Cable-Ready Cable Grip System: Cable-Ready Bone Plate System

K151716 · Zimmer, Inc. · HRS · Jan 28, 2016 · Orthopedic

Device Facts

• Record ID: K151716
• Device Name: Cable-Ready Cable Grip System: Cable-Ready Bone Plate System
• Applicant: Zimmer, Inc.
• Product Code: HRS · Orthopedic
• Decision Date: Jan 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cable-Ready® Bone Plate with Cerclage Cable is indicated for use where wire, cable, or band cerclage is used in combination with bone plates to provide fixation and/or stabilization of long bones femur, tibia and humerus. Examples include periprosthetic fractures or bone loss, comminuted shaft fractures, and nonunions of previous fractures with or without failed hardware.

Device Story

System comprises 316L stainless steel bone plates and multifilament cerclage cables; used for long bone fracture fixation (femur, tibia, humerus). Surgeon places plate on bone; inserts cable through plate and around bone; attaches and tightens cable to provide compressive force containing fracture fragments; cortical bone screws provide additional fixation. Used in clinical/surgical settings by orthopedic surgeons. Output is mechanical stabilization of bone fractures; aids healing by maintaining fragment alignment.

Clinical Evidence

No clinical data required. Bench testing included biocompatibility testing per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58), which passed. Engineering analysis performed to evaluate performance differences.

Technological Characteristics

Materials: 316L stainless steel. Components: Bone plates (187mm/6-hole, 246mm/8-hole, 305mm/10-hole) and 1.8mm diameter/610mm length multifilament cerclage cable. Mechanical fixation via cable-grip and cortical bone screws.

Indications for Use

Indicated for patients requiring fixation/stabilization of long bones (femur, tibia, humerus) due to periprosthetic fractures, bone loss, comminuted shaft fractures, or nonunions of previous fractures with/without failed hardware.

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 Laboratories Bone Plate with Cerclage Cable (K940729)
• Pioneer Laboratories Bone Plate with Cable's Device (K972223)

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

January 28, 2016

Zimmer, Incorporated Ms. Dalene Binklev Senior Specialist, Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

Re: K151716

Trade/Device Name: Cable-Ready® Cable Grip System: Cable-Ready® Bone Plate 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: December 23, 2015 Received: December 28, 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the

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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" (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 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**

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

| 510(k) Number ( <i>if known</i> ) | K151716 (page 1 of 1) |
|-----------------------------------|-----------------------|
|-----------------------------------|-----------------------|

| Device Name | Cable-Ready® Cable Grip System: Cable-Ready® Bone Plate System |
|-------------|----------------------------------------------------------------|
|-------------|----------------------------------------------------------------|

Indications for Use (Describe)

Cable-Ready® Bone Plate System: The Cable-Ready® Bone Plate with Cerclage Cable is indicated for use where wire, cable, or band cerclage is used in combination with bone plates to provide fixation and/or stabilization of long bones femur, tibia and humerus. Examples include periprosthetic fractures or bone loss, comminuted shaft fractures, and nonunions of previous fractures with or without failed hardware.

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

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a blue circle with a stylized letter "Z" inside. Below the circle, the word "zimmer" is written in lowercase, using a similar blue color as the "Z" in the circle above.

574 267-6131

## 510(k) Summary

| Sponsor: | Zimmer, Inc.<br>P.O. Box 708<br>Warsaw, IN 46581-0708 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley<br>Senior Specialist, Trauma Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | July 7, 2015 |
| Trade Name: | Cable-Ready® Cable Grip System: Cable-Ready® Bone<br>Plate System |
| Common Name: | Plate, Fixation, Bone<br>Cerclage, Bone Fixation |
| Classification Names<br>and References: | Plate, Fixation, Bone:<br>Regulation Number: CFR 888.3030<br>Classification Number: 87 HRS |
| | Cerclage, Fixation:<br>Regulation Number: CFR 888.3010<br>Classification Number: 87 JDQ |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Pioneer Laboratories Bone Plate with Cerclage Cable,<br>Pioneer Laboratories, K940729, cleared December 27,<br>1994 |
| | Pioneer Laboratories Bone Plate with Cable's Device,<br>Pioneer Laboratories, K972223, cleared September 10,<br>1997 |
| Purpose and Device<br>Description: | The Cable-Ready® Bone Plate System is used to address<br>complicated fractures and reconstruction of the long bones<br>- femur, tibia and humerus. These devices are used as a<br>compressive force to aid the surgeon in containing fracture<br>fragments as they heal. The plate is placed on the bone and<br>secured with a multifilament cable that is inserted into the<br>plate and passed around the bone to the other side of the<br>plate where it is attached and tightened, securing the<br>fracture(s) in place. Cortical bone screws are used for<br>additional fixation as needed.<br><br>The bone plates are offered in 3 lengths – 187mm (6<br>holes), 246mm (8 holes) and 305mm (10 holes). The<br>cerclage cable is 1.8mm in diameter and 610mm in length.<br>Both the bone plates and cable are manufactured from<br>316L stainless steel. |
| Intended Use: | Cable-Ready® Bone Plate System:<br>The Cable-Ready® Bone Plate with Cerclage Cable is<br>indicated for use where wire, cable, or band cerclage is<br>used in combination with bone plates to provide fixation<br>and/or stabilization of long bones – femur, tibia and<br>humerus. Examples include periprosthetic fractures or<br>bone loss, comminuted shaft fractures, and nonunions of<br>previous fractures with or without failed hardware. |
| Comparison to Predicate Device: | The Cable-Ready® Bone Plate System is similar in intended<br>use, materials, basic shape and performance characteristics<br>to the predicate devices. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>• Biocompatibility – Biocompatibility testing on the<br>Cable-Ready Bone Plates and Cerclage Cable materials<br>was conducted per ISO 10993-1 and Good Laboratory<br>Practices (21 CFR § 58). All testing passed.<br>• Performance Evaluation – The engineering analysis<br>establishes that the difference in length, number of screw<br>holes and crimp mechanism between the subject devices |

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and the predicate devices do not affect the clinical strength of the subject bone plates and cable.

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

Clinical Performance and Conclusions:

• Clinical data and conclusions were not needed for these devices.