(170 days)
Not Found
No
The device description and performance studies focus on mechanical properties and biocompatibility of a physical implant and cables, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for reattachment and stabilization of bone fractures, which are therapeutic interventions.
No
The device description and intended use clearly state that the Cable-Ready® GTR System and 1.8mm Cerclage Cables are used for reattachment and securing of bone fractures, which are therapeutic and fixation procedures, not diagnostic ones.
No
The device description clearly outlines physical components (GTR devices, cerclage cables) made of materials like cobalt chrome alloy and stainless steel, which are hardware. The performance studies also focus on hardware characteristics like shelf life, biocompatibility, and fatigue testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use clearly describes the device as being used for the reattachment of the greater trochanter and securing bone fractures. These are surgical procedures performed directly on the patient's body.
- Device Description: The description details a physical implant (GTR devices and cerclage cables) designed to be surgically placed within the body to stabilize bone.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided information does not mention any testing of biological samples.
The device described is a surgical implant used for orthopedic procedures, not a diagnostic test performed on in vitro samples.
N/A
Intended Use / Indications for Use
Cable-Ready® GTR System - The Cable-Ready® GTR System is indicated for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally; the device is used to reattach the greater trochanter following fracture of the greater trochanter, nonunion of fracture, or previous osteotomy.
Cable-Ready® 1.8mm Cerclage Cables - The 1.8mm cerclage cable can be used to secure fractures of the olecranon, patella, femur, humerus, and ankle, as well as to reduce and secure acromioclavicular dislocations. The 1.8mm cables can also be used to reattach the greater trochanteric osteotomy during total hip arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
KTT, JDQ
Device Description
The Cable-Ready Greater Trochanter Reattachment Short and Long (GTR) devices are used in combination with 1.8mm cobalt chrome alloy cerclage cables to stabilize fractures of the greater trochanter or reattach the greater trochanter after osteotomy in total hip replacement. The GTR devices are designed with two upper prongs that loop around the greater trochanter and two small fins on the lower side to prevent migration or rotation.
In addition to being used with the GTR devices, the cobalt chrome alloy 1.8mm cerclage cables, along with the stainless steel cables, can be used alone to secure bone fractures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Greater trochanter, olecranon, patella, femur, humerus, ankle, acromioclavicular
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:
- 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 construct fatigue test . for the GTR system and an engineering analysis for the 1.8mm cerclage cables 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.
Pioneer System GTR (Greater Trochanter Reattachment) (Pioneer Laboratories, Inc., K961267, cleared 6/27/96), Extended GTR Device (Pioneer Surgical Technology, K000734, cleared 5/5/00), Songer Cable System (Pioneer Laboratories, K935481, cleared 1/26/94)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 30, 2015
Zimmer, Incorporated Ms. Dalene Binkley Senior Specialist. Trauma Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46580
Re: K151907
Trade/Device Name: Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: KTT, JDQ Dated: December 14, 2015 Received: December 15, 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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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), 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" (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 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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K151907 Page 1 of 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)
Device Name
Cable-Ready® Cable Grip System: Cable-Ready® GTR System
Indications for Use (Describe)
Cable-Ready® GTR System - The Cable-Ready® GTR System is indicated for the reattachment of the greater trochanter following osteotomy in total hip arthroplasty. Additionally; the device is used to reattach the greater trochanter following fracture of the greater trochanter, nonunion of fracture, or previous osteotomy.
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.
3
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)
Device Name
Cable-Ready® Cable Grip System: Cable-Ready®1.8mm Cerclage Cables
Indications for Use (Describe)
Cable-Ready® 1.8mm Cerclage Cables - The 1.8mm cerclage cable can be used to secure fractures of the olecranon, patella, femur, humerus, and ankle, as well as to reduce and secure acromioclavicular dislocations. The 1.8mm cables can also be used to reattach the greater trochanteric osteotomy during total hip arthroplasty.
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.
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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) 372-4605 |
| Date: | July 10, 2015 |
| 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 GTR System
2) Cable-Ready 1.8mm Cerclage Cables |
| Common Name: | Single/multiple component metallic bone fixation
appliance and accessories and cerclage, bone fixation |
| Classification Names
and References: | Single/multiple component metallic bone fixation
appliance and accessories
Regulation Number: CFR 888.3030
Classification Number: 87 KTT |
| | Cerclage, fixation
Regulation Number: CFR 888.3010
Classification Number: 87 JDQ |
| Classification Panel: | Orthopedics/87 |
| Predicate Device(s): | Pioneer System GTR (Greater Trochanter Reattachment)
(Pioneer Laboratories, Inc., K961267, cleared 6/27/96) |
| | Extended GTR Device (Pioneer Surgical Technology,
K000734, cleared 5/5/00) |
5
Songer Cable System (Pioneer Laboratories, K935481, cleared 1/26/94)
| Device Description: | The Cable-Ready Greater Trochanter Reattachment Short
and Long (GTR) devices are used in combination with
1.8mm cobalt chrome alloy cerclage cables to stabilize
fractures of the greater trochanter or reattach the greater
trochanter after osteotomy in total hip replacement. The
GTR devices are designed with two upper prongs that loop
around the greater trochanter and two small fins on the
lower side to prevent migration or rotation.
In addition to being used with the GTR devices, the cobalt
chrome alloy 1.8mm cerclage cables, along with the
stainless steel cables, can be used alone to secure bone
fractures. |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Cable-Ready GTR System:
The Cable-Ready GTR System is indicated for the
reattachment of the greater trochanter following osteotomy
in total hip arthroplasty. Additionally, the device is used to
reattach the greater trochanter following fracture of the
greater trochanter, nonunion of fracture, or previous
osteotomy.
Cable-Ready 1.8mm Cerclage Cables:
Cable-Ready 1.8mm Cerclage Cables - The 1.8mm
cerclage cable can be used to secure fractures of the
olecranon, patella, femur, humerus, and ankle, as well as to
reduce and secure acromioclavicular dislocations. The
1.8mm cables can also be used to reattach the greater
trochanter after trochanteric osteotomy during total hip
arthroplasty. |
| 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. |
6
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 Good Laboratory Practices (21 CFR 58). All testing passed.
- Performance Evaluation A construct fatigue test . for the GTR system and an engineering analysis for the 1.8mm cerclage cables 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.