The Fuji Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Fuji Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

Device Description

The purpose of this submission is to add the addition of a 4.5mm screw offering for the current FDA cleared Fuji Cervical plate System. It is intended for anterior fixation of the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with both self-tapping and self-drilling bone screws. The plates are available in a variety of lengths addressing multiple levels of fixation (one to four). The Fuji Cervical Plate System includes graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths, with the options of either self-tapping or self-drilling threads.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device called the "Fuji Cervical Plate System." This is a spinal implant used for spinal fusion, not an AI/Software as a Medical Device (SaMD). Therefore, the information typically contained in an acceptance criteria and study section for SaMD products (such as a table of performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance) is not applicable to this submission.

Instead, the submission focuses on demonstrating substantial equivalence to a legally marketed predicate device (Altus Spine Cervical Plate System K163061), primarily through non-clinical bench testing and engineering analysis, rather than clinical performance (e.g., diagnostic accuracy or treatment efficacy measured in human subjects).

Here's a breakdown of the relevant information provided in the document:

Device: Fuji Cervical Plate System
Type of Device: Spinal Intervertebral Body Fixation Orthosis (Implantable Hardware)
Regulatory Pathway: 510(k) Premarket Notification (demonstrates substantial equivalence to a predicate device)

Given that this is a hardware device for spinal fixation, not an image analysis or diagnostic AI, the requested information on acceptance criteria and study proving performance in the context of AI/SaMD is not present and not relevant to this specific FDA clearance.

The document implicitly states that the acceptance criteria for this type of device are typically related to:

Mechanical performance: Ensuring the device can withstand the forces it will experience in the human body (e.g., fatigue, static strength). This is assessed through non-clinical bench testing.
Biocompatibility: Ensuring the materials are safe for implantation. (Stated as Titanium Alloy that conforms to ASTM F136).
Design equivalence: Demonstrating that the new features (e.g., 4.5mm screw offering) do not introduce new safety or effectiveness concerns compared to the predicate device.

What is described in the document as evidence:

Summary of Non-Clinical Tests Submitted: "Engineering analysis was presented to demonstrate that the Fuji Cervical Plate System line extension does not present a new worst case in performance and is substantially equivalent to the predicates."
- This implies that tests such as static compression, pull-out strength, fatigue testing, or other biomechanical assessments were performed, and their results met pre-defined engineering and mechanical standards. However, the specific acceptance values or detailed results are not provided in this summary document.
Substantial Equivalence Conclusion: "The Fuji Cervical Plate System is substantially equivalent to the predicate devices in terms of intended use, material used, and performance. The device has a similar design, dimensions and instrumentation to the predicate devices."

To reiterate, the questions about AI/SaMD performance metrics and study design (e.g., MRMC, expert ground truth, training/test sets) are not applicable to the Fuji Cervical Plate System as presented in this FDA 510(k) summary.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.

May 29, 2019

Altus Partners, LLC Mr. Mark Melton Regulatory Affairs & Quality Assurance 1340 Enterprise Drive West Chester, Pennsylvania 19380

Re: K183084

Trade/Device Name: Fuji Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: October 10, 2018 Received: November 6, 2018

Dear Mr. Melton:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for CAPT Raquel Peat, PhD, MPH, USPHS Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known)

K183084

Device Name Fuji Cervical Plate System

Indications for Use (Describe)

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)

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."

{3}------------------------------------------------

510(k) Summary

SUBMITTER:	Altus Partners, LLC1340 Enterprise DriveWest Chester, PA 19380Phone: 610-355-4156Fax: 610-300-3049
CONTACT PERSON:	Mark MeltonRA&QAmmelton@altus-spine.com
DATE PREPARED:	May 29, 2019
COMMON NAME:	Cervical Plate System
PROPRIETARY NAME:	Fuji Cervical Plate System
PRIMARY PREDICATE DEVICES:	Altus Spine Cervical Plate System (K163061)
ADDITIONAL PREDICATE DEVICES:	N/A

ADDITIONAL PREDICATE DEVICES:	N/A
CLASSIFICATION NAME:	21 CFR §888.3060
PRODUCT CODES:	KWQ
DEVICE CLASS:	Class II
MATERIAL:	Titanium Alloy that conforms to ASTM F136

DEVICE DESCRIPTION:

INDICATIONS FOR USE:

{4}------------------------------------------------

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The technological characteristics of the Fuji Cervical Plate System is equivalent to the predicate device, except for the addition of the larger diameter screw.

SUMMARY OF NON-CLINAL TESTS SUBMITTED:

Engineering analysis was presented to demonstrate that the Fuji Cervical Plate System line extension does not present a new worst case in performance and is substantially equivalent to the predicates.

SUBSTANTIAL EQUIVALENCE CONCLUSION:

The Fuji Cervical Plate System is substantially equivalent to the predicate devices in terms of intended use, material used, and performance. The device has a similar design, dimensions and instrumentation to the predicate devices.

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.