(192 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility of physical implants (cables, pins, needles). There is no mention of software, algorithms, image processing, or any terms related to AI/ML.
No.
The device is used to secure bone fractures and reduce dislocations, which are structural and mechanical interventions rather than therapeutic, as they do not treat a disease or condition in a physiological sense.
No
The device is indicated for use in securing fractures and dislocations, which are treatment procedures, not diagnostic ones. Its description and performance studies focus on mechanical integrity and biocompatibility for implantation.
No
The device description clearly states that the devices are physical implants (cables, pins, needles) made of stainless steel and titanium, used in surgical procedures. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The device is indicated for securing bone fractures in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device consists of cables, pins, needles, and leaders used for internal fixation of bone fractures. These are implanted medical devices.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (inside the body) for surgical repair.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
JDQ, HWC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Olecranon, proximal humerus, greater tuberosity humerus, medial malleolus tibial, patella, humerus, shoulder, ankle, sternum (for sternotomy surgery)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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:
Shelf Life - Accelerated aging testing conducted shows that the sterile devices included in this submission have a shelf life of 10 years.
Biocompatibility – Biocompatibility testing of the subject devices was conducted per ISO 10993-1 and 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.
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.
K941174, K143618, K150889, K935481
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
§ 888.3010 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.
0
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
1
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
2
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)
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.
| 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
| 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)
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.
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.
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."
4
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 708
Warsaw, IN 46581-0708 |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dalene Binkley, MS, RAC
Senior Specialist, Trauma Regulatory Affairs
Telephone: 574-372-4970
Fax: (574) 371-8760 |
| Date: | January 13, 2016 |
| Trade Name: | This is a bundled traditional 510(k). The two systems
bundled in this submission are: |
| | Cable-Ready® Cable Grip System: |
| | 1) Cable-Ready Pin System
2) Cable-Ready Needle System |
| Common Name: | Cerclage Cable and Bone Screw |
| Classification Names
and References: | Bone Fixation Cerclage
21 CFR 888.3010, JDQ |
| | Smooth or threaded metallic bone fixation fastener
21 CFR 888.3040, HWC |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Pioneer Laboratories Cable Pin (Pioneer Surgical
Technology, 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 Surgical
Technology, K935481, cleared 1/26/94) |
| 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. |
| Intended Use: | Cable-Ready Pin System:
The Cable-Ready Pin System is indicated for use in
olecranon fractures, patellar fractures, proximal humerus
fractures, greater tuberosity humerus fractures, and medial
|
| Comparison to Predicate Device: | The subject devices incorporate similar or identical
materials, similar or identical indications for use, similar
or identical sizes of implants, and the same technological
characteristics as the predicate devices. |
| Performance Data (Nonclinical
and/or Clinical): | Non-Clinical Performance and Conclusions:
Shelf Life - Accelerated aging testing conducted
shows that the sterile devices included in this
submission have a shelf life of 10 years. Biocompatibility – Biocompatibility testing of the
subject devices was conducted per ISO 10993-1 and |
5
6
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.