The Cable-Ready® Pin System is indicated for use in olecranon fractures, proximal humerus fractures, greater tuberosity humerus fractures, and medial malleolus tibial fractures may not be securely held by either a bone screw, bone pin, cable, or cerclage cable alone.

The Cable-Ready® Needle System is indicated for securing fractures of the olecranon, patella, humerus, shoulder and ankle, reducing and securing acromioclavicular dislocations as well as sternotomy surgery.

Device Description

Zimmer is requesting clearance for modifications to the Cable-Ready Cable Grip System: Cable-Ready Pin System and Cable-Ready Needle System. The subject devices are similar in that they are both 1.3mm cables used in reconstructive and trauma surgery, securing bone fractures. The stainless steel Cable-Ready Pin System has a partially threaded 4.0mm cancellous lag screw (pin), available in differing lengths, attached to the cable which is implanted into the bone. The Cable-Ready Needle System has a curved stainless steel surgical needle attached to either a stainless steel or titanium leader and cable that is passed through the bone. The needle is cut off once the fracture is secure. Both systems' cables utilize the same instruments to secure the crimp and trim off excess.

AI/ML Overview

The provided document is a 510(k) summary for the Zimmer Cable-Ready Cable Grip System, which consists of the Cable-Ready Pin System and the Cable-Ready Needle System. It primarily outlines the regulatory process for receiving FDA clearance based on substantial equivalence to predicate devices, rather than detailing a study focused on specific acceptance criteria and performance metrics in the way one would for a novel AI/software medical device.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them (especially those related to AI algorithm performance, ground truth, expert adjudication, MRMC studies, and training/test set details) are not applicable to this document.

However, I can extract the information relevant to the performance data presented:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a table of specific acceptance criteria with numerical targets for device performance. Instead, it describes types of non-clinical performance evaluations and their conclusions regarding safety, effectiveness, and substantial equivalence to predicate devices.

Performance Evaluation Type	Conclusion on Device Performance
Shelf Life	Accelerated aging testing shows a shelf life of 10 years.
Biocompatibility	Testing conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR 58). All testing passed.
Performance Evaluation (Cable Pin)	Static, fatigue, torque, and pullout testing demonstrate the device is safe, effective, and substantially equivalent to predicate devices.
Performance Evaluation (Cable Needle)	Engineering analyses demonstrate the device is safe, effective, and substantially equivalent to predicate devices.
Overall Conclusion	The data demonstrates that the subject devices are substantially equivalent to their respective predicate devices.

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in terms of number of devices tested for each evaluation.
Data Provenance: Not specified (e.g., country of origin). The testing was non-clinical (laboratory-based physical/mechanical testing) rather than clinical with patient data.
Retrospective/Prospective: Not applicable, as this refers to clinical data collection.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The ground truth for these non-clinical tests would be the measured physical properties or successful completion of a test standard, not an expert assessment of clinical findings.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This typically refers to resolving disagreements among human readers or experts, which is not relevant for non-clinical device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. No MRMC study was conducted, as this device is a physical implant, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

The "ground truth" for the non-clinical performance evaluation types were engineering standards, test methods, and material properties. For example, successful completion of ISO 10993-1 for biocompatibility, or meeting predefined mechanical performance benchmarks for static, fatigue, torque, and pullout testing.

8. The sample size for the training set:

Not applicable. This refers to AI algorithms.

9. How the ground truth for the training set was established:

Not applicable. This refers to AI algorithms.

Summary from the document:

The regulatory clearance for the Cable-Ready Cable Grip System was based on demonstrating substantial equivalence to existing predicate devices. This was achieved through a combination of non-clinical performance evaluations, including:

Shelf-life testing: Accelerated aging to support a 10-year shelf life.
Biocompatibility testing: Conducted according to ISO 10993-1 and 21 CFR 58 (Good Laboratory Practices). All tests passed.
Mechanical performance testing: Static, fatigue, torque, and pullout testing for the Cable-Ready Pin System.
Engineering analyses: For the Cable-Ready Needle System.

The conclusion drawn from these non-clinical studies was that the subject devices are safe, effective, and substantially equivalent to the predicate devices. The document explicitly states: "Clinical data and conclusions were not needed for these devices to show substantial equivalence."

Summary

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

January 15, 2016

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

Re: K151848

Trade/Device Name: Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II

Product Code: JDQ, HWC Dated: December 15, 2015 Received: December 17, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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Indications for Use

510(k) Number (if known)

K151848 (page 1 of 2)

Device Name

Cable-Ready® Cable Grip System: Cable-Ready® Pin System

Indications for Use (Describe)

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

510(k) Number (if known)

K151848 (page 2 or 2)

Device Name

Cable-Ready® Cable Grip System: Cable-Ready® Needle System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a stylized blue "Z" inside of a blue circle. Below the circle is the word "zimmer" in lowercase blue letters.

510(k) Summary

Sponsor:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Dalene Binkley, MS, RACSenior Specialist, Trauma Regulatory AffairsTelephone: 574-372-4970Fax: (574) 371-8760
Date:	January 13, 2016
Trade Name:	This is a bundled traditional 510(k). The two systemsbundled in this submission are:
	Cable-Ready® Cable Grip System:
	1) Cable-Ready Pin System2) Cable-Ready Needle System
Common Name:	Cerclage Cable and Bone Screw
Classification Namesand References:	Bone Fixation Cerclage21 CFR 888.3010, JDQ
	Smooth or threaded metallic bone fixation fastener21 CFR 888.3040, HWC
Classification Panel:	Orthopedics/87
Predicate Device(s):	Pioneer Laboratories Cable Pin (Pioneer SurgicalTechnology, K941174, cleared 9/19/94)
	Zimmer® Kirschner Wires and Steinmann Pins (Zimmer,Inc., K143618, cleared 2/6/15)
	Suture Wire and Wire Loops (Zimmer, Inc. K150889,cleared 7/1/15)
	Songer Cable System, Modification (Pioneer SurgicalTechnology, K935481, cleared 1/26/94)
Device Description:	Zimmer is requesting clearance for modifications to theCable-Ready Cable Grip System: Cable-Ready PinSystem and Cable-Ready Needle System. The subjectdevices are similar in that they are both 1.3mm cablesused in reconstructive and trauma surgery, securing bonefractures. The stainless steel Cable-Ready Pin System hasa partially threaded 4.0mm cancellous lag screw (pin),available in differing lengths, attached to the cable whichis implanted into the bone. The Cable-Ready NeedleSystem has a curved stainless steel surgical needleattached to either a stainless steel or titanium leader andcable that is passed through the bone. The needle is cut offonce the fracture is secure. Both systems' cables utilize thesame instruments to secure the crimp and trim off excess.
Intended Use:	Cable-Ready Pin System:The Cable-Ready Pin System is indicated for use inolecranon fractures, patellar fractures, proximal humerusfractures, greater tuberosity humerus fractures, and medial
Comparison to Predicate Device:	The subject devices incorporate similar or identicalmaterials, similar or identical indications for use, similaror identical sizes of implants, and the same technologicalcharacteristics as the predicate devices.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:Shelf Life - Accelerated aging testing conductedshows that the sterile devices included in thissubmission have a shelf life of 10 years. Biocompatibility – Biocompatibility testing of thesubject devices was conducted per ISO 10993-1 and

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Good Laboratory Practices (21 CFR 58). All testing passed.

. Performance Evaluation – A combination of performance testing - static, fatigue, torque and pullout testing for the cable pin and engineering analyses for the cable needle 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.

Regulation Number and Section

§ 888.3010 Bone fixation cerclage.

(a)
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.(b)
Classification. Class II.