(87 days)
The Typhoon™ Facet Fixation Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from L1 to S1 inclusive.
The Typhoon™ Facet Screw Fixation System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history and radiographic studies; degenerative disease of the facets with instability; Spondylolisthesis; Spondylolysis; Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and trauma, including spinal fractures and/or dislocations.
For transfacet fixation, the Typhoon™ Facet Screw Fixation System is inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle.
The Typhoon™ Facet Fixation System is a posterior Facet spinal fixation system consisting of screws and washers, manufactured from titanium alloy (Ti6Al4V ELI; ASTM F136). The bone screws are designed to transfix the facet articular process in the spine to enhance spinal fusion and stability. The self-tapping screws are 4.5mm and 5.5mm in diameter. The 4.5mm screws are supplied in length ranging from 20mm to 60mm and the 5.5 mm screws range in length from 25mm to 60mm. Washers are available to increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screw to provide optimal bony contact over a range of screw trajectories.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the Typhoon™ Facet Screw Fixation System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Testing) | Reported Device Performance (Typhoon™ Facet Screw Fixation System) |
|---|---|
| Mechanical testing according to ASTM F2193 | Performed and demonstrated substantial equivalence to predicate devices. |
| - Static bending | Performed |
| - Dynamic bending | Performed |
| - Static torsion | Performed |
| - Axial pullout | Performed |
| Mechanical testing according to ASTM F543 | Performed and demonstrated substantial equivalence to predicate devices. |
| - Static bending | Performed |
| - Dynamic bending | Performed |
| - Static torsion | Performed |
| - Axial pullout | Performed |
| Equivalence in intended use, indications, anatomic location, and material to predicate devices. | Documentation provided and accepted for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information on a "test set" in the context of clinical data or a data-driven device evaluation. The evaluation for this device was based on mechanical testing, not clinical trials with human subjects. Therefore, the concepts of "sample size for the test set" and "data provenance" (country of origin, retrospective/prospective) are not applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the device's evaluation was based on mechanical testing according to established ASTM standards, not on expert-adjudicated clinical data.
4. Adjudication Method for the Test Set
This information is not applicable as the device's evaluation was based on mechanical testing, not clinical data requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The evaluation was based on mechanical testing and comparison to predicate devices, not on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This is a physical medical device (facet screw), not a software algorithm.
7. The Type of Ground Truth Used
For the mechanical testing, the "ground truth" was defined by the established performance requirements and methodologies outlined in the ASTM F2193 and ASTM F543 standards. Compliance with these standards indicates the device's acceptable mechanical properties for its intended use. For the overall substantial equivalence determination, the ground truth was the demonstrated performance and characteristics of the predicate devices.
8. The Sample Size for the Training Set
This information is not applicable as the evaluation was based on mechanical testing of physical implants, not a data-driven training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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SEP 2 0 2012
510(k) Summary
Preparation Date September 15, 2012
Sponsor
Choice Spine, LP 400 Erin Drive Knoxville, TN 37919 PH: (865)243-3969 Fax: (865)246-3334
Contact
Kim Finch Manager of Regulatory Affairs
Trade Name
Typhoon™ Facet Screw Fixation System
Classification and Common Name
Unclassified, Facet Screw Spinal Device System
Device Product Code
MRW
Predicates
DePuy AcroMed™ Inc. - Discovery™ Facet Screw System (K012773) Spine Frontier Inc. -Chameleon™ Fixation Screw System (K071420) X- Spine Systems, Inc. - Fixcet™ Spinal Facet Screw Fixation System (K100154)
Device Description
The Typhoon™ Facet Fixation System is a posterior Facet spinal fixation system consisting of screws and washers, manufactured from titanium alloy (Ti6Al4V ELI; ASTM F136). The bone screws are designed to transfix the facet articular process in the spine to enhance spinal fusion and stability. The self-tapping screws are 4.5mm and 5.5mm in diameter. The 4.5mm screws are supplied in length ranging from 20mm to 60mm and the 5.5 mm screws range in length from 25mm to 60mm. Washers are available to increase the load bearing area of the screw in contact with the bone. These washers are designed to angulate about the head of the bone screw to provide optimal bony contact over a range of screw trajectories.
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Intended Use
ર્દ્ર દ
The Typhoon™ Facet Screw Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from L1 to S1 inclusive.
The Facet Screw Fixation System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history and radiographic studies; degenerative disease of the facets with instability; Spondylolisthesis; Spondylolysis; Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and trauma, including spinal fractures and/or dislocations. For transfacet fixation, the Typhoon™ Facet Fixation System screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the inferior pedicle.
Materials
The Typhoon™ Facet Fixation System implants are manufactured from Titanium alloy (Ti6AI4V) per ASTM F-136. All instrument parts that come in contact with human tissue are made from either 17-4 SS per ASTM F899 or 465 SS per ASTM F899/A564.
Substantial Equivalence
Documentation was provided that demonstrate the Typhoon™ Facet Screw Fixation System to be substantially equivalent to previously cleared device systems. The substantial equivalence is based upon equivalence in intended use, indications, anatomic location, material, and performance. Mechanical testing was performed according to ASTM F2193 "Standard Specification and Test Method for Components used in the Surgical Fixation of the Spinal Skeletal System" and ASTM F543 "Standard Specifications and Test Metallic Bone Screws". Testing parameters executed were static bending, dynamic bending, static torsion, and axial pullout.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Choice Spine, LP % Ms. Kim Finch Manager, Regulatory Affairs 400 Erin Drive Knoxville, Tennessee 37919
SEP 20 2012
Re: K121850
Trade/Device Name: Typhoon™Facet Screw Fixation System Regulatory Class: Unclassified Product Code: MRW Dated: September 4, 2012 Received: September 5, 2012
Dear Ms. Finch:
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 device-related 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.
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Page 2 - Ms. Kim Finch
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 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,
Mark N. Melkerson
Director Division of Surgical, Ofthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number: K121850
Device Name: Typhoon™ Facet Screw Fixation System
Indications for Use:
The Typhoon™ Facet Fixation Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from L1 to S1 inclusive.
The Typhoon™ Facet Screw Fixation System is indicated for treatment of any or all of the following: degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by patient history and radiographic studies; degenerative disease of the facets with instability; Spondylolisthesis; Spondylolysis; Pseudoarthrosis and failed previous fusions which are symptomatic or which may cause secondary instability or deformity; and trauma, including spinal fractures and/or dislocations.
For transfacet fixation, the Typhoon™ Facet Screw Fixation System is inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Diy/sion Sign-Off) Diffision of Surgical, Orthopedic, and Restorative Devices
1121850 510(k) Number_________________________________________________________________________________________________________________________________________________________________
Choice Spine Typhoon™ Facet Screw Fixation System 510(k)121850 Al - 2(a)
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