The Trifore™ Cervical Plating System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Description

The Trifore™ Cervical Plating System consists of a variety of bone plates and screws. Fixation is achieved by inserting bone screws through the openings in the vertebral bodies of the cervical spine. The Trifore™ Plates include locking pins that cover the heads of the bone screws to reduce the potential for screw back-out. The locking pins come preassembled to the plate. Associated instruments are available to facilitate the implantation of the device. The Trifore™ Cervical Plating System implant components are made from titanium alloy such as described by ASTM F136.

AI/ML Overview

The provided text describes a medical device, the Trifore™ Cervical Plating System, and its substantial equivalence to predicate devices, but it does not contain the information requested in points 1 through 9 regarding acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) premarket notification for a spinal fixation device, which focuses on demonstrating substantial equivalence to already legally marketed predicate devices. The "performance data" section only mentions mechanical testing to ASTM F1717-14 standards, which are general engineering standards for spinal implant constructs, not specific clinical or diagnostic performance criteria.

Therefore, I cannot extract the requested information from the provided text.

The information I can confirm from the text is:

Device Name: Trifore™ Cervical Plating System
Regulatory Class: Class II (Product Code: KWO, although later listed as KWQ in the 510(k) summary)
Indications for Use: Anterior cervical fixation (C2-T1) for degenerative disc disease (DDD), spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Materials: Titanium alloy such as described by ASTM F136.
Predicate Devices: Transom™ Cervical Plating System (K142060), Tempus™ Cervical Plating System (K120515, K131374), CSLP System (K030866).
Performance Data Type: Non-clinical mechanical testing (Static axial compression bending, Static torsion, Dynamic axial compression bending fatigue per ASTM F1717-14).
Conclusion: The device is substantially equivalent to predicate devices based on overall technology characteristics and mechanical performance data.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

NeuroStructures, Inc. % Mr. Kenneth C. Maxwell II Regulatory and Quality Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, Colorado 80918 June 8, 2017

Re: K171112

Trade/Device Name: Trifore™ Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWO Dated: April 12, 2017 Received: April 14, 2017

Dear Mr. Maxwell:

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

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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.

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.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration		Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement on last page.
Indications for Use
510(k) Number (if known)	K171112
Device Name	Trifore™ Cervical Plating System
Indications for Use (Describe)	The Trifore™ Cervical Plating System is intended for anterior cervical fixation (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)	Page 1 of 2	PSC Publishing Services (301) 443-6740 EF

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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:

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Submitter's Name	NeuroStructures, Inc.
Submitter's Address	16 Technology Drive, Suite 165Irvine, CA 92618
Company Contact Person	Kathleen Wongkw@neurostructures.com949.370.4497
Contact Person	Kenneth C. Maxwell IIEmpirical Testing Corp.719.291.6874kmaxwell@empiricalconsulting.com
Date Summary wasPrepared	12 April 2017
Trade or Proprietary Name	Trifore™ Cervical Plating System
Common or Usual Name	Appliance, Fixation, Spinal Intervertebral Body
Classification	Class II per 21 CFR §888.3060
Product Code	KWQ
Classification Panel	Division of Orthopedic Devices

510(K) SUMMARY

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

INDICATIONS FOR USE

The indications for use for the Trifore™ Cervical Plating System are similar to that of the predicate devices listed in Table 5-1 Predicate Devices.

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TECHNOLOGICAL CHARACTERISTICS

The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are the same between the subject and predicates:

Indications for Use
Materials of manufacture ●
Principle of operation ●

Table 5-1: Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K142060	Transom™ Cervical Plating System	NeuroStructures, Inc.	Primary
K120515, K131374	Tempus™ Cervical Plating System	NeuroStructures, Inc.	Additional
K030866	CSLP System	Synthes	Additional

PERFORMANCE DATA

The Trifore™ Cervical Plating System has been tested in the following test modes:

Static axial compression bending per ASTM F1717-14 ●
. Static torsion per ASTM F1717-14
Dynamic axial compression bending fatigue per ASTM F1717-14 o

The results of this non-clinical testing show that the strength of the Trifore™ Cervical Plating System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Trifore™ Cervical Plating System is substantially equivalent to the predicate device.

Regulation Number and Section

N/A