The Dyflex-II is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the Dyflex-II 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 Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor and failed previous fusion (pseudarthrosis).

Device Description

The Dyflex-II is a non-cervical pedicle screw and rod system intended to facilitate the surgical correction of spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The Dyflex-II of screws, rods, cross-link connectors, and bolts that can be implanted via percutaneous surgical approach. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy (ASTM F 136). The implants will be provided non-sterile and the user need to sterilize them before use.

AI/ML Overview

This is a 510(k) premarket notification for the Dyflex-II, a thoracolumbosacral pedicle screw system. The submission aims to demonstrate substantial equivalence to a predicate device, the 4STM Spinal System (K063708).

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a pedicle screw system, and its "performance" is primarily assessed through mechanical testing to ensure structural integrity and equivalence to the predicate device.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance (Dyflex-II)
Indications for Use	Same as predicate (4STM Spinal System)	Indication for severe Spondylolisthesis (Grade 3 & 4) of L5-S1 and stabilization for acute/chronic instabilities/deformities of thoracic, lumbar, sacral spine (degenerative Spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion). Met.
Technological Characteristics	Same as predicate	Described as having the same technological characteristics. Met.
Material	Titanium Alloy (ASTM F 136)	Fabricated from titanium alloy (ASTM F 136). Met.
Components	Screw, Cross-link Connector, Rod, Bolt	Consists of screws, rods, cross-link connectors, and bolts. Met.
Sterilization Validation	In accordance with ISO 17665-1 and ISO 17665-2	Sterilization validation tests performed. Met. (Implants are provided non-sterile and user sterilizes before use)
Mechanical Testing	Performed according to ASTM F 1717, including: - Static Torsion Test - Static Compression Bending Test - Dynamic Compressive Fatigue Test	Tests performed according to ASTM F 1717 for all listed items. Results supported substantial equivalence despite minor exterior design differences. Met.
Screw Size Range (Diameters)	Diameters: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm (Predicate)	Diameters: 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0mm (Dyflex-II)
Screw Size Range (Lengths)	Lengths: 30 to 55mm (Predicate)	Lengths: 30 to 50mm (Dyflex-II)
Rod Size Range (Diameters)	Diameters: 5.5, 6.0mm (Predicate)	Diameters: 5.5, 6.0mm (Dyflex-II)
Rod Size Range (Lengths)	Lengths: 30 to 200mm (Predicate)	Lengths: 30 to 200mm (Dyflex-II)

Overall Conclusion: The Dyflex-II is deemed substantially equivalent to the predicate device based on similar indications for use, technological characteristics, material, principles of operation, and successful mechanical testing according to industry standards. The size range of the subject device is covered by or very similar to the predicate device.

The document provided is a 510(k) submission for a mechanical medical device (pedicle screw system), not an AI/software as a medical device (SaMD). Therefore, many of the requested items (e.g., test set sample size, provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to this type of device submission.

Here's why and what information is pertinent to this submission:

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

Not Applicable. This is a mechanical device. The "test set" refers to physical samples of the device components that undergo mechanical stress testing. The document does not specify the exact number of samples for each mechanical test (e.g., number of screws tested for static torsion). Data provenance is not typically described in terms of geographical origin for mechanical test results; rather, it refers to the conditions and methods under which the tests were conducted.

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

Not Applicable. Mechanical test results for a pedicle screw system do not rely on expert interpretation to establish ground truth in the way medical images or clinical outcomes do. The "ground truth" is determined by objective physical measurements against established engineering standards (ASTM F 1717).

4. Adjudication method for the test set:

Not Applicable. Since there's no expert interpretation or subjective assessment creating a "ground truth," no adjudication method is needed or described.

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:

Not Applicable. MRMC studies are relevant for devices involving human interpretation (e.g., radiologists reading images) where AI might assist. This is a mechanical implant.

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

Not Applicable. This is not an AI algorithm.

7. The type of ground truth used:

Engineering Standards / Objective Measurements. For mechanical devices, the "ground truth" is defined by compliance with established engineering standards (e.g., ASTM F 1717) and objective measurements of mechanical properties (e.g., static torsion, compressive fatigue limits).

8. The sample size for the training set:

Not Applicable. This device does not involve a "training set" in the context of machine learning.

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

Not Applicable. No training set is involved.

Summary

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November 15, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Taeyeon Medical Co., Ltd. % Priscilla Chung Official Correspondent LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine, California 92612

Re: K212700

Trade/Device Name: Dyflex-II Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: September 23, 2022 Received: September 26, 2022

Dear Priscilla Chung:

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. 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 located 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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).

Sincerely,

Colin O'neill -S

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) K212700

Device Name

Dyflex-II

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary (K212700)

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: Oct 20, 2022

1. 510K Applicant / Submitter:

TAEYEON MEDICAL Co., Ltd. 132-1 Donghwagongdan-Ro. Munmak-eup Wonju-Si, Gangwon-do, 26365, Republic of Korea

Tel:+82-33-742-7555 Fax:+82-33-742-2227

2. Submission Contact Person

LK Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160, Irvine CA 92612 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com

3. Device

Proprietary Name: Dyflex-II ●
Common Name: Pedicle Screw Spinal Fixation System ●
Classification: Class II (21 CFR 888.3070) ●
Product Code: NKB ●

4. Predicate Device

4STM Spinal System (K063708) by TAEYEON Medical Co., Ltd.

5. Description:

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implants will be provided non-sterile and the user need to sterilize them before use.

8. Indications for Use

In addition, the Dyflex-II is 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: degenerative Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

9. Substantial Equivalence Discussion:

	Subject Device	Predicate Device
Trade Name	Dyflex-II	4STM Spinal System
Manufacturer	TAEYEON Medical Co., Ltd.	TAEYEON Medical Co., Ltd.
510(k) Number	K212700	K063708
Product Code	NKB	MNI, KWQ, MNH
Indications for Use	The Dyflex-II is a pedicle screwsystem indicated for the treatment ofsevere Spondylolisthesis (Grade 3 and4) of the L5-S1 vertebra in skeletallymature patients receiving fusion byautogenous bone graft having implantsattached to the lumbar and sacral spine(L3 to sacrum) with removal of theimplants after the attainment of a solidfusion.In addition, the Dyflex-II is intended toprovide immobilization andstabilization of spinal segments inskeletally mature patients as an adjunctto fusion in the treatment of thefollowing acute and chronicinstabilities or deformities of thethoracic, lumbar and sacral spine:degenerative Spondylolisthesis withobjective evidence of neurologicalimpairment fracture dislocation	The 4STM Spinal System is a pediclescrew system indicated for the treatmentof severe Spondylolisthesis (Grade 3 and4) of the L5-S1 vertebra in skeletallymature patients receiving fusion byautogenous bone graft having implantsattached to the lumbar and sacral spine(L3 to sacrum) with removal of theimplants after the attainment of a solidfusion.In addition, the 4STM Spinal System isintended to provide immobilization andstabilization of spinal segments inskeletally mature patients as an adjunct tofusion in the treatment of the followingacute and chronic instabilities ordeformities of the thoracic, lumbar andsacral spine: degenerativeSpondylolisthesis with objective evidenceof neurological impairment, fracturedislocation scoliosis kyphosis spinal

9.1. Comparison table of the general device characteristics between the proposed and predicate device

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	scoliosis, kyphosis, spinal tumor andfailed previous fusion (pseudarthrosis).	tumor and failed previous fusion(pseudarthrosis).
Materials	Titanium Alloy(ASTM F 136)	Titanium Alloy(ASTM F 136)
Components	Screw, Cross-link Connector, Rod,Bolt	Screw, Cross-link Connector, Rod, Bolt
Screw Size	Diameters : 5.0, 5.5, 6.0, 6.5, 7.0, 7.5,8.0,8.5, 9.0mmLengths : 30 to 50mm	Diameters : 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0,8.5, 9.0mmLengths : 30 to 55mm
Rod Size	Diameter : 5.5, 6.0mmLengths : 30 to 200mm	Diameters : 5.5, 6.0mmLengths: 30 to 200mm
Mechanical Testing	Performed according to ASTM F 1717	Performed according to ASTM F 1717

*Note: Mechanical testing for the subject device and the predicate device was performed according to ASTM F 1717.

9.2. Substantial Equivalence Discussion

The Dyflex-II has the same indications for use, technological characteristics, material, and principles of operation as the predicate device. It is substantially equivalent to the predicate device in design and function. The size range of the predicate device covers the subject device range as well.

The exterior design of the subject device is slightly different from the predicate device but the test results of the performance tests support that the subject device is substantially equivalent to the predicate device.

10. Performance Tests (Non-clinical)

Sterilization Validation Tests in accordance with ISO 17665-1 and ISO 17665-2
Performance Tests in accordance with ASTM 1717 including the following test items.
- = Static Torsion Test
- · Static Compression Bending test
- · Dynamic Compressive Fatigue Test

The test results of non-clinical tests performed on the subject device supported that it is substantially equivalent to the predicate devices despite the differences.

11. Conclusions:

Based on the information provided in this premarket notification, TAEYEON MEDICAL Co., Ltd. concludes that the Dyflex-II is substantially equivalent to the predicate device as described herein in.

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.