This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The anchor and sutures is made of non-absorbable and consists of Driver Shaft(Nitinol) for anchor insertion. This product is sterilized product and single use only.

Sterile bone anchor-all suture is supplied EO gas sterile state and it was packed in tyvek and PE film.

AI/ML Overview

This document describes the Suture Wing device, an orthopedic suture anchor intended for fixation of soft tissue to bone. The acceptance criteria and the study proving the device meets these criteria are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Suture Wing device are primarily based on demonstrating substantial equivalence to a predicate device (Y-Knot RC All-suture anchor w/Two and Three #2 Hi-Fi Sutures, K133224) in terms of material, mechanical performance, sterilization, and biocompatibility. The reported device performance confirms adherence to various ASTM and ISO standards for these aspects.

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Material	Compliance with specifications for medical-grade materials.	UHMWPE (Anchor and Suture): ASTM F2848: 2017 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns. Nitinol (Driver Shaft): ASTM F2063: 2012 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants.
Mechanical Performance	Ability to withstand stress and perform as intended for bone fixation.	ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws (likely for overall anchor integrity/strength). ASTM F1839: 2008 (Reapproved 2016), Standard specification for rigid polyurethane foam for use as a standard material for testing orthopaedic devices and instruments (used for insertion testing). Bench tests conducted to verify all design specifications.
Sterilization	Effective sterilization, maintenance of sterility, and proper packaging.	ISO 11135:2014 (Ethylene oxide sterilization requirements). ISO 11138-1:2006, ISO 11138-2:2009 (Biological indicators for EO sterilization). ISO 11140-1:2014 (Chemical indicators). ISO 11737-1:2018 (Estimation of microorganisms). ISO 11737-2:2009 (Tests of sterility). ISO 11607-1:2006/AMD1:2014, ISO 11607-2:2006/AMD1:2014 (Packaging for terminally sterilized medical devices). ASTM F1980:2016 (Accelerated aging of sterile barrier systems). ASTM F88/F88M:2015 (Seal strength). ASTM F1929:2015 (Detecting seal leaks).
Biocompatibility	Absence of harmful biological responses.	USP <85> Bacterial Endotoxin Test. USP <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests. USP <151> Pyrogenicity Test. ISO 10993-11: Tests for systemic toxicity.
Insertion Performance	Successful and safe insertion capability.	FDA guidance: Bone Anchors Premarket notification (510(K)) Submissions. ASTM F1839: 2008 (Reapproved 2016) (used as a standard material for testing orthopaedic devices and instruments for insertion).
Substantial Equivalence	Demonstrating that the device is as safe and effective as the predicate device (K133224) based on intended use, operating principles, material, structure, product size, sterilization, single use/reuse, packaging, and shelf-life.	The device demonstrates "Same" or "Similar" equivalence across all criteria shown in Table 1 (page 5 of the document). This includes identical product code, regulatory class, regulation number, intended use, operating principles, sterilization method, single use status, packaging, and shelf-life. Materials (UHMWPE for anchor/suture) and structure are similar, and product size (1.7mm/2.8mm vs 1.8mm/2.8mm) is also similar and deemed acceptable.

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

The provided document describes bench tests conducted to verify design specifications and compliance with various standards. It does not mention a "test set" in the context of patient data or clinical studies. The tests are focused on physical and chemical properties of the device.

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

Not applicable. The document describes bench testing against established industry standards for material, mechanical, sterilization, and biocompatibility properties, not the establishment of ground truth from expert clinical assessment.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation or clinical adjudication.

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. This document pertains to a physical medical device (suture anchor), not an AI-powered diagnostic or assistive technology.

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

Not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by adherence to recognized industry standards (ASTM, ISO, USP) and FDA guidance for bone anchors. For example:

Material properties: Compliance with ASTM F2848 and F2063 ensures the materials meet specific requirements for medical use.
Mechanical strength: Conformance to ASTM F543 and demonstration through bench tests indicates the device's structural integrity.
Sterility: Meeting ISO 11135 and related standards confirms the device is sterile and remains so.
Biocompatibility: Tests like USP <85> and ISO 10993-11 verify the absence of harmful biological reactions.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set. The "study" described involves physical testing of the device.

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

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

Summary

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June 7, 2021

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

Osteonic Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #303, 142, Gasan digital 1-ro Geumcheon-gu, Seoul 08507 Korea, Republic of

Re: K202663

Trade/Device Name: Suture Wing Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 4, 2021 Received: May 6, 2021

Dear Sanglok 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 (Act) that do not require approval of a premarket approval application (PMA). You mav, 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,

Pooja Panigrahi -S

for

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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) K202663

Device Name Suture Wing

Indications for Use (Describe)

Suture wing is intended for fixation of soft tissue to bone, using suture, in orthopedic surgery.

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)

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Image /page/3/Picture/0 description: The image shows the logo for Osteonic. The logo consists of a blue geometric shape on the left and the word "OSTEONIC" in bold, black letters on the right. Below the word "OSTEONIC" is the tagline "The Medical Explorer" in a smaller, lighter font.

The assigned 510(k) Number: K202663

01. Date of Submission: 2020.09.11

02. Applicant

Dakyung Ham OSTEONIC Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho, 1202Ho, 1206Ho, 38 Digital-ro 29-gil, Guro-gu, Seoul, Korea, 102Ho, 103Ho, 24, Digital-ro 27-gil, Guro-gu, Seoul, Korea TEL: +82-2-6902-8456 FAX: +82-2-6902-8401 Email: dakham@osteonic.com

03. Submission Correspondent

Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org

04. Subject Device Identification

Trade Name: Suture Wing Common Name: Sterile bone anchor-all suture Classification Name: fastener, fixation, non-biodegradable, soft tissue Product Code: MBI Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Device Class: II

05. Indication for use

Suture wing is intended for fixation of soft tissue to bone, using suture, in orthopedic surgery.

06. Predicate devices

Predicate device 510(k) Number: K133224 Device Name: Y-Knot RC All-suture anchor w/Two and Three #2 Hi-Fi Sutures Manufacturer: ConMed Corporation

07. Device Description

Sterile bone anchor-all suture is supplied EO gas sterile state and it was packed in tyvek and PE film.

08. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the subject device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the subject device complies with the following standards:

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Image /page/4/Picture/1 description: The image contains a logo for Osteonic. The logo consists of a blue geometric shape on the left and the word "OSTEONIC" in bold, dark gray letters on the right. Below "OSTEONIC" is the tagline "The Medical Explorer" in a smaller, lighter gray font.

▪ Material

ASTM F2848: 2017 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns - ASTM F2063: 2012 Standard Specification for Wrought Nickel-Titanium Shape Memory Alloys for Medical Devices and Surgical Implants

▪ Mechanical performance

ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws
ASTM F1839: 2008 (Reapproved 2016), Standard specification for rigid polywethane foam for use as a standard material for testing orthopaedic devices and instruments

▪ Sterilization, shelf-life and packaging for sterile product

ISO 11135:2014, Sterilization of health-care products Ethylene oxide Requirements for the development validation and routine control of a sterilization and routine control of a sterilization process for medical devices
ISO 11138-1:2006, Sterilization of health care products Biological indicators Part 1: General requirements - ISO 11138-2:2009, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11140-1:2014, Sterilization of health care products Chemical indicators Part 1: General requirements
ISO 11737-1:2018 Sterilization of medical devices Microbiological methods- Part 1: Estimation of microorganisms on products
ISO 11737-2:2009 Sterilization of medical devices Microbiological methods- Part 2. Tests of sterility performed in the validation of a sterilization process
ISO 11607-1:2006/AMD1:2014 Packaging for terminally sterilized medical devices part 1: requirements for materials, sterile barrier systems and packaging system
ISO 11607-2:2006/AMD1:2014 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
ASTM F1980:2016 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F88/F88M:2015 Standard test method for seal strength of flexible barrier materials.
ASTM F1929:2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

▪ Bacterial Endotoxin

USP <85> Bacterial Endotoxin Test
USP <161> Medical Devices-Bacterial Endotoxin and Pyrogen Tests
Material mediated pyrogenicity
USP <151> Pyrogenicity Test
ISO 10993-11: Tests for systemic toxicity

▪ Insertion test

FDA guidance : Bone Anchors Premarket notification (510(K)) Submissions
ASTM F1839: 2008 (Reapproved 2016), Standard specification for rigid polyurethane foam for use as a standard material for testing orthopaedic devices and instruments

09. Substantially Equivalent Conclusion

Table 1: Substantial Equivalence Comparison

ProductName	SUBJECT Device	PREDICATE DeviceY-Knot RC All-suture anchor w/Two andThree #2 Hi-Fi Sutures (K133224)	EquivalenceDiscussion
Productcode	MBI	MBI	Same
Regulatoryclass	Class II	Class II	Same
RegulationNumber	21 CFR 888.3040	21 CFR 888.3040	Same

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Image /page/5/Picture/1 description: The image contains a logo for a company called OSTEONIC. The logo consists of a blue geometric shape resembling a stylized diamond or cube, positioned to the left of the company name. Below the company name, there is a tagline that reads "The Medical Explorer" in a smaller font size.

Intended use	Suture wing is intended for fixation of softtissue to bone, using suture, in orthopedicsurgery.	The non-absorbable suture anchors areintended to reattach soft tissue to bone inorthopedic surgical procedures.	Same
OperatingPrinciples	Bone fixation anchor that ties soft tissuessuch as ligament, tendon, and the articularcapsules to bone.	Bone fixation anchor that ties soft tissuessuch as ligament, tendon, and the articularcapsules to bone.	Same
Material	Anchor and suture:UHMWPE	Anchor and suture:UHMWPE	Similar
Structure	This product consists of a non-absorbable allsuture and driver shaft and handle.	This product consists of a non-absorbable allsuture and driver shaft and handle.	Similar
ProductSize	1.7mm/ 2.8mm	1.8mm/ 2.8mm	Similar
Sterilization	Sterile (EtO sterilization)	Sterile (EtO sterilization)	Same
Single Use/Reuse	Single use	Single use	Same
Packaging	1 EA / BOX	1 EA / BOX	Same
Shelf -life	5 Years	5 Years	Same

Based on above, the subject device, Suture Wing, is Substantially Equivalent (SE) to the predicate devices, Y-Knot RC All-suture anchor w/Two and Three #2 Hi-Fi Sutures (K133224) in respect of safety and effectiveness.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.