ANAX™ 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

· Spondylolisthesis (Grade 3 and 4)
· Degenerative spondylolisthesis with objective evidence of neurological impairment
· Trauma (i.e., fracture or dislocation)
· Spinal stenosis
· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
· Tumor
· Pseudoarthrosis
· Failed previous fusion

Device Description

ANAX™ 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. ANAX M 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. ANAX™ 5.5 Spinal System components are supplied nonsterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of ANAXTM 5.5 Spinal System implants.

AI/ML Overview

This document is a 510(k) premarket notification for the ANAX™ 5.5 Spinal System, seeking FDA clearance for marketing. It does not describe a study involving an AI/Machine Learning device or any clinical performance studies that would involve acceptance criteria and device performance as typically understood for software/AI.

Therefore, I cannot extract the information required concerning acceptance criteria and a study proving a device meets them, because this document pertains to a traditional medical device (pedicle screw spinal system) and its substantial equivalence to previously cleared predicate devices through bench testing, not a digital health product with AI/ML components.

The "Performance Testing" section explicitly states: "ANAX™ 5.5 Spinal System was tested in a non clinical setting (bench testing) to assess mechanical performance of this device. Static mechanical tests (axial gripping capacity test, torque gripping capacity test) were performed according to ASTM F1798. The testing verifies that performance of the ANAX™ 5.5 Spinal System is substantially equivalent to the predicate devices."

This type of testing focuses on the physical properties and mechanical strength of the hardware, not on diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with AI/ML performance. There is no mention of a test set, ground truth established by experts, multi-reader multi-case studies, or training data for an algorithm.

Summary

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

February 25, 2015

U & I Corporation Mr. Young-Geun Kim Regulatory Affairs Specialist 20, Sandan-ro 76beon-gil (Road) Uijeongbu-si, Gyeonggi-do Republic of Korea 480-859

Re: K143417

Trade/Device Name: ANAX™ 5.5 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: November 20, 2014 Received: December 18, 2014

Dear Mr. Kim:

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

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Page 2 - Mr. Young-Geun Kim

(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 (OS) 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/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/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,

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K143417

Device Name

ANAX 5.5 Spinal System

Indications for Use (Describe)

ANAX 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

· Spondylolisthesis (Grade 3 and 4)
· Degenerative spondylolisthesis with objective evidence of neurological impairment
· Trauma (i.e., fracture or dislocation)
· Spinal stenosis
· Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
· Tumor
· Pseudoarthrosis
· 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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510(k) Summary

Manufacturer:	U & I Corporation20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-doKorea, 480-859
Sponsor:	U & I Corporation20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-doKorea, 480-859
Sponsor Contact:	Young-Geun, Kim, Regulatory Affairs Specialist+82 31 852 0102 (ext.619)ygkim@youic.com
Date Prepared:	November 20, 2014
Device Name:	Trade Name: ANAX™ 5.5 Spinal System
Classification Name:	Pedicle screw spinal system, per 21 CFR 888.3070
Common Name:	Pedicle screw spinal fixation system
Product Code:	MNH, MNI
Predicate Devices:	OPTIMA™ Spinal System (K024096)Fixpine II System™ (K100765)ANAX™ 5.5 Spinal System (K132101)

Description of Device:

ANAX™ 5.5 Spinal System is manufactured by U&I corporation. ANAX™ 5.5 Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. ANAX M 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. ANAX™ 5.5 Spinal System components are supplied nonsterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of ANAXTM 5.5 Spinal System implants.

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Intended Use:

ANAX™ 5.5 Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletallymature patients as an adjunct to fusion by autogenous bone graft in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar and sacral spine:

Spondylolisthesis (Grade 3 and 4) .
. Degenerative spondylolisthesis with objective evidence of neurological impairment
Trauma (i.e., fracture or dislocation) .
Spinal stenosis .
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
Tumor .
. Pseudoarthrosis
. Failed previous fusion

Substantial Equivalence:

ANAX™ 5.5 Spinal System is substantially equivalent to OPTIMATM Spinal System (K024096), Fixpine II System™ (K100765) and ANAX™ 5.5 Spinal System (K132101) in design, material, mechanical performance, function and intended use.

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Technological Characteristics

The purpose of the submission is to add axial, domino, and lateral connectors to the spinal system. The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities;

. Indications for use
Design features
Same or similar materials
Mechanical performance

Performance Testing

ANAX™ 5.5 Spinal System was tested in a non clinical setting (bench testing) to assess mechanical performance of this device. Static mechanical tests (axial gripping capacity test, torque gripping capacity test) were performed according to ASTM F1798. The testing verifies that performance of the ANAX™ 5.5 Spinal System is substantially equivalent to the predicate devices.

Conclusion

The data and information provided in this submission support the conclusion that the ANAX™ 5.5 Spinal System is substantially equivalent to its predicate devices with respect to indications for use and technological characteristics.

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.