The INNOVERSE 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:

Severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra
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 INNOVERSE Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of variety pedicle screws, rods, set screws, connectors and cross link. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. Pedicle Screw is provided in Modular type (Tulip is provided in a separated state and assembled after screw insertion.) and pre-assembly type (Tulips are supplied assembled.). All pedicle screws have self-tapping function in INNOVERSE Spinal System. The tulip accommodates a 5.5 and 6.0 mm diameter rod in Ti Alloy and CoCr for increased construct rigidity. The INNOVERSE Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The INNOVERSE Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537).

AI/ML Overview

The provided document is a 510(k) premarket notification summary for the INNOVERSE Spinal System. The device is a posterior, noncervical pedicle fixation system and is categorized as a Class II medical device. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing clinical trial data for AI performance. Therefore, many of the requested criteria related to AI device evaluation (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this particular document.

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

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

Acceptance Criteria (Performance Testing)	Reported Device Performance
Static compression bending (according to ASTM F1717)	"demonstrate that the performance of the INNOVERSE Spinal System is substantially equivalent to the predicate device."
Static torsion (according to ASTM F1717)	"substantially equivalent to the predicate device."
Compression bending fatigue (according to ASTM F1717)	"substantially equivalent to the predicate device."
Axial gripping capacity (according to ASTM F1798)	"substantially equivalent to the predicate device."
Axial torque gripping capacity (according to ASTM F1798)	"substantially equivalent to the predicate device."

Note: The document states that the new device's performance is "substantially equivalent" to that of the predicate device for each test. Specific numerical thresholds or detailed results for individual tests are not provided in this summary but would be present in the full 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable as this submission is for a mechanical spinal system, not an AI/software device that would typically use data sets for performance evaluation in the way described. The "tests" here refer to mechanical engineering tests of the device itself.

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

This information is not applicable for the same reasons as above. Ground truth, in the context of this device, would relate to the physical properties and performance of the hardware, which are evaluated through standardized mechanical testing methods, not expert consensus on data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable as this submission is for a mechanical spinal system, not an AI/software device. Mechanical tests follow predefined protocols (e.g., ASTM standards) rather than requiring expert adjudication of results in the way clinical data might.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This is a submission for a spinal implant system, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.

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

This information is not applicable as this submission is for a mechanical spinal system, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For this mechanical device, the "ground truth" or reference for evaluating its performance comes from established ASTM standards (ASTM F1717, ASTM F1798) and comparison to the predicate device's previously cleared performance.

8. The sample size for the training set

This information is not applicable as this submission is for a mechanical spinal system, not an AI/software device that requires a training set.

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

This information is not applicable for the reasons stated above.

Summary

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February 6, 2024

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Innosys Co., Ltd. Hye-Kyung Lee Regulatory Affairs Specialist 20, Sandan-ro 76beon-gil(Rd) Uijeongbu-si, Gyeonggi-do 11781 Korea. South

Re: K233960

Trade/Device Name: INNOVERSE Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: December 15, 2023 Received: December 15, 2023

Dear Hye-Kyung Lee:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K233960

Device Name INNOVERSE Spinal System

Indications for Use (Describe)

· Severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra
· 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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

Manufacturer:	Innosys Co., Ltd.20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,Korea, 11781
Sponsor:	Innosys Co., Ltd.20, Sandan-ro 76beon-gil(Rd), Uijeongbu-si, Gyeonggi-do,Korea, 11781
Sponsor Contact:	Hye-Kyung Lee, Regulatory Affairs Specialist+82 31-860-6839hklee@inno-sys.net
Date Prepared:	December 15, 2023
Device Name:	Trade Name: INNOVERSE Spinal System
Classification Name:	Thoracolumbosacral Pedicle Screw System,per 21 CFR 888.3070
Common Name:	Thoracolumbosacral Pedicle Screw System
Product Code:	NKB

Description of Device:

The INNOVERSE Spinal System is manufactured by Innosys Co., Ltd. The INNOVERSE Spinal System is a top-loading multiple component, posterior spinal fixation system and minimally invasive surgery system which consist of variety pedicle screws, rods, set screws, connectors and cross link. Implant components are available in a variety sizes and can be rigidly locked into a variety of different configurations to suit the individual pathology and anatomical conditions of the patient. Pedicle Screw is provided in Modular type (Tulip is provided in a separated state and assembled after screw insertion.) and pre-assembly type (Tulips are supplied assembled.). All pedicle screws have self-tapping function in INNOVERSE Spinal System. The tulip accommodates a 5.5 and 6.0 mm diameter rod in Ti Alloy and CoCr for increased construct rigidity.

Image /page/3/Picture/6 description: The image shows the logo for "innosys". The word "innosys" is written in a sans-serif font, with the "inno" portion in blue and the "sys" portion in orange. There is a blue circle above the "i" in "inno".

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The INNOVERSE Spinal System allows surgeons to build a spinal implant construct to stabilize and promote spinal fusion. The INNOVERSE Spinal System components are supplied non-sterile, single use and are fabricated from medical grade titanium alloy (ASTM F136) and medical grade cobalt-chromium-molybdenum alloy (ASTM F1537). The purpose of this submission seek clearance for the INNOVERSE Spinal System.

Indications for Use:

The INNOVERSE Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal seqments 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:

Severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra .
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 INNOVERSE Spinal System is substantially equivalent to the predicate device (ANAX™ 5.5 Spinal System - K231737, K173524, K162189, K143417, K132101) in design, material, mechanical performance, function and intended use.

Image /page/4/Picture/14 description: The image shows the logo for "innosys". The word "inno" is in blue, and the word "sys" is in orange. The logo is simple and modern.

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1. Comparison Technological Characteristics

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

Similar indications for use
Similar design features
Incorporate the same materials
Equivalent mechanical performance

2. Performance Testing

The mechanical strength evaluation was conducted to compare data of the INNOVERSE Spinal System and predicate device (K231737, K173524, K162189, K143417, K132101). The data demonstrate that the performance of the INNOVERSE Spinal System is substantially equivalent to the predicate device.

The following tests were performed:

(1) Static compression bending test according to ASTM F1717
(2) Static torsion test according to ASTM F1717
(3) Compression bending fatique test according to ASTM F1717
(4) Axial gripping capacity test according to ASTM F1798
(5) Axial torque gripping capacity test according to ASTM F1798

3. Conclusion

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

Image /page/5/Picture/17 description: The image shows the logo for "innosys". The word "innosys" is written in a sans-serif font, with the "inno" portion in blue and the "sys" portion in orange. A blue circle is placed above the "i" in "inno", serving as the dot for the "i".

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.