The Fortex Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion 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.

In addition, the Fortex Pedicle Screw System is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Device Description

The purpose of this 510(k) submission is to add rods made of a different material to the Fortex Pedicle Screw System. The modified system has the same intended use and fundamental scientific technology as the previously-cleared Fortex Pedicle Screw System.

Both the modified and predicate Fortex Pedicle Screw System consist of various screws, rods, and cross bar connectors that are used to build a construct to provide supplemental stabilization of spinal segments to support fusion.

The components of the predicate Fortex.Pedicle Screw System are fabricated from medical grade titanium alloy per ASTM F136. The modified system includes components fabricated from medical grade cobalt chrome alloy per ASTM F1537, in addition to the titanium components. As documented within this premarket notification, the addition of cobalt chrome alloy rods does not raise new issues of safety or effectiveness. Titanium and cobalt chrome components may be used together within the same construct. These components should never be used with stainless steel implant components.

AI/ML Overview

The provided text describes a 510(k) submission for the Fortex Pedicle Screw System, specifically focusing on the addition of rods made from a different material (cobalt chrome alloy). The submission aims to demonstrate substantial equivalence to a predicate device.

Crucially, this document does not contain information about acceptance criteria for a device performance study in the way you've outlined, nor does it detail a study that proves the device meets such criteria in terms of clinical outcomes or diagnostic accuracy.

Instead, the performance data presented is for non-clinical mechanical testing to demonstrate the structural integrity and comparability of the modified device components.

Here's a breakdown based on the information available and what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Note: This table reflects mechanical performance, not clinical or diagnostic performance criteria as typically found in studies for AI/diagnostic devices.

Acceptance Criterion (Mechanical)	Reported Device Performance (Summary)
Static Axial Compression Bending per ASTM F1717	Similar to predicate system
Dynamic Axial Compression Bending per ASTM F1717	Similar to predicate system
Static Torsion Tests per ASTM F1717	Similar to predicate system
Functioning as intended	Modified device functioned as intended
Substantial equivalence to predicate devices (mechanical properties)	Observed test results demonstrate substantial equivalence to predicate devices

Information Not Found in the Provided Text:

The following points are pertinent to studies of diagnostic or AI-driven medical devices, but are not applicable to this 510(k) submission, which focuses on a change in material for a spinal implant system. Therefore, the requested information for these points is not available in the provided text.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "test set" here refers to physical components for mechanical testing, not patient data.
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. Ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus on medical images or diagnoses.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable to mechanical testing.
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 a spinal implant, not an AI or diagnostic device designed to assist human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a spinal implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is derived from the physical properties and performance metrics defined by ASTM F1717 standards.
The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
How the ground truth for the training set was established: Not applicable.

Summary of the Study (Mechanical Testing):

The study involved non-clinical performance testing of the Fortex Pedicle Screw System. This included static and dynamic axial compression bending and static torsion tests. The tests were conducted according to ASTM F1717 standards. The performance of the modified system (with cobalt chrome alloy rods) was compared to the predicate system. The results demonstrated that the modified device functioned as intended and showed substantial equivalence in mechanical properties to the predicate devices. The purpose was to demonstrate that adding a new material (cobalt chrome alloy) for the rods does not introduce new safety or effectiveness concerns, and that its mechanical performance is comparable to an already cleared device.

Summary

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K120832

510(k) Summary

ADMINISTRATIVE INFORMATION

Manufacturer Name:

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

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

Fortex Pedicle Screw System

Pedicle Screw Spinal System

Official Contact:

David Kirschman, MD Chief Medical Officer

Initial Date Prepared:

March 16, 2012

DEVICE NAME

Trade/Proprietary Name: Common Name(s):

Classification Name(s):

Device Class: Classification(s): Product Codes(s): Orthosis, Spondylolisthesis Spinal Fixation Orthosis, Pedicle Spinal Fixation Class II $888.3070 MNH, MNI

ESTABLISHMENT REGISTRATION NUMBER

X-spine Systems, Inc. has submitted an Establishment Registration to FDA. The Establishment Registration number is 3005031160. The owner/operator number for X-spine Systems, Inc. is 9063903.

INTENDED USE

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DEVICE DESCRIPTION AND TECHNOLOGICAL CHARACTERISTICS

PERFORMANCE DATA

Non-clinical performance testing was conducted to characterize the modified Fortex Pedicle Screw System. Static and dynamic axial compression bending and static torsion tests in accordance with ASTM F1717 were performed on the modified and predicate systems, and the results compared. The modified device functioned as intended and the observed test results demonstrate substantial equivalence to the predicate devices.

EQUIVALENCE TO MARKETED PRODUCT

The modified Fortex Pedicle Screw System has the same intended use, indications, technological characteristics, and principles of operation as the predicate Fortex Pedicle Screw System, and the material change is to a type of material that has been used in other legally marketed devices within the same classification regulation for the same intended use such as the K2M, Inc. Range Spinal System (K080792). The modifications to the Fortex Pedicle Screw System do not raise new issues of safety or effectiveness. Also, mechanical testing demonstrated comparable mechanical properties to the predicate devices. Thus, the modified Fortex Pedicle Screw System is substantially equivalent to the predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, rendered in a bold, black color.

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

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

OCT 23 2012

Re: K120832

Trade/Device Name: Fortex Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: October 5, 2012 Received: October 9, 2012

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, 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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Daniel. Krone

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

Enclosure

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Fortex Pedicle Screw System

Indications for Use

510(k) Number (if known): K20832

Device Name: Fortex Pedicle Screw System

Indications for Use:

Prescription Use ਮ (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

(Divigion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

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K120832 510(k) Number_

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.