The Rexious Spinal Fixation 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: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).

Device Description

The Rexious Spinal Fixation System is a top-loading multiple component, posterior spinal fixation system which consists fixation system which consists of pedicle screws, rods, set screws, connectors, and transverse (cross) linking mechanisms.

The Rexious Spinal Fixation System will allow surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The Rexious implant components are supplied non-sterile, single use and fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537. Various sizes of these implants are available.

AI/ML Overview

This document describes a spinal fixation system, not an AI device. As such, the typical acceptance criteria and study designs relevant to AI (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) are not applicable here.

Instead, the document details the Rexious Spinal Fixation System, a medical device subject to FDA 510(k) clearance. The "acceptance criteria" for such a device are primarily demonstrated through substantial equivalence to a predicate device, supported by performance testing and engineering analysis.

Here's an interpretation of the request in the context of this device:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Demonstrated through Substantial Equivalence and Testing)	Reported Device Performance (Summary from 510(k))
Material Properties: Conformity to ASTM standards for implant materials.	Components fabricated from titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67, F136, and F1295, and from Cobalt-Chromium-Molybdenum (CoCr) as specified in ASTM F1537.
Biocompatibility: Materials are suitable for implantation.	Implied by conformity to specified ASTM standards for implant materials, which inherently include biocompatibility considerations for long-term implantation.
Mechanical Performance (Static & Dynamic): Ability to withstand physiological loads without failure.	Static and Dynamic compression bend tests performed per ASTM F1717. The addition of new components (lengths of rods, new material for rods, additional screw sizes, and transverse connector sizes) did not introduce a new worst-case construct as evaluated based on an engineering analysis, indicating performance is maintained within acceptable limits compared to the predicate.
Design Characteristics:	Top-loading multiple component, posterior spinal fixation system consisting of pedicle screws, rods, set screws, connectors, and transverse (cross) linking mechanisms. Various sizes available. The modified system has the same fundamental scientific technology as the previously cleared system.
Intended Use: Device performs its specified function in treating spinal instabilities/deformities as an adjunct to fusion.	Intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of: degenerative disc disease, spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). This is consistent with the predicate device.
Sterilization: Supplied non-sterile, single-use.	Components are supplied non-sterile, single use. Sterilization procedures, if required prior to use, would be performed by the end-user facility as per standard medical practice and the device's IFU (not detailed here, but a general requirement for non-sterile devices).

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify a "sample size" in the context of clinical data for a "test set" as one would for an AI algorithm. Instead, it refers to the addition of components and various sizes of these implants. The testing (ASTM F1717) would have been performed on a statistically relevant number of samples of each component or construct configuration to demonstrate mechanical properties. The exact number of samples for each test (e.g., how many rods of each length, how many screws of each size) is not explicitly stated in this summary.
Data Provenance: Not applicable in the context of clinical data as no clinical study is described for this 510(k) submission. The data provenance refers to material testing and engineering analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device's clearance is based on mechanical performance testing and substantial equivalence, not on expert-adjudicated clinical "ground truth" data sets like an AI model would require.

4. Adjudication method for the test set:

Not applicable. There is no human adjudication of a "test set" in the context of this device. Mechanical tests have objective pass/fail criteria based on standards (e.g., ASTM F1717).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human reader performance is being evaluated, often with or without AI assistance. This is a spinal fixation system, not a diagnostic imaging or AI device.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used:

For a spinal fixation system, the "ground truth" for performance is typically established by:
- Material specifications: Adherence to recognized ASTM standards for implant materials (e.g., ASTM F67, F136, F1295, F1537).
- Mechanical test standards: Performance meeting the requirements of established international standards for spinal implants (e.g., ASTM F1717 for static and dynamic compression bending). These standards define the expected mechanical behavior and failure modes.
- Engineering analysis: Demonstrating that design changes (like new rod lengths or materials) do not introduce new "worst-case" scenarios or negatively impact performance compared to the predicate.

8. The sample size for the training set:

Not applicable. This is a medical device (hardware), not an AI algorithm, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable. As above, there is no "training set" for this type of device.

Summary

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December 8, 2017

Huvexel Co., Ltd. % Mr. Milan George Senior Director Dio Medical Corporation 8770 W Bryn Mawr Avenue, Suite 1250 Chicago, Illinois 60631

Re: K173131

Trade/Device Name: Rexious Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: November 9, 2017 Received: November 13, 2017

Dear Mr. George:

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 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);

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Page 2 - Mr. Milan George

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S for

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

Enclosure

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Indications for Use

510(k) Number (if known) K173131

Device Name Rexious Spinal Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K173131

Page 1 of 2

510(k) SUMMARY

HUVEXEL Co., Ltd's CoCr Rods & Additional Implants

Sponsor:	Manufacturer	HUVEXEL Co., Ltd.101-105 Megacenter, SK Technopark124 Sagimakgol-ro, Jungwon-gu Seongnam-siGyeonggi-do, South Korea
	Official Contact	Milan George
	Phone:	267-737-9496 x102
	Fax:	847-795-1079
	Date:	November 9, 2017
Device Name:	Rexious Spinal Fixation System
Common Name:	Pedicle Screw Spinal Fixation System
Classification Name:	Thoracolumbosacral Pedicle Screw System
ClassificationNumber:	21 CFR 888.3070
ProductCode/Classification:	NKB, class II
Description:	The Rexious Spinal Fixation System is a top-loading multiple component,posterior spinal fixation system which consists fixation system whichconsists of pedicle screws, rods, set screws, connectors, and transverse(cross) linking mechanisms.
	The Rexious Spinal Fixation System will allow surgeons to build a spinalimplant construct to stabilize and promote spinal fusion. The Rexiousimplant components are supplied non-sterile, single use and fabricatedfrom titanium or titanium alloy (Ti-6Al-4V ELI) as specified in ASTM F67,F136, and F1295 and from Cobalt-Chromium-Molybdenum (CoCr) asspecified in ASTM F1537. Various sizes of these implants are available.
Device Modification &TechnologicalCharacteristics:	The purpose of this 510(k) submission is to introduce additional lengths ofrods, additional material for rods, additional screw sizes, and additionaltransverse connector sizes. The modified system has the same intendeduse and fundamental scientific technology as the previously-clearedsystem.
Intended Use:	The Rexious Spinal Fixation System is intended to provideimmobilization and stabilization of spinal segments in skeletally maturepatients as an adjunct to fusion in the treatment of the following acuteand chronic instabilities or deformities of the thoracic, lumbar, andsacral spine: degenerative disc disease; spondylolisthesis; fracture;dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion(pseudarthrosis).
Performance Data:	The addition of components to the system did not introduce a new worstcase construct as evaluated based on an engineering analysis. Static andDynamic compression bend tests per ASTM F1717 were also performed.
Predicate Device:	Primary predicate: Rexious Spinal Fixation System (K111362)Additional predicate: Globus Medical Inc. - CoCr rods (K100788)
Performance and SEDetermination:	The CoCr rods and additional Rexious implants have been demonstratedto be substantially equivalent to the predicate system(s) with respect totechnical characteristics, performance, and intended use. The informationprovided within this premarket notification supports substantialequivalence of the subject device to the predicate device(s).

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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.