The Facet FixxTM System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle. The Facet Fixx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following: Degenerative disc disease (DDD) as defined by back pain of discogenic origins confirmed by history and radiographic studies, Degenerative disease of the facets with instability, Trauma (i.e. fracture or dislocation), Spondylolisthesis, Spondylolysis, Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause secondary instability or deformity.

Device Description

The Facet FixxTM System is a posterior facet spinal fixation system consisting of screws with and without washers. The cannulated screw is offered partially or fully threaded in various diameter and length combinations.

AI/ML Overview

This device is a spinal fixation system, not an AI/ML device. Therefore, the questions related to AI/ML device performance and study design are not applicable. The provided text describes the device, its intended use, materials, and a comparison to predicate devices, focusing on mechanical performance.

Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Properties equivalent to predicate devices (Static and dynamic cantilever bending, axial pullout tests)	"The mechanical test results demonstrate the Facet FixxTM System to be substantially equivalent to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not explicitly stated as a "test set" in the context of an algorithm. For mechanical testing, the number of samples tested for static/dynamic cantilever bending and axial pullout is not specified.
Data Provenance: The mechanical testing was likely conducted in a laboratory setting, not with human patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable as this is a mechanical device, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth.

4. Adjudication Method for the Test Set:

Not applicable. Mechanical testing involves objective measurements rather than expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not an AI/ML device.

6. Standalone Performance Study:

Not applicable. This is not an AI/ML algorithm. The performance established is the mechanical performance of the device itself.

7. Type of Ground Truth Used:

Mechanical Testing Results: The "ground truth" here is the objective measurement of the device's mechanical properties (static and dynamic cantilever bending, axial pullout strength) against established ASTM standards (F2193 and F543) and comparable predicate devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that uses a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary

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Section 8 - 510(k) Summary

Date:	14 May 2013
Sponsor:	Nexxt Spine14425 Bergen Blvd, Suite BNoblesville, IN 46060Mobile: 317-224-4223Office: 317-436-7801Fax: 317 245-2518JUL 12 2013
Contact Person:	Eric Lintula, Director of Engineering
Trade Names:	Facet FixxTM
Device Classification	Unclassified
Common Name:	Facet screw spinal device
Regulation:	N/A (unclassified)
Device Product Code:	MRW
Device Description:	The Facet FixxTM System is a posterior facet spinal fixation systemconsisting of screws with and without washers. The cannulatedscrew is offered partially or fully threaded in various diameter andlength combinations.
Intended Use:	The Facet FixxTM System is intended to stabilize the spine as an aidto fusion through bilateral immobilization of the facet joints. Fortransfacet fixation, the screws are inserted through the inferiorarticular process across the facet joint and into the pedicle. Fortranslaminar facet fixation, the screws are inserted through the lateralaspect of the spinous process, through the lamina, through theinferior articular process, across the facet joint and into the pedicle.The Facet Fixx System is intended for bilateral facet fixation, with orwithout bone graft, at single or multiple levels from C2 to S1inclusive. The Facet Fixx System is indicated for treatment of any orall of the following: Degenerative disc disease (DDD) as defined byback pain of discogenic origins confirmed by history and radiographicstudies, Degenerative disease of the facets with instability, Trauma(i.e. fracture or dislocation), Spondylolisthesis, Spondylolysis,Pseudoarthrosis and failed previous fusion which are symptomatic orwhich may cause secondary instability or deformity.
Materials:	The Facet FixxTM System is manufactured from titanium alloy (Ti-6Al-4V ELI) as described by ASTM F136.
Predicate Devices:	Discovery® Facet Screw (K012773),CHAMELEONTM (K071420) and theTOWNLEY (K953076/K003928/K021705)
Performance Data:	Static and dynamic cantilever bending (ASTM F2193) and axialpullout tests (ASTM F543) were used to characterize the mechanicalproperties of the Facet FixxTM System. The mechanical test resultsdemonstrate the Facet FixxTM System to be substantially equivalentto the predicate devices.
TechnologicalCharacteristics:	The Facet Fixx™ System possesses the same technologicalcharacteristics as the predicates. These include:
	basic design (full and partial threaded screw fixation system), material (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 Facet Fixx™ System is the same as previously cleared devices.
Conclusion:	In comparison to the predicate devices, the Facet Fixx™ System has the same intended use (as described above), the same technological characteristics or different without raising safety and effectiveness issues (as described above)
	Therefore the Facet Fixx™ System can be found substantially

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equivalent to the predicate devices.

. . . . . . . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES-USA

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

July 12, 2013

Nexxt Spine, LLC % BackRoads Consulting, Incorporated Karen E. Warden, Ph.D. 8202 Sherman Road Chesterland, Ohio 44026-2141

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K131417

Trade/Device Name: Facet Fixx™ Spinal Fixation System Regulatory Class: Unclassified Product Code: MRW Dated: May 14, 2013 Received: May 16, 2013

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. 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 (OS) 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 - Karen E. Warden, Ph.D.

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/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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincercly yours,

Erin I. Keith

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: K131417

Device Name: Facet Fixx™ Spinal Fixation System

Indications for Use:

The Facet Fixx System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.

The Facet Fixx System is intended for bilateral facet fixation, with or without bone graft, at single or multiple levels from C2 to S1 inclusive. The Facet Fixx System is indicated for treatment of any or all of the following:

Degenerative disc disease (DDD) as defined by back pain of discogenic origins . confirmed by history and radiographic studies
Degenerative disease of the facets with instability ●
Trauma (i.e. fracture or dislocation) .
Spondylolisthesis .
Spondylolysis .
Pseudoarthrosis and failed previous fusion which are symptomatic or which may cause � secondary instability or deformity

og Over-the-Counter 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)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K131417

Regulation Number and Section

N/A