(65 days)
Not Found
No
The device description and intended use describe a mechanical cable and crimp system for orthopedic fixation, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes.
This device is intended to treat various orthopedic fractures, which is a therapeutic use.
No
The description explicitly states the system is for "cerclage fixation of various long bone, pelvic and acetabular fractures" and "tension band fixation," indicating it is a treatment device, not a diagnostic one.
No
The device description explicitly states it consists of a "cable and crimp assembly" and "implants manufactured from medical grade stainless steel," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical device used for fixing fractures and dislocations within the body. This is an in vivo application (within a living organism).
- Device Description: The description details a cable and crimp assembly made of stainless steel for surgical implantation. This is consistent with a surgical implant, not a diagnostic test performed on samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical tool and implant used directly on the patient's anatomy.
N/A
Intended Use / Indications for Use
The In-Line Orthopedic Cable Cerclage System is intended for use in general orthopedic trauma surgery involving olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction during open reduction internal fixation (ORIF) procedures.
Product codes
JDQ
Device Description
The In-Line Orthopedic Cable Cerclage System consists of a cable and crimp assembly to allow cerclage fixation of various long bone, pelvic and acetabular fractures as well as tension band fixation of the patella, olecranon, ankle and shoulder. The implants are manufactured from medical grade stainless steel per ASTM 138. The implants are provided sterile. Instrumentation has been designed for use with this implant system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle
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)
Static and dynamic testing supports that the In-Line Orthopedic Cable Cerclage System performs in a manner substantially equivalent to that of the predicate system; no new issues of safety or effectiveness were raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K151888, K935481, K940729, K941213
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 13, 2016
Frontier Medical Devices, Inc. Allison Rogers Director of Regulatory Affairs 512 Fourth Street Gwinn, Michigan 49841
Re: K153242
Trade/Device Name: Frontier Medical Devices In-Line Orthopedic Cable Cerclage System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: November 6, 2015 Received: November 9, 2015
Dear Ms. Rogers:
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 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.
1
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) K153242
Device Name
Frontier Medical Devices In-line Orthopedic Cable Cerclage System
Indications for Use (Describe)
The In-Line Orthopedic Cable Cerclage System is intended for use in general orthopedic trauma surgery involving olecranon, patella, femur (including periprosthetic fractures), pelvic, acetabular, humeral, and ankle fractures, acromioclavicular dislocations, prophylactic banding during total joint procedures, and temporary reduction during open reduction internal fixation (ORIF) procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
In-Line Orthopedic Cable Cerclage System
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."
Traditional 510(k)
3
510(k) Summary Pursuant to 21 CFR 807.92
| Sponsor: | Frontier Medical Devices, Inc.
512 Fourth Street
Gwinn, MI 49841 USA |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Allison K. Rogers
Ph: 906-232-1200
Fx: 906-232-1222 |
| | Prepared: November 4, 2015 |
| Trade name: | Frontier Medical Devices In-Line Orthopedic Cable Cerclage System |
| Common name: | Cerclage Cable System |
| Classification: | §888.3010 Bone Fixation Cerclage |
| Product Code: | JDQ |
| Panel/ Branch: | Orthopaedic and Rehabilitation Devices Panel; Panel Code 87 |
| Predicates: | Frontier Medical Devices In-Line Orthopedic Cable Cerclage System
(K151888)
Zimmer Cable-Ready Cable Grip System (K935481 Pioneer Laboratories'
Songer Cable System, K940729 Pioneer Laboratories' Bone Plate with
Cerclage Cable, K941213 Pioneer Laboratories' Songer Cable System) |
| Description: | The In-Line Orthopedic Cable Cerclage System consists of a cable and
crimp assembly to allow cerclage fixation of various long bone, pelvic and
acetabular fractures as well as tension band fixation of the patella,
olecranon, ankle and shoulder. The implants are manufactured from
medical grade stainless steel per ASTM 138. The implants are provided
sterile. Instrumentation has been designed for use with this implant
system. |
| Indications for Use: | The In-Line Orthopedic Cable Cerclage System is intended for use in
general orthopedic trauma surgery involving olecranon, patella, femur
(including periprosthetic fractures), pelvic, acetabular, humeral, and ankle
fractures, acromioclavicular dislocations, prophylactic banding during
total joint procedures, and temporary reduction during open reduction
internal fixation (ORIF) procedures. |
| Non-Clinical
Performance Data: | Static and dynamic testing supports that the In-Line Orthopedic Cable
Cerclage System performs in a manner substantially equivalent to that of
the predicate system; no new issues of safety or effectiveness were raised. |
| Technological
Characteristics: | The In-Line Orthopedic Cable Cerclage System and predicate devices are
similar in terms of indications for use, material composition, technological
characteristics, design characteristics, and mechanical strength. The minor
differences in technological characteristics that do exist do not raise any
new types of safety or efficacy issues. |
| Substantial
Equivalence: | This submission supports the position that the subject In-Line Orthopedic
Cable Cerclage System is substantially equivalent to previously cleared
systems. There are no significant differences between the subject system
and the predicates which would adversely affect the use of the product.
Any differences were not considered significant based on mechanical
bench testing. |
4