(217 days)
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.
The Cable-Ready® Bone Plate System is used to address complicated fractures and reconstruction of the long bones - femur, tibia and humerus. These devices are used as a compressive force to aid the surgeon in containing fracture fragments as they heal. The plate is placed on the bone and secured with a multifilament cable that is inserted into the plate and passed around the bone to the other side of the plate where it is attached and tightened, securing the fracture(s) in place. Cortical bone screws are used for additional fixation as needed.
The bone plates are offered in 3 lengths – 187mm (6 holes), 246mm (8 holes) and 305mm (10 holes). The cerclage cable is 1.8mm in diameter and 610mm in length. Both the bone plates and cable are manufactured from 316L stainless steel.
The provided document is a 510(k) summary for the Zimmer Cable-Ready® Cable Grip System: Cable-Ready® Bone Plate System. This is a medical device for bone fixation, and the summary details its substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or standalone algorithm evaluation in the way that would typically apply to software or AI devices.
Therefore, many of the requested categories (e.g., sample sizes for test/training sets, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable to this type of device submission and the information provided.
Based on the available information, here's what can be extracted:
1. Acceptance Criteria and Reported Device Performance
The concept of "acceptance criteria" and "reported device performance" are presented differently for this type of medical device which relies on demonstrating substantial equivalence to a predicate device. The "performance" here primarily refers to the device's physical and mechanical properties being comparable or superior to the predicate, ensuring it performs its intended function safely and effectively.
| Acceptance Criteria (Implied by Substantial Equivalence and Performance Testing) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993-1 and GLP standards. | All biocompatibility testing passed. |
| Mechanical Strength/Performance: Differences in length, number of screw holes, and crimp mechanism between subject and predicate devices should not affect clinical strength. | Engineering analysis establishes that these differences do not affect the clinical strength of the subject bone plates and cable. |
| Intended Use: Comparable to predicate. | Intended use is similar to predicate devices. |
| Materials: Comparable to predicate. | Materials (316L stainless steel) are similar to predicate devices. |
| Basic Shape: Comparable to predicate. | Basic shape is similar to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission relies on non-clinical performance data (biocompatibility and engineering analysis) and comparison to predicate devices, not on a test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No test set requiring expert-established ground truth was used for this submission.
4. Adjudication Method
Not applicable. No test set involving human review or adjudication was used for this submission.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done as this is a physical medical device, not a diagnostic or AI-powered imaging device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
For biocompatibility, the "ground truth" is adherence to established international standards (ISO 10993-1) and Good Laboratory Practices (GLP). For mechanical performance, the "ground truth" is robust engineering analysis and scientific principles demonstrating that design variations do not compromise clinical strength.
8. The Sample Size for the Training Set
Not applicable. No training set was used.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set was used.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping to create a sense of depth and connection. The profiles are rendered in a simple, line-art style.
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 (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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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 ) | 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| 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.P.O. Box 708Warsaw, IN 46581-0708 |
|---|---|
| Contact Person: | Dalene T. BinkleySenior Specialist, Trauma Regulatory AffairsTelephone: 574-372-4970Fax: (574) 371-8760 |
| Date: | July 7, 2015 |
| Trade Name: | Cable-Ready® Cable Grip System: Cable-Ready® BonePlate System |
| Common Name: | Plate, Fixation, BoneCerclage, Bone Fixation |
| Classification Namesand References: | Plate, Fixation, Bone:Regulation Number: CFR 888.3030Classification Number: 87 HRS |
| Cerclage, Fixation:Regulation Number: CFR 888.3010Classification Number: 87 JDQ | |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Pioneer Laboratories Bone Plate with Cerclage Cable,Pioneer Laboratories, K940729, cleared December 27,1994 |
| Pioneer Laboratories Bone Plate with Cable's Device,Pioneer Laboratories, K972223, cleared September 10,1997 | |
| Purpose and DeviceDescription: | The Cable-Ready® Bone Plate System is used to addresscomplicated fractures and reconstruction of the long bones- femur, tibia and humerus. These devices are used as acompressive force to aid the surgeon in containing fracturefragments as they heal. The plate is placed on the bone andsecured with a multifilament cable that is inserted into theplate and passed around the bone to the other side of theplate where it is attached and tightened, securing thefracture(s) in place. Cortical bone screws are used foradditional fixation as needed.The bone plates are offered in 3 lengths – 187mm (6holes), 246mm (8 holes) and 305mm (10 holes). Thecerclage cable is 1.8mm in diameter and 610mm in length.Both the bone plates and cable are manufactured from316L stainless steel. |
| Intended Use: | Cable-Ready® Bone Plate System:The Cable-Ready® Bone Plate with Cerclage Cable isindicated for use where wire, cable, or band cerclage isused in combination with bone plates to provide fixationand/or stabilization of long bones – femur, tibia andhumerus. Examples include periprosthetic fractures orbone loss, comminuted shaft fractures, and nonunions ofprevious fractures with or without failed hardware. |
| Comparison to Predicate Device: | The Cable-Ready® Bone Plate System is similar in intendeduse, materials, basic shape and performance characteristicsto the predicate devices. |
| Performance Data (Nonclinicaland/or Clinical): | Non-Clinical Performance and Conclusions:• Biocompatibility – Biocompatibility testing on theCable-Ready Bone Plates and Cerclage Cable materialswas conducted per ISO 10993-1 and Good LaboratoryPractices (21 CFR § 58). All testing passed.• Performance Evaluation – The engineering analysisestablishes that the difference in length, number of screwholes 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.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
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.(b)
Classification. Class II.