The Struxxure® System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.

Device Description

Struxxure consists of plates and screws in a variety of sizes. Plates from 1- to 5-levels are offered. Fixed and variable angle screws are available in two diameters in both self-tapping and self-drilling versions.

AI/ML Overview

This 510(k) summary describes a spinal fixation device, not an AI/ML device, and therefore the requested information fields (2-9) about AI/ML studies are not applicable. The device's substantial equivalence is based on mechanical performance testing against predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Measure)	Reported Device Performance (Struxxure® Components)
Mechanical Properties
Static Compression Bending (per ASTM F1717)	Meets criteria, demonstrating substantial equivalence to predicate devices.
Dynamic Compression Bending (per ASTM F1717)	Meets criteria, demonstrating substantial equivalence to predicate devices.
Static Torsion (per ASTM F1717)	Meets criteria, demonstrating substantial equivalence to predicate devices.
Technological Characteristics
Basic Design (plate and screw fixation system)	Same as predicates.
Material (titanium and titanium alloy)	Same as predicates (titanium Grade 4 or Ti-6Al-4V ELI as per ASTM F67 and ASTM F136).
Sizing (diameter and lengths)	Within the range of those offered in the predicate systems.
Anatomic Location	Same as predicates.
Intended Use	Same as predicates.

2. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML device. The "test set" in this context refers to the physical samples of the Struxxure® components subjected to mechanical testing. The provenance is the manufacturer (Nexxt Spine).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established by engineering standards (ASTM F1717) and direct measurement of physical properties, not expert consensus.

4. Adjudication method for the test set: Not applicable. Mechanical testing involves direct measurement and comparison to established standards, not adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used: For the mechanical performance, the ground truth is the measured physical properties (e.g., strength, stiffness, fatigue life) according to the specified ASTM F1717 standard. For the technological characteristics and intended use, the ground truth is the direct comparison to the characteristics of the predicate devices.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

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Section 8 – 510(k) Summary

Date:	8 November 2013
Sponsor:	Nexxt Spine
	14425 Bergen Blvd, Suite B
	Noblesville, IN 46060
	Office: 317.436.7801
	Fax: 317.245.2518
Contact Person:	Eric Lintula, Director of Engineering and Regulatory Affairs
Trade Names:	Struxxure®
Device Classification	Class II
Classification Name:	Appliance, fixation, spinal intervertebral body
Regulation:	888.3060
Device ProductCode:	KWQ
Submission Purpose:	This submission adds the Struxxure® components to the Blade®System of cervical solutions.
Device Description:	Struxxure consists of plates and screws in a variety of sizes.Plates from 1- to 5-levels are offered. Fixed and variable anglescrews are available in two diameters in both self-tapping and self-drilling versions.
Intended Use:	The Struxxure® System is intended for anterior screw fixation ofthe cervical spine. These implants have been designed to providestabilization as an adjunct to cervical fusion. Indications for the useof this implant system include degenerative disc disease (definedas neck pain of discogenic origin with the degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis,trauma (i.e., fractures or dislocations), spinal stenosis, deformity(i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis orfailed previous fusion.
Materials:	Struxxure plates and screws are manufactured from titanium(Grade 4) or titanium alloy (Ti-6Al-4V ELI) as described by ASTMF67 and ASTM F136, respectively.
Predicate Devices:	Blade® Anterior Cervical Plate System (K091936)'C-Tek® MaxAn™ Anterior Cervical Plate System (K080646)ABC2 Cervical Plating System (K050813)
Performance Data:	Static and dynamic compression bending and static torsion perASTM F1717 was used to characterize the mechanical propertiesof the Struxxure® components. The mechanical test resultsdemonstrate Struxxure® to be substantially equivalent to thepredicate devices.

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Technological Characteristics:

The Struxxure® components possess the same technological characteristics as the predicates. These include:

basic design (plate and screw fixation system), .
material (titanium and titanium alloy), .
sizing: sizes (diameter and lengths) are within the range of . those offered in the predicate systems, and
. anatomic location.

Therefore the fundamental scientific technology of the Struxxure® System is the same as previously cleared devices.

In comparison to the predicate devices, the Struxxure® Cervical Plates and Screws have

the same intended use (as described above), .
the same technological characteristics (as described above) .

Therefore the Struxxure® System can be found substantially equivalent to the predicate devices.

Conclusion:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three arms or extensions reaching upwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.

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

December 19, 2013

Nexxt Spine LLC Mr. Eric Lintula Director of Engineering and Regulatory Affairs 14425 Bergen Boulevard. Suite B Noblesville, Indiana 46060

Re: K133475

Trade/Device Name: Struxxure® Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: November 22, 2013 Received: November 25. 2013

Dear Mr. Lintula:

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. Iisting 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

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Page 2 - Mr. Eric Lintula

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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 vours.

Ronald P. Jean -S for

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 7 - Indications for Use Statement

510(k) Number: K133475

Device Name: Struxxure®

Indications for Use:

Prescription Use X

(Per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of

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.