The Xspan™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Xspan Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.

Device Description

The Xspan™ Laminoplasty Fixation System is a posterior implant system comprised of laminoplasty plates, hinge plates, and mounting screws. Various forms and sizes of these implants are available so that adaptations can be made to take into account the pathology and anatomy of an individual patient. The system components are manufactured from Titanium based alloy in accordance with ASTM F136. The single use only implants are provided sterile [gamma radiation] and should not be reused under any circumstances.

The system also includes instrumentation to aid with implantation. The instruments are supplied in a tray which is used for instrument sterilization and storage.

AI/ML Overview

The provided text is a 510(k) Summary for the Xspan™ Laminoplasty Fixation System, a medical device for spinal surgery. This document primarily focuses on establishing substantial equivalence to predicate devices based on technological characteristics and mechanical performance. It does not contain information typically found in a study demonstrating the device meets specific acceptance criteria related to a diagnostic or AI algorithm's performance.

Therefore, many of the requested categories cannot be filled as they pertain to studies evaluating the performance of AI/diagnostic devices, which is not the subject of this 510(k) summary. I will answer based on the information available in the document, and indicate "Not Applicable" or "Not Provided" where the information is not present.

Acceptance Criteria and Study Summary for Xspan™ Laminoplasty Fixation System

This device is a surgical implant, not a diagnostic or AI-driven device. The "acceptance criteria" here refer to the performance benchmarks established through mechanical testing to demonstrate equivalence to predicate devices, rather than criteria for diagnostic accuracy (e.g., sensitivity, specificity).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Mechanical Performance	Equivalent performance to predicate devices through static and dynamic 4-point bend testing (referenced ASTM F2193 and ASTM F382).	The Xspan™ Laminoplasty Fixation System demonstrated equivalent performance to the predicate systems through static and dynamic 4-point bend testing.
Biocompatibility	Conformance to ASTM F136 for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications. Material historically proven biocompatible, corrosion-resistant, and non-toxic.	Implants are made of titanium alloy conforming to ASTM F136. The material has a long history of use and proven biocompatibility, corrosion-resistance, and non-toxicity.

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

Sample Size for Test Set: Not explicitly stated as "sample size" in the context of a clinical test set. For mechanical testing, the information on the number of devices or test specimens is not provided.
Data Provenance: Not applicable in the context of clinical data. For mechanical testing, the data origin is from internal testing performed by X-spine Systems, Inc.

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

Not applicable. This device is a surgical implant, and the performance evaluations primarily involve mechanical testing and material conformance, not expert-adjudicated ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for establishing ground truth in diagnostic studies, not for mechanical performance testing of a spinal implant.

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

Not applicable. This is a medical device (spinal implant), not an AI-driven diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is a medical device, not an AI algorithm.

7. Type of Ground Truth Used

For Mechanical Testing: Engineering specifications and standardized test methods (ASTM F2193 and ASTM F382) served as the "ground truth" or benchmarks for performance. Comparison was made against established performance profiles of predicate devices.
For Biocompatibility: Material standards (ASTM F136) and historical evidence of biocompatibility for the specified titanium alloy served as the "ground truth."

8. Sample Size for the Training Set

Not applicable. This device does not involve an AI algorithm that requires a training set.

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

Not applicable. This device does not involve an AI algorithm or a training set.

Summary

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

March 15, 2016

X-spine Systems, Incorporated Kriss Anderson Director, Regulatory Affairs 452 Alexandersville Road Miamisburg, Ohio 45342

Re: K160114

Trade/Device Name: Xspan™ Laminoplasty Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: NQW Dated: January 15, 2016 Received: January 19, 2016

Dear Kriss Anderson:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Lori A. Wiggins -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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Indications for Use

510(k) Number (if known) K160114

R10011+

Device Name Xspan™ Laminoplasty Fixation System

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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510(K) SUMMARY (21 CFR 807.92)

Xspan™ Laminoplasty Fixation System January 15, 2016

l. SUBMITTER/MANUFACTURER:

X-spine Systems, Inc. 452 Alexandersville Rd. Miamisburg, OH 45342

Telephone (937) 847-8400 FAX (937) 847-8410

Establishment Registration Number: 3005031160

Mr. Kriss Anderson Official Contact: Director, Requlatory Affairs Email: kanderson@X-spine.com Telephone (937) 847-8400, ext. 137

ll. OWNER/OPERATOR:

Xtant Medical Inc. 604 Cruiser Lane Belgrade, MT 59714

Owner/Operator Number: 10028385

Official Correspondent:

Stephen Smith, Vice President Regulatory Assurance/ Quality Assurance Xtant Medical, Inc. Telephone (406) 388-0480

lll. DEVICE

Trade/Proprietary Name: Xspan™ Laminoplasty Fixation System Device Common Name: Orthosis, Spine, Plate, Laminoplasty, Metal Device Class: Class II Requlation Number: 21 CFR §888.3050 NQW - Orthosis, Spine, Plate, Laminoplasty, Product Code: Metal Orthopedic

Review Panel:

X-Spine Systems, Inc.

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IV. PREDICATE DEVICES

Aesculap Implant Systems (AIS): AIS Laminoplasty Plating System (K103284; . K090354) (Primary Predicate)
- o This predicate has not been subject to a design related recall.
NuVasive Laminoplasty Fixation System (K091623) o
- o This predicate has not been subject to a design related recall.

V. INTENDED USE

The Xspan™ Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Xspan™ Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent expulsion of the allograft or impingement of the spinal cord.

VI. DEVICE DESCRIPTION

The system also includes instrumentation to aid with implantation. The instruments are supplied in a tray which is used for instrument sterilization and storage.

VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The technological principle for both the subject and predicate devices is posterior fixation in the lower cervical and upper thoracic spine (C3 to T3), used in laminoplasty procedures. At a high level, the subject device Xspan™ Laminoplasty Fixation System and the predicate devices AIS Laminoplasty Plating System (K103284; K090354) and NuVasive Laminoplasty Fixation System (K091623) are based on the following same or equivalent technological elements:

FDA Product Code: NQW Orthosis, Spine, Plate, Laminoplasty, Metal. .
Implants use the same material: Titanium alloy. ●
Equivalent intended uses. ●
Variety of implant sizes and forms providing a range of options to accommodate variations in patient anatomy.
Same anatomical region. ●
Same surgical approach. ●
Equivalent mechanical performance. ●

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The following difference exists between the subject device and the predicate devices:

. Sterility - the Xspan™ implants are provided in sterile, single use packages. The predicate devices are provided non-sterile, and are sterilized by the user.

VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Evaluation

The implants of the Xspan™ Laminoplasty Fixation System are made of titanium allov. The titanium alloy conforms to ASTM F136 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The titanium material has a long history of use as surgical implants and has been proven to be biocompatible, corrosion-resistant, and not toxic to the biologic environment. The comprehensive history of biocompatibility of the implant materials provides a rationale basis for not specifically performing additional testing for each additional biological effect.

Mechanical Testing

Mechanical testing was performed with reference to ASTM F2193 Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System and ASTM F382 Standard Specification and Test Method for Metallic Bone Plates. Performance data is provided in support of the substantial equivalence determination. The Xspan™ Laminoplasty Fixation System demonstrated equivalent performance to the predicate systems through static and dynamic 4-point bend testing.

IX. CONCLUSION

Based on a review of the information provided, X-spine finds that the Xspan™ Laminoplasty Fixation System is substantially equivalent to the referenced predicate device systems. The Xspan™ Laminoplasty Fixation System was found to have an equivalent safety and effectiveness profile compared to the referenced predicate systems.

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.