus, or ankle fractures, or reduction/fixation of acromioclavicular dislocations.

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

• Pioneer System GTR (Greater Trochanter Reattachment) (K961267)
• Extended GTR Device (K000734)
• Songer Cable System (K935481)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or movement.

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

December 30, 2015

Zimmer, Incorporated Ms. Dalene Binkley Senior Specialist. Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46580

Re: K151907

Trade/Device Name: Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDQ Dated: December 14, 2015 Received: December 15, 2015

Dear Ms. Binkley:

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 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/ResourcesforYou/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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K151907 Page 1 of 2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

Cable-Ready® Cable Grip System: Cable-Ready® GTR System

Indications for Use (Describe)

Cable-Ready® GTR System - The Cable-Ready® GTR System is indicated for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally; the device is used to reattach the greater trochanter following fracture of the greater trochanter, nonunion of fracture, or previous osteotomy.

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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

Cable-Ready® Cable Grip System: Cable-Ready®1.8mm Cerclage Cables

Indications for Use (Describe)

Cable-Ready® 1.8mm Cerclage Cables - The 1.8mm cerclage cable can be used to secure fractures of the olecranon, patella, femur, humerus, and ankle, as well as to reduce and secure acromioclavicular dislocations. The 1.8mm cables can also be used to reattach the greater trochanteric osteotomy during total hip arthroplasty.

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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

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#### 510(k) Summary

| Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene Binkley, MS, RAC<br>Senior Specialist, Trauma Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | July 10, 2015 |
| Trade Name: | This is a bundled traditional 510(k). The two systems<br>bundled in this submission are: |
| | Cable-Ready® Cable Grip System: |
| | 1) Cable-Ready GTR System<br>2) Cable-Ready 1.8mm Cerclage Cables |
| Common Name: | Single/multiple component metallic bone fixation<br>appliance and accessories and cerclage, bone fixation |
| Classification Names<br>and References: | Single/multiple component metallic bone fixation<br>appliance and accessories<br>Regulation Number: CFR 888.3030<br>Classification Number: 87 KTT |
| | Cerclage, fixation<br>Regulation Number: CFR 888.3010<br>Classification Number: 87 JDQ |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Pioneer System GTR (Greater Trochanter Reattachment)<br>(Pioneer Laboratories, Inc., K961267, cleared 6/27/96) |
| | Extended GTR Device (Pioneer Surgical Technology,<br>K000734, cleared 5/5/00) |

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Songer Cable System (Pioneer Laboratories, K935481, cleared 1/26/94)

| Device Description: | The Cable-Ready Greater Trochanter Reattachment Short<br>and Long (GTR) devices are used in combination with<br>1.8mm cobalt chrome alloy cerclage cables to stabilize<br>fractures of the greater trochanter or reattach the greater<br>trochanter after osteotomy in total hip replacement. The<br>GTR devices are designed with two upper prongs that loop<br>around the greater trochanter and two small fins on the<br>lower side to prevent migration or rotation.<br><br>In addition to being used with the GTR devices, the cobalt<br>chrome alloy 1.8mm cerclage cables, along with the<br>stainless steel cables, can be used alone to secure bone<br>fractures. |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Cable-Ready GTR System:<br><br>The Cable-Ready GTR System is indicated for the<br>reattachment of the greater trochanter following osteotomy<br>in total hip arthroplasty. Additionally, the device is used to<br>reattach the greater trochanter following fracture of the<br>greater trochanter, nonunion of fracture, or previous<br>osteotomy.<br><br>Cable-Ready 1.8mm Cerclage Cables:<br><br>Cable-Ready 1.8mm Cerclage Cables - The 1.8mm<br>cerclage cable can be used to secure fractures of the<br>olecranon, patella, femur, humerus, and ankle, as well as to<br>reduce and secure acromioclavicular dislocations. The<br>1.8mm cables can also be used to reattach the greater<br>trochanter after trochanteric osteotomy during total hip<br>arthroplasty. |
| Comparison to Predicate Device: | The subject devices incorporate similar or identical<br>materials, similar or identical indications for use, similar<br>or identical sizes of implants, and the same technological<br>characteristics as the predicate devices. |

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Performance Data (Nonclinical and/or Clinical):

Non-Clinical Performance and Conclusions:

- Shelf Life Accelerated aging testing conducted . shows that the sterile devices included in this submission have a shelf life of 10 years.
- Biocompatibility Biocompatibility testing of the . subject devices was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
- Performance Evaluation A construct fatigue test . for the GTR system and an engineering analysis for the 1.8mm cerclage cables demonstrate the subject devices are safe and effective and substantially equivalent to the predicate devices.

Conclusions: The data presented in this submission demonstrates that the subject devices are substantially equivalent to their respective predicate devices.

Clinical Performance and Conclusions:

Clinical data and conclusions were not needed for these devices to show substantial equivalence.