The 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

Device Description

The ANAX™ 5.5 Spinal System is manufactured by U&I corporation. The 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. The ANAX™ 5.5 Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The ANAX™ 5.5 Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobait-chromium-molybdenum alloy (ASTM F1537).

AI/ML Overview

The provided text describes a medical device, the ANAX™ 5.5 Spinal System, and its substantial equivalence to predicate devices, focusing on mechanical performance. This document pertains to a 510(k) submission to the FDA, which is primarily concerned with establishing substantial equivalence for medical devices based on predicate devices. It does not contain information about studies involving AI, human readers, or image-based diagnostics.

Therefore, many of the requested categories are not applicable to the provided text.

Here's a breakdown of the information that can be extracted or inferred from the provided text, and where the requested information is not present:

ANAX™ 5.5 Spinal System - Acceptance Criteria and Performance

The ANAX™ 5.5 Spinal System is a mechanical spinal fixation system designed to provide immobilization and stabilization of spinal segments. The provided document details its substantial equivalence to predicate devices based on mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance	ANAX™ 5.5 Spinal System met the acceptance criteria established from the predicate devices.
Material Composition	Fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537), similar to predicate devices.
Design Features	Similar design features to predicate devices.
Indications for Use	Similar indications for use to predicate devices.
Basic Fundamental Scientific Technology	Similar to predicate devices.

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

Sample Size for Test Set: Not explicitly stated. The testing was "bench testing" on the device itself.
Data Provenance: Not applicable in the context of clinical data/patient data. The testing was non-clinical bench testing.

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

This is not applicable. The ground truth for mechanical performance testing is based on established engineering standards (ASTM F1717) and comparison to predicate devices, not expert human interpretation for diagnostics.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on diagnostic interpretations, not for mechanical bench testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs without AI Assistance

This is not applicable. The device is a mechanical spinal fixation system, not an AI-assisted diagnostic tool or system designed to be read by human readers. Therefore, an MRMC study and AI improvement effect size is irrelevant to this submission.

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

This is not applicable. The device is a mechanical system, not an algorithm.

7. The Type of Ground Truth Used

Ground Truth: Established engineering standards (ASTM F1717 for mechanical testing) and the performance characteristics of legally marketed predicate devices.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of a mechanical device's 510(k) submission. This term applies to machine learning models.

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

This is not applicable. There is no training set for this type of device.

Summary

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K132101

Page 1 of 3

510(k) Summary

Manufacturer:	U & I Corporation20, Sandan-ro, 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,Korea, 480-859
Sponsor:	U & I Corporation20, Sandan-ro, 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,Korea, 480-859
Sponsor Contact:	Young-Geun, Kim, Regulatory Affairs Assistant+82 31 852 0102 (ext.619)ygkim@youic.com
Date Prepared:	July 5, 2013	NOV 2 5 2013
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

Description of Device:

ANAX™ 5.5 Spinal System

Page 9 of 66

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Never use stainless steel and titanium implant components in the same construct. Titanium alloy and cobalt-chromium-molybdenum alloy may be used together. Never use titanium alloy and/or cobalt-chromium-molybdenum alloy with stainless steel in the same construct.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the ANAX™ 5.5 Spinal System implants.

Intended Use:

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:

The ANAX™ 5.5 Spinal System is substantially equivalent to Synergy™ Spinal System - Synergy™ VLS Screws (K011437), Fixpine II System™ (K100765) and OPTIMA™ Spinal System (K024096) in design, material, mechanical performance, function and intended use.

ANAX™ 5.5 Spinal System

U&I CORPORATION

Page 10 of 66

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The mechanical performance of ANAX™ 5.5 Spinal System met the acceptance criteria which have been established from the predicate devices.

1. Comparison Technological Characteristics

The predicate and proposed devices have the similar intended use and basic fundamental scientific technology and share the following similarities;

The similar indications for use ●
Similar design features o
Incorporate the same or similar materials .
The equivalent mechanical performance ●

2. Performance Testing

The ANAX™ 5.5 Spinal System was tested in a non clinical setting (bench testing) to assess that to know new safety and efficiency issues were raised with this device. The testing met all acceptance criteria and verifies that performance of the ANAX™ 5.5 Spinal System is substantially equivalent to the predicate devices.

The following tests were performed:

Construct Test (ASTM F1717)

(1) Static compression bending test
(2) Static torsion test
(3) Compression bending fatigue test

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.

ANAX™ 5.5 Spinal System

Image /page/2/Picture/19 description: The image shows the logo for U&I Corporation. The logo features the letters "U&I" in a stylized font, with the word "CORPORATION" written in block letters to the right of the letters. The text is black and the background is white.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the branches of government. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public 11ealth Service

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

November 25, 2013

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

Re: K132101

Trade/Device Name: ANAXTM 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: October 24, 2013 Received: October 25, 2013

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, IDA 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

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Page 2 - Mr. Young-Geun Kim

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 331-542 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/Safety/ReportaProblem/dcfault.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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson - S

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

Enclosure

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Indications for Use. Statement

K132101

510(k) Number (if known):

Device Name: ANAXTM 5.5 Spinal System

Indications for Use:

Spondylolisthesis (Grade 3 and 4) .
Degenerative spondylolisthesis with objective evidence of neurological impairment 0
Trauma (i.e., fracture or dislocation) e
Spinal stenosis .
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) .
Tumor e
Pseudoarthrosis
Failed previous fusion

Over-The-Counter Use Prescription Use × Prescription Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132101

US&i CORPORATION

ANAX™ 5.5 Spinal System

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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.