STRUXXURE®-L and STRUXXURE®-A Plate System by Nexxt Spine LLC

The STRUXXURE®-L and STRUXXURE®-A Plate System is indicated for treatment of spine instability via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracolumbar (T1-L5) spine or via an anterior surgical approach below the bifurcation of the great vessels in the lumbar and lumbosacral (1-S1) spine. The indications for use include fracture (including dislocation and subluxation), turnor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, spondylolisthesis, pseudarthrosis and failed previous spine surgery.

The STRUXXURE®-L System may also be attached to NEXXT MATRIXX® Lateral interbody devices. The STRUXXURE®-A Plate System may also be attached to NEXXT MATRIXX® ALIF interbody devices. In these configurations the STRUXXURE®-L and STRUXXURE®-A Plate System is used to treat skeletally mature patients having DDD at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

Device Description

The STRUXXURE®-L and STRUXXURE®-A Plate System is a lumbar plate and screw system. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient. The implants are sold non-sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "STRUXXURE®-L and STRUXXURE®-A Plate System." It confirms the device's substantial equivalence to legally marketed predicate devices based on its intended use and technological characteristics. However, the document does not contain the specific information requested about acceptance criteria for device performance, nor details of a study proving those criteria are met for AI/ML-based device performance.

The document focuses on the regulatory clearance process for a traditional, non-AI/ML spinal plate system, comparing its mechanical properties and design to a predicate device. It explicitly states:

"Mechanical testing of the worst case STRUXXURE®-L and STRUXXURE®-A Plate System construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion. In addition, screw backout testing and cage-plate dissociation testing were performed. The mechanical test results demonstrate that the STRUXXURE®-L and STRUXXURE®-A Plate System performance is substantially equivalent."

This indicates that the "study" demonstrating performance is mechanical testing against an ASTM standard, rather than a clinical study evaluating diagnostic accuracy or a comparative effectiveness study involving human readers and AI.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, or details regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these types of details are not present in the provided text for an AI/ML device.

Summary

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September 17, 2020

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Nexxt Spine LLC % Karen Warden, Ph.D. President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026

Re: K202192

Trade/Device Name: STRUXXURE®-L and STRUXXURE®-A Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 4, 2020 Received: August 5, 2020

Dear Dr. Warden:

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

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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 mediation-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,

Colin O'Neill, M.B.E. Acting Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K202192

Device Name STRUXXURE®-L and STRUXXURE®-A Plate System

STROATORES L and STROATORES H Plate Systems

Indications for Use (Describe)

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)
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Section 7 - 510(k) Summary

Date:	4 August 2020
Sponsor:	Nexxt Spine, LLC
	14425 Bergen Blvd, Suite B
	Noblesville, IN 46060
	Office: 317.436.7801
	Fax: 317.245.2518
Sponsor Contact:	Andy Elsbury, President
510(k) Contact:	Karen E. Warden, PhD
	BackRoads Consulting Inc.
	PO Box 566
	Chesterland, OH 44026
	Office: 440.729.8457
Trade Name:	STRUXXURE ® -L and STRUXXURE ® -A Plate System
Common Name:	Lateral and anterior lumbar plate system
Regulatory Class:	Class II
Classification Name,Regulation, ProductCode:	Appliance, fixation, spinal intervertebral body, 888.3060, KWQ
Device Description:	The STRUXXURE ® -L and STRUXXURE ® -A Plate System is a lumbar plate
	and screw system. The implants are available in a variety of sizes to
	accommodate the individual anatomic and clinical circumstances of eachpatient. The implants are sold non-sterile.
Intended Use:	The STRUXXURE ® -L and STRUXXURE ® -A Plate System is indicated for
	treatment of spine instability via a lateral or anterolateral surgical approachabove the bifurcation of the great vessels in the thoracic and thoracolumbar(T1-L5) spine or via an anterior surgical approach below the bifurcation ofthe great vessels in the lumbar and lumbosacral (L1-S1) spine. Theindications for use include fracture (including dislocation and subluxation),tumor, degenerative disc disease (DDD, defined as back pain of discogenicorigin with degeneration of the disc confirmed by patient history andradiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis,spondylolysis, spondylolisthesis, pseudarthrosis and failed previous spinesurgery.The STRUXXURE ® -L System may also be attached to NEXXT MATRIXX ®Lateral interbody devices. The STRUXXURE ® -A Plate System may also beattached to NEXXT MATRIXX ® ALIF interbody devices. In these
	configurations the STRUXXURE ® -L and STRUXXURE ® -A Plate System isused to treat skeletally mature patients having DDD at one or twocontiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or as anadjunct to fusion in patients diagnosed with degenerative scoliosis.
Materials:	The STRUXXURE ® -L and STRUXXURE ® -A Plate System is manufacturedfrom titanium alloy as described by ASTM F136.
Primary Predicate:	CoreLink Lateral Plate System (CoreLink, LLC – K190016)
Performance Data:	Mechanical testing of the worst case STRUXXURE ® -L and STRUXXURE ® -A Plate System construct was performed according to ASTM F1717 andincluded static and dynamic compression and static torsion. In addition,screw backout testing and cage-plate dissociation testing were performed.The mechanical test results demonstrate that the STRUXXURE ® -L andSTRUXXURE ® -A Plate System performance is substantially equivalent.

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TechnologicalCharacteristics:	The STRUXXURE®-L and STRUXXURE®-A Plate System has the sametechnological characteristics as the predicate devices. These include basicdesign, material, method of stabilization and anatomic location. Thereforethe fundamental scientific technology of the STRUXXURE®-L andSTRUXXURE®-A Plate System is the same as previously cleared devices.
Conclusion:	The STRUXXURE®-L and STRUXXURE®-A Plate System possesses thesame intended use and technological characteristics as the predicatedevices. Therefore the STRUXXURE®-L and STRUXXURE®-A PlateSystem is substantially equivalent for its intended use.

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.