The X-spine Systems, Inc. Zygafix Spinal Facet Screw System is intended for posterior fixation to the lumbar spine (L1 to S1 inclusive). The system is intended for bilateral, transfacet fixation of the facet joint in order to provide stability for fusion. The system is intended for use with only autogenous bone graft material. The system is indicated for posterior surgical treatment of any or all of the following at the L1 to S1 (inclusive) spinal levels:

. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
. Degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm,
Trauma (i.e., fractures and/or dislocations), .
Spondylolisthesis, .
Spondylolysis, ●
Pseudoarthrosis and/or failed previous fusions. .

Device Description

The X-spine Zygafix Spinal Facet Screw System is designed to provide bilateral, transfacet fixation of the spinal facet joint in the lumbar spine. The system consists of titanium alloy, cannulated bone screws that are available in various lengths and thread configurations to account for variations in patient anatomy. Each screw option contains axial fenestrations to allow the optional packing of bone graft. The screws are manufactured of medical grade Titanium alloy (Ti6Al4V) that complies with ASTM F136.

This system is not to be used with bone cement. The safety and efficacy of using bone cement with this system has not been established.

The implant components are provided clean and non-sterile. These devices are sterilized by a healthcare professional using a Steam Autoclave in accordance with the instructions for use provided by X-spine Systems Inc., as well as the instructions provided by the manufacturer of the Autoclave.

AI/ML Overview

The Zygafix™ Spinal Facet Screw System is a medical device for posterior fixation to the lumbar spine. Its acceptance criteria and performance are based on biomechanical testing and comparison to predicate devices, rather than a clinical study involving human readers or AI.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Zygafix™ Spinal Facet Screw System are based on its performance in biomechanical tests, demonstrating substantial equivalence to its predicate devices. The system was tested against various aspects of ASTM F543 and ASTM F2193 standards, designed for metallic bone screws and spinal skeletal system components, respectively. While specific numerical acceptance thresholds are not explicitly stated in the provided text, the overall acceptance criterion is that the device's performance must be "substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use."

Test Standard	Acceptance Criteria (Implicit)	Reported Device Performance
ASTM F543 – Standard Specification and Test Methods for Metallic Bone Screws	Performance comparable to predicate devices for torsional properties, driving torque, axial pullout strength, and self-tapping performance.	Biomechanical testing results indicate the Zygafix™ Spinal Facet Screw System is substantially equivalent to predicate device performance for these properties.
Annex 1 (A1) Test Method for Determining the Torsional Properties
Annex 2 (A2) Test Method for the Driving Torque
Annex 3 (A3) Test Method for Determining the Axial Pullout Strength
Annex 4 (A4) Test Method for Determining the Self-Tapping Performance
ASTM F2193 - Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System	Performance comparable to predicate devices for static and fatigue bending strength of metallic spinal screws.	Biomechanical testing results indicate the Zygafix™ Spinal Facet Screw System is substantially equivalent to predicate device performance for the static and fatigue bending strength of metallic spinal screws.
Annex 4 (A4) Test Method for Measuring the Static and Fatigue Bending Strength
Overall Equivalence to Marketed Product	Demonstration of substantial equivalence to predicate devices based on FDA Product Code, Intended Uses, Surgical Approach, Anatomical Region, Implant Materials, Product Dimensions, and Mechanical Performance.	X-spine Systems, Inc. submitted information to demonstrate substantial equivalence to the predicate devices (X-spine Systems, Inc. Fixcet Spinal Facet Screw System (K100154) and SpineFrontier, Inc. Chameleon Fixation System (K071420)) across these characteristics, including mechanical performance shown through testing.

2. Sample Size for the Test Set and Data Provenance

The provided document describes biomechanical testing of the device components, not a clinical study involving a "test set" of patients or data in the typical sense of a diagnostic or AI device. Therefore, the concept of sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) as it applies to medical imaging or diagnostics is not applicable here. The "sample" in this context refers to the number of physical devices or components subjected to the mechanical tests. The document does not specify the number of devices or components used for each biomechanical test.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the study is a biomechanical engineering study focusing on mechanical properties of an implant, not a study requiring expert interpretation or ground truth establishment in a clinical or diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable as the described study is a biomechanical engineering study and does not involve clinical data adjudication.

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

This information is not applicable. The provided document describes a premarket notification for a spinal implant, which relies on biomechanical testing for substantial equivalence, not a comparative effectiveness study involving human readers or AI assistance.

6. Standalone Performance Study

This information is not applicable. The device is an implantable medical device, not a software algorithm or diagnostic tool. Its "performance" is assessed through biomechanical testing of its physical properties.

7. Type of Ground Truth Used

The ground truth for this device is based on accepted engineering standards and physical mechanical properties. The "ground truth" for the performance of the Zygafix™ Spinal Facet Screw System is its ability to meet the performance characteristics specified in the ASTM F543 and ASTM F2193 standards, demonstrated through direct physical testing. The goal is to show it performs comparably to legally marketed predicate devices under these rigorous engineering standards.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical implant, not a machine learning model, and therefore does not involve a "training set" in the computational sense.

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

This information is not applicable for the same reasons as above; there is no "training set" for a physical medical implant.

Summary

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510(k) Summary

1 2013 MAY

ADMINISTRATIVE INFORMATION

Manufacturer Name:	X-spine Systems, Inc.452 Alexandersville Rd.Miamisburg, OH 45342
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Telephone (937) 847-8400 FAX (937) 847-8410

Official Contact:

David Kirschman, M.D. Chief Medical Officer

Date Prepared:

December 19, 2012

DEVICE NAME

Trade/Proprietary Name:	Zygafix™ Spinal Facet Screw System
Common Name:	Facet Screw
Classification Name:	System, Facet Screw Spinal Device
Product Code:	MRW
Device Class:	Unclassified

ESTABLISHMENT REGISTRATION NUMBER

The X-spine Systems, Inc. establishment registration number is 3005031160. The owner/ operator number for X-spine Systems, Inc. is 9063903.

INTENDED USE

. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
. Degenerative disease of the facets with pain and/or instability on plain flexion and extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm,

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Trauma (i.e., fractures and/or dislocations), .
Spondylolisthesis, .
Spondylolysis, ●
Pseudoarthrosis and/or failed previous fusions. .

DEVICE DESCRIPTION

This system is not to be used with bone cement. The safety and efficacy of using bone cement with this system has not been established.

EQUIVALENCE TO MARKETED PRODUCT

X-spine Systems, Inc. has submitted information to demonstrate that, for the purposes of FDA's regulation of medical devices, the Zygafix Spinal Facet Screw System is substantially equivalent to the predicate device based on a comparison including the following characteristics:

. FDA Product Code
Intended Uses ●
. Surgical Approach
. Anatomical Region
Implant Materials
. Product Dimensions
. Mechanical Performance

PREDICATE DEVICES

X-spine Systems, Inc. Fixcet Spinal Facet Screw System (K100154) .
SpineFrontier, Inc. Chameleon Fixation System (K071420) .

PERFORMANCE DATA

The implant components were tested using the following standards:

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ASTM F543 – Standard Specification and Test Methods for Metallic Bone Screws

Annex 1 (A1) Test Method for Determining the Torsional Properties of Metallic Bone . Screws
Annex 2 (A2) Test Method for the Driving Torque of Medical Bone Screws .
Annex 3 (A3) - Test Method for Determining the Axial Pullout Strength of Medical Bone Screws
Annex 4 (A4) Test Method for Determining the Self-Tapping Performance of Self-Tapping . Medical Bone Screws

ASTM F2193 - Standard Specification and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System

Annex 4 (A4) Test Method for Measuring the Static and Fatigue Bending Strength of . Metallic Spinal Screws
In conclusion, biomechanical testing results indicate that the Zygafix Spinal Facet Screw System is substantially equivalent to predicate device performance and is capable of safely and effectively performing in accordance with its intended use.

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Public Health Service

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

May 1, 2013

X-Spine Systems, Incorporated % David Kirschman. M.D. Chief Medical Officer 452 Alexandersville Road Miamisburg, Ohio 45342

Re: K123932

Trade/Device Name: Zygafix™ Spinal Facet Screw System Regulatory Class: Unclassified Product Code: MRW Dated: March 27, 2013 Received: March 28, 2013

Dear Dr. Kirschman:

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 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.

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Page 2 - David Kirschman, M.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" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Erin DKeith

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

Enclosure

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Indications for Use

510(k) Number (if known): K123932

Device Name: Zygafix™ Spinal Facet Screw System

Indications for Use:

◆ Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies),
Degenerative disease of the facets with pain and/or instability on plain flexion and . extension lateral radiographs where there is movement of the vertebral bodies relative to each other of more than 4mm,
. Trauma (i.e., fractures and/or dislocations),
. Spondylolisthesis,
. Spondylolysis,
Pseudoarthrosis and/or failed previous fusions. ●

Prescription Use	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D) X		(21 CFR 801 Subpart C)

(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: K123932

Regulation Number and Section

N/A