The MSFX 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Device Description

Mikron Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system consisting of polyaxial pedicle screws, rods, and set screws. The Mikron Spinal Fixation System will allow surgeons to build a spinal implant construction to stabilize and promote spinal fusion and it functions to build a spinal implant construct to stabilize and promote spinal fusion. The Mikron Spinal Fixation System components are supplied non-sterile, single use and fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136-11. Various sizes of these components are available.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Mikron Spinal Fixation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Standard Applied	Acceptance Criteria (Implied by equivalence)	Reported Device Performance
Determining Torsional Properties of Metallic Bone Screws	ASTM F 543	Equivalent to or better than predicate devices (4S Spinal System K063708, Optima Spinal System K031585) in torsional properties. The specific quantitative criteria are not provided but are implied to be met through comparison to the predicate's performance.	"The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices."
Flexion-Extension Test of Subassembly	ASTM F 1798-97(2008)	Equivalent to or better than predicate devices in flexion-extension stability and fatigue resistance.	"The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices."
Axial Torque Gripping Capacity Test for Subassembly	ASTM F 1798-97(2008)	Equivalent to or better than predicate devices in axial torque gripping capacity.	"The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices."
Axial Gripping Capacity Test	ASTM F 1798-97(2008)	Equivalent to or better than predicate devices in axial gripping capacity.	"The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices."
Static Compression Test for Subassembly	ASTM F 1717-10	Equivalent to or better than predicate devices in static compression strength.	"The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices."
Fatigue Test for Subassembly	ASTM F 1717-10	Equivalent to or better than predicate devices in fatigue life under cyclic loading.	"The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices."
Static Torsion Test	ASTM F 1717-10	Equivalent to or better than predicate devices in static torsional strength.	"The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices."
Single Cycle Bend Testing of Metallic Spinal Rods	ASTM F 2193	Equivalent to or better than predicate devices in resistance to single-cycle bending.	"The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than the predicate devices."

Explanation of Acceptance Criteria: The acceptance criteria for this medical device (Mikron Spinal Fixation System) are based on demonstrating substantial equivalence to existing legally marketed predicate devices (4S Spinal System K063708 and Optima Spinal System K031585). This means the device must perform "as well as or better than" the predicate devices in the described non-clinical mechanical tests. The specific quantitative values for acceptance are not explicitly stated but are determined by successful comparison to the predicate devices under the specified ASTM standards.

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

The provided text describes non-clinical performance testing (mechanical tests), not a clinical study involving human patients or data from patient test sets. Therefore:

Sample size used for the test set: Not applicable in the context of human data. For mechanical testing, the sample size would refer to the number of physical device components tested for each test. This specific number is not provided in the document.
Data provenance: Not applicable. The "data" are results from mechanical tests performed on the physical device components, not from patient populations.

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

Not applicable. This device's evaluation is based on non-clinical mechanical testing for substantial equivalence, not on interpretation of patient data by experts. Ground truth in this context would refer to objective mechanical properties rather than expert consensus on medical conditions.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of patient data requiring adjudication. The evaluation is based on direct comparison of mechanical test results against performance of predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study involves human readers interpreting cases (e.g., medical images) with and without AI assistance. This document describes a 510(k) submission for a spinal fixation system, relying on mechanical testing for substantial equivalence, not a study of AI-assisted human reading.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a physical medical device (spinal fixation system), not an algorithm or AI. Standalone performance testing typically applies to software or AI devices.

7. The Type of Ground Truth Used

The "ground truth" used is the mechanical performance and material characteristics of the legally marketed predicate devices. The Mikron Spinal Fixation System's performance is compared directly against the established performance of the 4S Spinal System (K063708) and Optima Spinal System (K031585) in rigorous laboratory mechanical tests designed to ASTM standards.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device and not an AI/machine learning algorithm, there is no "training set."

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

Not applicable. There is no training set for this type of device submission.

Summary

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K130073 Page 1 of 2

DEC 1 6 2013

510 (k) SUMMARY

1 OWNER / SUBMITTER INFORMATION:

Owner: Mikron Makina Sanayi Ticaret Ltd Sti Address: İ.O.S.B. Ağaç İşleri San. Sit. 1372. Sokak No:31 06370 Ivedik / Ankara / Turkey Phone Number: 90 312 3951700 Fax Number: Contact Person: Omar Diker / Ohltech Inc. / 410 885-9978 / omar@ohltech.com Date Prepared: 12/16/2013

2 DEVICE INFORMATION:

Common or Usual Name: Spinal Fixation System Proposed Proprietary or Trade Name: Mikron Spinal Fixation System Classification Name: 21 CFR 888.3070 Pedicle Screw Spinal System . Class Designation: Class II Product Codes : MNH, MNI

3 SUBSTANTIAL EQUIVALENCE:

Mikron Spinal Fixation System is substantially equivalent to the legally marketed in function, intended use, material and design to 4S Spinal System (K063708) and Optima Spinal System (K031585).

4 DEVICE DESCRIPTION:

5 INDICATION OF USE:

The MSFX Pedicle Screw System is intended to provide immobilization 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 (T1 to S2): severe spondylothesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylothesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

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6 STATEMENT OF TECHNICAL COMPARISON:

The summary of the technological characteristics of the Mikron Spinal Fixation System compared to the predicate devices are as follows:

6.1 Material

The Mikron Spinal Fixation System and predicate devices are fabricated of the same material; which is titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136-11.

6.2 Design

The Mikron Spinal Fixation System and predicate devices have similarly designed and sized components which are polyaxial screws, cylindrical longitudinal rods, and set screws. Also, the Mikron Spinal Fixation System and predicate devices have similar top-loading interconnection mechanism.

6.3 Function

The Mikron Spinal Fixation System and predicate devices have similar functions which are acting as a spinal implant construct to stabilize and promote spinal fusion.

6.4 Level of Attachment

Levels of fixation of the Mikron Spinal Fixation System are for the thoracic, lumbar and sacral spine. Similarly predicate devices are also intended to attach to spinal segment of thoracic, lumbar and sacral.

6.5 Intended Use

The Mikron Spinal Fixation System is indicated for the same intended uses as the predicate devices.

6.6 Sterility

The Mikron Spinal Fixation System is supplied in non-sterile and single use. Similarly the predicate devices are supplied non-sterile and single use.

7 NON-CLINICAL PERFORMANCE TESTING:

Test Name	Standard Applied
Determining Torsional Properties of Metallic Bone Screws	ASTM F 543
Flexion-Extension Test of Subassembly	ASTM F 1798-97(2008)
Axial Torque Gripping Capacity Test for Subassembly	ASTM F 1798-97(2008)
Axial Gripping Capacity Test	ASTM F 1798-97(2008)
Static Compression Test for Subassembly	ASTM F 1717-10
Fatigue Test for Subassembly	ASTM F 1717-10
Static Torsion Test	ASTM F 1717-10
Single Cycle Bend Testing of Metallic Spinal Rods	ASTM F 2193

The results of these mechanical tests demonstrate that the Mikron Spinal Fixation System is as safe, as effective, and performs as well as or better than 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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Public Health Service

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

December 16, 2013

Mikron Makina Sanayi Ticaret Ltd Sti % Ohltech Incorporated Mr. Omar Diker 80 Leicester Way Chesapeake City, Maryland 21915

Re: K130073

Trade/Device Name: Mikron Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: November 13, 2013 Received: November 15, 2013

Dear Mr. Diker:

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

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Page 2 – Mr. Omar Diker

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 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/Safetv/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on vour 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 vours.

Ronald P. Jean -S for

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

Enclosure

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Indications for Use

510(k) Number (if known): K130073

Device Name: Mikron Spinal Fixation System

Indications For Use: The MSFX 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 (T1 to S2): severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; spinal stenosis; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

× Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Zane W. Wyatt -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K130073

Page 1 of

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.