The X-spine Cortical Bone Screw System is intended for posterior, non-cervical pedicle fixation to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine for the following indications:

Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion
Spondylolisthesis
Trauma (i.e. fracture or dislocation)
Spinal stenosis
Deformities or curvatures (i.e. scoliosis, kyphosis)
Spinal tumor
Pseudoarthrosis, and/or
Failed previous fusion

Device Description

The X-spinesw Cortical Bone Screw System consists of pedicle screws, rods, cross connectors, and associated instruments. 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 implant components are manufactured from Ti6Al4V ELI, a titanium based alloy which complies with ASTM F136. Alternatively, rods are also offered manufactured from cobalt chromium alloy which complies with ASTM F1537. The single use only implants are provided non-sterile, and should not be reused under any circumstances.

The system does not contain software/firmware or electrical equipment.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "X-spine Cortical Bone Screw System." It seeks to demonstrate that the new device is substantially equivalent to legally marketed predicate devices, rather than establishing new acceptance criteria or proving effectiveness through a traditional clinical study.

Therefore, many of the requested points regarding acceptance criteria and performance studies are not directly applicable or available in this type of submission. This 510(k) summary focuses on equivalence to existing devices.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

This document does not present specific acceptance criteria in the typical sense of a target performance metric (e.g., sensitivity, specificity, accuracy) for a diagnostic or therapeutic AI device. Instead, it describes mechanical testing to demonstrate substantial equivalence to predicate devices. The "acceptance criteria" here are implied to be meeting or exceeding the mechanical performance of the predicate device.

Criteria/Test	Acceptance Criteria (Implied)	Reported Device Performance
ASTM F1717 – Static and dynamic axial compression bending testing	Meets or exceeds performance of predicate device	"The X-spine Cortical Bone Screw System was subjected to the following testing ... The results of these studies show that the subject device meets or exceeds the performance of the predicate device"
ASTM F1717 - Static torsion testing	Meets or exceeds performance of predicate device	"The X-spine Cortical Bone Screw System was subjected to the following testing ... The results of these studies show that the subject device meets or exceeds the performance of the predicate device"
Overall Equivalence	No new risks introduced, substantially equivalent to predicate devices based on design, intended use, material composition, technological and functional characteristics, and mechanical performance.	"does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided. The testing described is mechanical, not clinical, and typically involves a specific number of devices or components. Details on the number of samples tested are not included. Data provenance (country, retrospective/prospective) is not relevant for this type of mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a submission for a spinal implant, not an AI device or a diagnostic tool requiring expert ground truth for a test set. The "ground truth" for mechanical testing is established by standard laboratory procedures and measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a study requiring adjudication of expert opinions.

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 device or a diagnostic tool that would involve human readers or an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For mechanical testing of devices like this, the "ground truth" is typically defined by standardized physical measurements and engineering specifications, often established by ASTM standards (e.g., ASTM F1717). There is no "expert consensus" or "pathology" in the context of mechanical performance.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth for it.

Summary

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March 15, 2018

X-spine Systems, Inc. Ms. Charlene Brumbaugh Regulatory Affairs Manager 664 Cruiser Lane Belgrade, Montana 59714

Re: K180153

Trade/Device Name: X-spine Cortical Bone Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: January 18, 2018 Received: January 19, 2018

Dear Ms. Brumbaugh:

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 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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Indications for Use

510(k) Number (if known) K180153

Device Name

X-spine Cortical Bone Screw System

Indications for Use (Describe)

· Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies

· Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion

· Spondylolisthesis
· Trauma (i.e. fracture or dislocation)
· Spinal stenosis
· Deformities or curvatures (i.e. scoliosis, kyphosis)
· Spinal tumor
· Pseudoarthrosis, and/or
· Failed previous fusion

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)

X-spinesM Cortical Bone Screw System

I.	SUBMITTER/MANUFACTURER:	X-spine Systems, Inc.A Division of Xtant Medical Inc.Corporate Office664 Cruiser LaneBelgrade, MT 59714Telephone (406) 388-0480, ext. 1128
	Establishment Registration Number:	3005031160
	Official Contact for 510k:	Charlene BrumbaughRegulatory Affairs ManagerEmail: cbrumbaugh@Xtantmedical.comTelephone (937) 847-8400, ext. 2192
II.	DATE PREPARED:	March 15, 2018
III.	OWNER/OPERATOR:	Xtant Medical Inc.604 Cruiser LaneBelgrade, MT 59714
	Owner/Operator Number:	10028385
	Official Correspondent:	Stephen Smith, Vice PresidentRegulatory Assurance/ Quality AssuranceXtant Medical, Inc.Telephone (406) 388-0480, ext. 1106
IV.	DEVICE
	Trade/Proprietary Name:Device Common Name:Regulation Number:Product Code:	X-spineSM Cortical Bone Screw SystemOrthosis, Pedicle Screw Fixation21 CFR §888.3070NKB - thoracolumbosacral pedicle screw system
	Regulatory Class:Review Panel:	Class IIOrthopedic

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V. PURPOSE OF THE SUBMISSION

The purpose for this submission is to submit a new medical device for review.

VI. PREDICATE DEVICES

Primary Predicate:

X-spine Pedicle Screw System (K152132) [Fortex®] ●

Additional Predicates:

Arsenal Spinal Fixation System (K152968) [Alphatec Spine, Inc.]
. Xia 4.5 Spinal System (K050461) [Stryker Spine]

VII. INDICATIONS FOR USE

. Degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies
. Severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion
Spondylolisthesis ●
Trauma (i.e. fracture or dislocation) ●
Spinal stenosis
Deformities or curvatures (i.e. scoliosis, kyphosis)
. Spinal tumor
. Pseudoarthrosis, and/or
Failed previous fusion

VIII. DEVICE DESCRIPTION

The system does not contain software/firmware or electrical equipment.

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IX. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The technological principle for both the subject and predicate devices is temporary posterior, non-cervical pedicle spinal fixation in order to provide immobilization and stabilization of spinal segments in skeletally mature patients, as an adjunct to spinal fixation.

As was established in this submission, the subject device, X-spine™ Cortical Bone Screw System, is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same or similar technological and functional characteristics as its primary predicate device and additional predicate devices, through comparison in areas including design, intended use, material composition, and technological and functional characteristics.

FDA Product Code: NKB
Implants use the same materials: titanium alloy and/or cobalt chrome alloy.
Multiple lengths of pedicle screws and rods to account for variations in patient anatomy.
Equivalent Intended Uses.
Same anatomical region.
Same surgical approach.
Mechanical Performance.

PERFORMANCE DATA X.

To aid in determining mechanical basis for substantial equivalence the X-spine Cortical Bone Screw System was subjected to the following testing per FDA guidance and recommendations:

. ASTM F1717 – Static and dynamic axial compression bending testing
ASTM F1717 - Static torsion testing

The results of these studies show that the subject device meets or exceeds the performance of the predicate device and does not introduce any new risks; therefore, the system is substantially equivalent to the predicate devices.

XI. CONCLUSION

Based on assessment of the indications for use, technological characteristics, performance data, and comparison to the primary predicate device and additional predicate devices, the subject device, X-spine… Cortical Bone Screw System has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.