(217 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility of a bone plate and cable system, with no mention of AI or ML.
Yes.
The device is indicated for use in providing fixation and/or stabilization of long bones for various fractures and nonunions, which are therapeutic actions aimed at treating a medical condition.
No
This device is a surgical implant designed to provide fixation and stabilization for bone fractures, not to diagnose medical conditions.
No
The device description clearly outlines physical components made of 316L stainless steel (bone plates and cerclage cable) and mentions the use of cortical bone screws, indicating it is a hardware-based medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Cable-Ready® Bone Plate System is a surgical implant used to physically fix and stabilize bone fractures. It is used in vivo (within the body), not in vitro (in a lab setting on samples).
- Intended Use: The intended use clearly states it's for "fixation and/or stabilization of long bones" in surgical procedures.
- Device Description: The description details a physical plate and cable system for securing bone fragments.
There is no mention of testing bodily samples or providing diagnostic information in the provided text.
N/A
Intended Use / Indications for Use
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.
Product codes
HRS, JDQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones – femur, tibia and humerus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Performance and Conclusions:
• Biocompatibility – Biocompatibility testing on the Cable-Ready Bone Plates and Cerclage Cable materials was conducted per ISO 10993-1 and Good Laboratory Practices (21 CFR § 58). All testing passed.
• Performance Evaluation – The engineering analysis establishes that the difference in length, number of screw holes and crimp mechanism between the subject devices and the predicate devices do not affect the clinical strength of the subject bone plates and cable.
Clinical Performance and Conclusions:
• Clinical data and conclusions were not needed for these devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
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 ) | 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) |
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."
3
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 708
Warsaw, IN 46581-0708 |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene T. Binkley
Senior Specialist, Trauma Regulatory Affairs
Telephone: 574-372-4970
Fax: (574) 371-8760 |
| Date: | July 7, 2015 |
| Trade Name: | Cable-Ready® Cable Grip System: Cable-Ready® Bone
Plate System |
| Common Name: | Plate, Fixation, Bone
Cerclage, Bone Fixation |
| Classification Names
and References: | Plate, Fixation, Bone:
Regulation Number: CFR 888.3030
Classification Number: 87 HRS |
| | Cerclage, Fixation:
Regulation Number: CFR 888.3010
Classification 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 Device
Description: | 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. |
| Intended Use: | 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. |
| Comparison to Predicate Device: | The Cable-Ready® Bone Plate System is similar in intended
use, materials, basic shape and performance characteristics
to the predicate devices. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
• Biocompatibility – Biocompatibility testing on the
Cable-Ready Bone Plates and Cerclage Cable materials
was conducted per ISO 10993-1 and Good Laboratory
Practices (21 CFR § 58). All testing passed.
• Performance Evaluation – The engineering analysis
establishes that the difference in length, number of screw
holes and crimp mechanism between the subject devices |
4
5
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.