(92 days)
K003351, pre-1976
No
The device description and intended use focus on mechanical components for spinal stabilization and do not mention any software, algorithms, or data processing capabilities indicative of AI/ML.
Yes.
The device is intended to reduce pars defect and stabilize the spinal operative site during fusion procedures for conditions like spondylolisthesis, which points to a therapeutic purpose.
No
The "Posterior Cable Screw System" is a surgical implant designed to reduce pars defects and stabilize the spine. Its function is to provide mechanical support rather than to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it consists of screws, cables, and grommets, which are physical hardware components.
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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant system (screws, cables, grommets) used to stabilize the spine during fusion procedures. It is physically implanted into the patient's body.
- Intended Use: The intended use is to reduce pars defects and stabilize the spine during surgery, not to analyze biological samples.
The device is a surgical implant/spinal fixation system, not an IVD.
N/A
Intended Use / Indications for Use
The Posterior Cable Screw System is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures as an adjunct to a rigid posterior fixation system cleared/approved for trauma and spondylolisthesis. The system is indicated for the following: Defect of the pars interarticularis Spondylolisthesis The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between T1 and the sacrum. Cables may be used for interspinous wiring. The grommet may be used with the cable. The system is not intended to be used in conjunction with a stainless steel implant.
Product codes
JDQ
Device Description
The Posterior Cable Screw System consists of screws, cables, and grommets utilized for the correction of pars defects. A construct consists of two cable screws with locking set screws and a cable connecting the two screws. The screws are inserted into the pedicles and the cable is passed around the spinous process between the two screws. The grommet surrounds the cable at the location of the spinous process. The cable is tensioned and the set screws are tightened and fully locked per the surgical technique. The implants are manufactured from medical grade titanium alloy per ASTM F136 and cobalt chromium alloy per ASTM F90. The implants are provided sterile. The Posterior Cable Screw System utilizes Class I manual instruments to facilitate implantation of the device components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
T1 and the sacrum (spinal operative site, pedicle, pars interarticularis, spinous process)
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
Dynamic tests were provided to support that the Posterior Cable Screw System performs in a manner substantially equivalent to that of predicate systems. No new issues of safety or effectiveness were raised.
Key Metrics
Not Found
Predicate Device(s)
Pioneer Posterior Cable Screw System (K022908)
Reference Device(s)
ParsFix (K003351), Stainless Steel Wire (pre-1976)
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 features 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. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Frontier Medical Devices, Incorporated Ms. Bethany D. Byman Director of Regulatory Affairs 512 Fourth Street Gwinn, Michigan 49841
August 20, 2015
Re: K151346
Trade/Device Name: Frontier Medical Devices Posterior Cable Screw System Regulation Number: 21 CFR 888.3010 Regulation Name: Bone fixation cerclage Regulatory Class: Class II Product Code: JDQ Dated: May 15, 2015 Received: May 20, 2015
Dear Ms. Byman:
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
Page 2 - Ms. Bethany D. Byman
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) K151346
Device Name
Frontier Medical Devices Posterior Cable Screw System
Indications for Use (Describe)
The Posterior Cable Screw System is intended to reduce pars defect and to stabilize the spinal operative site during fusion procedures as an adjunct to a rigid posterior fixation system cleared/approved for trauma and spondylolisthesis. The system is indicated for the following:
· Defect of the pars interarticularis
· Spondylolisthesis
The Posterior Cable Screw System is indicated for pedicle screw attachment for these indications between 71 and the sacrum. Cables may be used for interspinous wiring. The grommet may be used with the cable. The system is not intended to be used in conjunction with a stainless steel implant.
| 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)
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3
510(k) Summary Pursuant to 21 CFR 807.92
| Sponsor: | Frontier Medical Devices, Inc.
512 Fourth Street
Gwinn, MI 49841 USA |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Bethany Byman
Ph: 906-232-1200
Fx: 906-232-1222 |
| | Prepared: July 17, 2015 |
| Name: | Posterior Cable Screw System |
| Trade name: | Frontier Medical Devices Posterior Cable Screw System |
| Common name: | Pedicle Screw and Spinal Cable System |
| Classifications: | §888.3010 Cerclage, Fixation, Metallic |
| Product Codes: | JDQ |
| Panel/ Branch: | Orthopaedic and Rehabilitation Devices Panel; Panel Code 87 |
| Primary Predicate: | Pioneer Posterior Cable Screw System (K022908) |
| Reference
Predicates: | ParsFix (K003351)
Stainless Steel Wire (pre-1976) |
| Description: | The Posterior Cable Screw System consists of screws, cables, and
grommets utilized for the correction of pars defects. A construct consists
of two cable screws with locking set screws and a cable connecting the
two screws. The screws are inserted into the pedicles and the cable is
passed around the spinous process between the two screws. The grommet
surrounds the cable at the location of the spinous process. The cable is
tensioned and the set screws are tightened and fully locked per the surgical
technique. The implants are manufactured from medical grade titanium
alloy per ASTM F136 and cobalt chromium alloy per ASTM F90. The
implants are provided sterile. The Posterior Cable Screw System utilizes
Class I manual instruments to facilitate implantation of the device
components. |
4
| Intended Use: | The Posterior Cable Screw System is intended to reduce pars defect and
to stabilize the spinal operative site during fusion procedures as an adjunct
to a rigid posterior fixation system cleared/approved for trauma and
spondylolisthesis. The system is indicated for the following:
Defect of the pars interarticularis Spondylolisthesis The Posterior Cable Screw System is indicated for pedicle screw
attachment for these indications between T1 and the sacrum. Cables may
be used for interspinous wiring. The grommet may be used with the cable.
The system is not intended to be used in conjunction with a stainless steel
implant. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pre-Clinical
Performance Data: | Dynamic tests were provided to support that the Posterior Cable Screw
System performs in a manner substantially equivalent to that of predicate
systems. No new issues of safety or effectiveness were raised. |
| Technological
Characteristics: | The Posterior Cable Screw 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 Posterior Cable
Screw 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. |