Benefix™ Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); and/or tumor. Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use.

Device Description

Benefix™ Interspinous Fixation System is manufactured by U&I Corporation. The System consists of various barrels, plates, and set screws. All implant components are made of titanium alloy in accordance with ASTM F136. Benefix™ Interspinous Fixation System is intended to provide immobilization and stabilization of the spinous processes to support fusion. The components can be assembled in a various configurations so that adaptations can be made to take into pathology and individual patient anatomy. All implants are intended for single use only and should not be reused under any circumstances.

AI/ML Overview

This document is a 510(k) premarket notification for the Benefix™ Interspinous Fixation System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data for acceptance criteria based on diagnostic accuracy or clinical outcomes.

Therefore, many of the requested categories related to AI/algorithm performance and clinical study design are not applicable to this document. The "acceptance criteria" here refer to "performance criteria" derived from bench testing to demonstrate mechanical equivalence to predicates.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (derived from predicate device)	Reported Device Performance
(1) Static compression bending test (modified ASTM F1717)	Not explicitly stated in the document, but implicitly refers to performance comparable to or exceeding the predicate device (AXLE™ Interspinous Fusion System) in terms of resistance to static compression bending.	"The test results demonstrated that the Benefix™ Interspinous Fixation System is substantially equivalent to the predicate devices." (Implied: met or exceeded comparable performance to predicates for this test).
(2) Static torsion test (modified ASTM F1717)	Not explicitly stated, but implicitly refers to performance comparable to or exceeding the predicate device (AXLE™ Interspinous Fusion System) in terms of resistance to static torsion.	"The test results demonstrated that the Benefix™ Interspinous Fixation System is substantially equivalent to the predicate devices." (Implied: met or exceeded comparable performance to predicates for this test).
(3) Compression bending fatigue test (modified ASTM F1717)	Not explicitly stated, but implicitly refers to performance comparable to or exceeding the predicate device (AXLE™ Interspinous Fusion System) in terms of fatigue resistance under compression bending.	"The test results demonstrated that the Benefix™ Interspinous Fixation System is substantially equivalent to the predicate devices." (Implied: met or exceeded comparable performance to predicates for this test).
(4) Spike pull-off test	Not explicitly stated, but implicitly refers to performance comparable to or exceeding the predicate device (AXLE™ Interspinous Fusion System) in terms of resistance to spike pull-off forces.	"The test results demonstrated that the Benefix™ Interspinous Fixation System is substantially equivalent to the predicate devices." (Implied: met or exceeded comparable performance to predicates for this test).
(5) Locking mechanism strength test	Not explicitly stated, but implicitly refers to performance comparable to or exceeding the predicate device (AXLE™ Interspinous Fusion System) in terms of the strength of the locking mechanism.	"The test results demonstrated that the Benefix™ Interspinous Fixation System is substantially equivalent to the predicate devices." (Implied: met or exceeded comparable performance to predicates for this test).

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

Sample Size: Not explicitly stated for each test, but the tests were performed "in a non-clinical setting (bench testing)." This implies a sufficient number of devices were tested to statistically support the conclusions of substantial equivalence to the predicate.
Data Provenance: The data is from bench testing conducted by U & I Corporation. The country of origin of the data is not specified beyond the manufacturer's location in South Korea. It is prospective data for the device, as it was generated specifically for this submission.

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

Not applicable. This device is a physical implant, not an AI/algorithm. Ground truth in this context would refer to mechanical properties and performance, not expert-derived labels from medical images or clinical observations. The "ground truth" for the bench tests are the established standards and expected mechanical properties, determined through engineering principles and comparison to predicate devices.

4. Adjudication Method for the Test Set

Not applicable. As this is bench testing for mechanical properties, there is no need for human expert adjudication of results in the traditional sense. The 'adjudication' is based on whether the measured mechanical properties meet the engineering specifications and are comparable to predicate devices.

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

No. This document describes a medical device (spinal fixation system), not an AI algorithm. MRMC studies are used to assess the impact of AI on human reader performance, which is not relevant here.

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

No. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance testing is mechanical performance data measured through standardized bench tests (modified ASTM F1717, spike pull-off, locking mechanism strength). The targets for this "ground truth" are derived from the established performance characteristics and safety profiles of the legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI algorithm that requires a training set.

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

Not applicable. As there is no training set for an AI algorithm, this question is irrelevant.

Summary

{0}------------------------------------------------

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

September 3, 2015

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

Re: K143631

Trade/Device Name: Benefix™ Interspinous Fixation System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal interlaminal fixation orthosis Regulatory Class: Class II Product Code: PEK Dated: August 17, 2015 Received: August 19, 2015

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

{1}------------------------------------------------

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,

Lori A. Wiggins -S

for

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

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K143631

Device Name Benefix™ Interspinous Fixation System

Indications for Use (Describe)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{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 Specialist+82 31 860 6836ygkim@youic.com
Date Prepared:	Aug 17, 2015
Trade Name:	BenefixTM Interspinous Fixation System
Device Classification:	Class II
Classification Name:	Spinal interlaminal fixation orthosis, per 21 CFR 888.3050
Common Name:	Spinous Process Plate
Product Code:	PEK
Primary Predicate:	X-Spine Systems AXLETM Interspinous Fusion System(K130438)
Additional Predicates:	Medtronic CD Horizon SPIRETM Stabilization System(K043053)Lanx AspenTM Spinous Process System (K090252)

Description of Device:

Image /page/3/Picture/5 description: The image shows the logo for U&I Corporation. The logo features the letters "U&I" in a bold, sans-serif font, with the "I" having a red square above it. To the right of the letters, the word "CORPORATION" is written in a smaller, sans-serif font.

{4}------------------------------------------------

individual patient anatomy. All implants are intended for single use only and should not be reused under any circumstances.

Indications for Use:

Benefix™ Interspinous Fixation System is a posterior, non-pedicle supplemental fixation device, intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. Benefix™ Interspinous Fixation System is intended for use with bone graft material and is not intended for stand-alone use.

Substantial Equivalence:

Benefix™ Interspinous Fixation System is substantially equivalent to AXLE™ Interspinous Fusion System, CD Horizon SPIRE™ Stabilization System, Aspen™ Spinous Process System in design, material, mechanical performance, function and intended use.

Benefix™ Interspinous Fixation System has an extension design that is similar to AXLE ! Interspinous Fusion System. Benefix™ Interspinous Fixation System is relying on AXLE™ Interspinous Fusion, which has the same intended use as the Benefix™ Interspinous Fixation System, to support substantial equivalence with respect to technological characteristics.

1. Comparison of Technological Characteristics

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

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

Image /page/4/Picture/12 description: The image shows the logo for U&I Corporation. The logo features the letters "U&I" in a bold, sans-serif font, with the "i" having a red square above it. To the right of the letters, the word "CORPORATION" is written in a smaller, sans-serif font.

{5}------------------------------------------------

2. Performance Testing

Benefix™ Interspinous Fixation System was tested in a non-clinical setting (bench testing), and the test results demonstrated that the Benefix™ Interspinous Fixation System is substantially equivalent to the predicate devices.

The following tests were performed:

(1) Static compression bending test using a modified version of ASTM F1717
(2) Static torsion test using a modified version of ASTM F1717.
(3) Compression bending fatigue test using a modified version of ASTM F1717
(4) Spike pull-off test
(5) Locking mechanism strength test

3. Conclusion

The data and information provided in this submission support the conclusion that the Benefix™ Interspinous Fixation System is substantially equivalent to the predicate devices.

Image /page/5/Picture/10 description: The image shows the logo for U&I Corporation. The logo is black, except for a red square above the letter "i". The words "U&I" are in a stylized font, and the word "Corporation" is in a more standard font.

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.