(86 days)
Not Found
No
The summary describes a mechanical component for bone fixation and makes no mention of AI or ML.
No.
Explanation: The device is a temporary internal fixation component used in combination with other systems to stabilize fractures, which is a structural support function, not a therapeutic treatment.
No
The device is described as a temporary internal fixation component used in conjunction with bone plates and cerclage cables to stabilize fractures, indicating a therapeutic or surgical function rather than diagnostic.
No
The device description explicitly states the device is a "temporary internal fixation component" made of Titanium or Stainless Steel, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Cable Button is a temporary internal fixation component used within the body to stabilize bone fractures. It is a surgical implant, not a device that analyzes biological samples.
- Intended Use: The intended use clearly states it's for stabilizing fractures in long bones, which is a surgical procedure, not an in vitro diagnostic test.
- Device Description: The description details its material and how it's used in conjunction with bone plates and cables, all related to surgical fixation.
The information provided describes a surgical implant, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Cable Button is intended for use in combination with the Zimmer Locking Bone Plating Systems and Cerclage Cables, to stabilize multiple fractures or butterfly fragments in long bones.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The Cable-Ready Cable Grip System Cable Button is a temporary internal fixation component used in conjunction with Zimmer Locking Bone Plates and Cerclage Cables. The Cable Button is threaded into a vacant screw hole of Zimmer Locking Bone Plates and provides a positioning point for a Cerclage Cable. The Cable Button is available in Titanium (Ti-6AL-4V Alloy) and Stainless Steel (22-13-5 SST).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
long bones
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions: Testing and Engineering Analysis demonstrates that the proposed devices meet performance requirements.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for these devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/0 description: The image shows the logo for Zimmer Biomet. The logo consists of a circle with a stylized "Z" inside it. Below the logo, the word "zimmer" is written in lowercase letters. The image is black and white and appears to be a digital rendering.
SEP 1 1 2009
P.O. Box 708 Warsaw, IN 46581-0708 574 267-6131
KO91799
Summary of Safety and Effectiveness
Sponsor:
Contact Person:
Date:
Trade Name:
Common Name:
Classification Name and Reference:
Predicate Device:
Device Description:
Intended Use:
Comparison to Predicate Device:
Zimmer. Inc. P.O. Box 708 Warsaw, IN 46581-0708
Anthony Francalancia, RAC Senior Associate, Regulatory Affairs Telephone: (574) 372-4570 Fax: (574) 372-4605
September 9, 2009
Cable Ready® Cable Grip System Cable Button
Washer, Bolt, Nut, Orthopedic
HTN - Washer, Bolt, Nut, Orthopedic 21 CFR § 888.3030
Hex Button, manufactured by Pioneer Laboratories, K992617, cleared October 27, 1999. Cerclage Positioning Pin, manufactured by Synthes, K992891, cleared November 2, 1999.
The Cable-Ready Cable Grip System Cable Button is a temporary internal fixation component used in conjunction with Zimmer Locking Bone Plates and Cerclage Cables. The Cable Button is threaded into a vacant screw hole of Zimmer Locking Bone Plates and provides a positioning point for a Cerclage Cable. The Cable Button is available in Titanium (Ti-6AL-4V Alloy) and Stainless Steel (22-13-5 SST).
The Cable Button is intended for use in combination with the Zimmer Locking Bone Plating Systems and Cerclage Cables, to stabilize multiple fractures or butterfly fragments in long bones.
The proposed devices, like the predicates, are used in conjunction with bone plates and cerclage devices to provide a positioning point for the
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Page 2 September 9, 2009
Performance Data (Nonclinical and/or Clinical):
cerclage device. The proposed devices are made of similar materials (Stainless Steel and Titanium Alloy) as the predicates.
Non-Clinical Performance and Conclusions:
Testing and Engineering Analysis demonstrates that the proposed devices meet performance requirements.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for these devices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/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 symbol that resembles an abstract human figure or a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 1 1 2009
Zimmer, Inc. % Anthony Francalancia, RAC Senior Associate, Regulatory Affairs P.O. Box 708 Warsaw. Indiana 46581-0708
Re: K091799
Trade/Device Name: Cable Ready® Cable Grip System Cable Button Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HTN Dated: August 19, 2009 Received: August 20, 2009
Dear Mr. Francalancia:
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.
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) device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Anthony Francalancia, RAC
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), plcase go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Carbare Buehl
Mark N. Melkers Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K091799
Device Name:
Cable-Ready® Cable Grip System Cable Button
Indications for Use:
The Cable Button is intended for use in combination with the Zimmer Locking Bone Plating Systems and Cerclage Cables, to stabilize multiple fractures or butterfly fragments in long bones.
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jonita 2 for mxn
(Division Size: 262
vision of Surgical, Orthopedic, Restorative Devices
$10(k) Number K091799
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