This product is used for orthopedic surgery, which soft tissue fix such as ligaments, tendons, and capsules to bone. The implant part is made of PEEK (polyether ether ketone, ASTM F2026) with non-absorbable suture and consists of Driver Handle and Driver Shaft for anchor insertion. This product is sterilized product and single use only.

AI/ML Overview

The provided document is a 510(k) summary for the medical device Fix2Lock (PEEK Self Punching). This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy. It primarily details a non-clinical bench study to verify design specifications and compliance with material and mechanical performance standards.

Therefore, many of the requested sections regarding clinical study design, sample sizes for test/training sets, expert ground truth adjudication, MRMC studies, and standalone performance are not applicable or not available in this type of submission.

Here's the information that can be extracted or inferred from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Type	Acceptance Criteria (Standard Reference)	Reported Device Performance (Compliance)
Material	ASTM F2026: PEEK polymers for surgical implant applications	Complies with standard
	ASTM F2848: Medical-Grade UHMWPE Yarns and Surgical Implants	Complies with standard
Mechanical Performance	ASTM F543: Metallic medical bone screws	Complies with standard
Sterilization	ISO 11135: Ethylene oxide sterilization	Complies with standard
	ISO 11138-1: Biological indicators (General)	Complies with standard
	ISO 11138-2: Biological indicators (EtO)	Complies with standard
	ISO 11140-1: Chemical indicators (General)	Complies with standard
	ISO 11737-1: Microbiological methods (Estimation)	Complies with standard
	ISO 11737-2: Microbiological methods (Sterility tests)	Complies with standard
Packaging	ISO 11607-1: Packaging for terminally sterilized medical devices (materials)	Complies with standard
	ISO 11607-2: Packaging for terminally sterilized medical devices (validation)	Complies with standard
	ASTM F1980: Accelerated Aging of Sterile Barrier Systems	Complies with standard
	ASTM F88/F88M: Seal strength of flexible barrier materials	Complies with standard
	ASTM F1929: Detecting Seal Leaks by Dye Penetration	Complies with standard
Bacterial Endotoxin	USP <85>: Bacterial Endotoxin Test	Complies with standard
	USP <161>: Medical Devices-Bacterial Endotoxin and Pyrogen Tests	Complies with standard
Functional Equivalence	To be Substantially Equivalent (SE) to predicate device (K143745) in all aspects of safety and effectiveness, including intended use, product code, regulatory class, regulation number, operating principles, material, structure, product size, sterilization, single use/reuse, packaging, and shelf-life.	Deemed Substantially Equivalent (SE)

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

Test Set Sample Size: Not specified. The study described is a bench test, and the number of units tested to demonstrate compliance with the listed standards is not provided.
Data Provenance: Not applicable, as this is a bench test for materials, mechanical properties, and sterilization, not a clinical study with patient data.

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

Not applicable. Ground truth as typically understood in clinical studies (e.g., disease presence/absence determined by experts) is not relevant for this type of bench testing. Compliance with engineering standards and material specifications would be assessed by engineers and quality control personnel.

4. Adjudication method for the test set

Not applicable. There is no mention of adjudication for the bench tests. Compliance is determined against established engineering and material standards.

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 is a medical device for orthopedic fixation, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the bench tests, the "ground truth" is defined by the specifications and requirements stipulated in the referenced international and national standards (e.g., ASTM F2026 for PEEK, ISO 11135 for sterilization). The device's performance is compared against these quantitative and qualitative standard requirements.
For the overall submission, the "ground truth" for demonstrating marketability is the substantial equivalence to the predicate device, Arthrex Corkscrew and SwiveLock Suture Anchors (K143745).

8. The sample size for the training set

Not applicable. This is a physical medical device and not an AI/machine learning model 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 this device.

Summary

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June 4, 2021

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

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

Re: K202763

Trade/Device Name: Fix2Lock (PEEK Self Punching) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 17, 2020 Received: September 21, 2020

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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

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) K202763

Device Name Fix2Lock (PEEK Self Punching)

Indications for Use (Describe)

Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders and knees.

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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Image /page/3/Picture/0 description: The image contains a logo with a geometric shape on the left and text on the right. The geometric shape is a blue, three-dimensional structure composed of interconnected lines, resembling a stylized cube or diamond. To the right of the shape, the word "OSTEONIC" is written in bold, dark blue letters. Below "OSTEONIC", there is a smaller line of text that reads "The Medical Explorer".

510(k) Summary

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Image /page/4/Picture/1 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, dark blue letters on the right. Below the word "OSTEONIC" is the tagline "The Medical Explorer" in a smaller, lighter font.

The assigned 510(k) Number: K202763

01. Date of Submission: 2020.09.17

02. Applicant

Dakyung Ham OSTEONIC Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 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: Fix2Lock (PEEK Self Punching) Common Name: fastener, fixation, non-biodegradable, soft tissue Classification Name: Smooth or threaded metallic bone fixation fastner Product Code: MBI Panel: Orthopedic Regulation Number: 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastner Device Class: II

05. Indication for use

Fix2Lock is intended use for fixation of soft tissue to bone, in the following procedure;Orthopedic surgery for shoulders and knees.

06. Predicate devices

Predicate device 510(k) Number: K143745 Device Name: Arthrex Corkscrew and SwiveLock Suture Anchors Manufacturer: Arthrex, Incorporated

Reference device 510(k)Number: K202883 Device Name: Sterile bone screw (PEEK ACL screw) Manufacturer: OSTEONIC Co., Ltd.

07. Device Description

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Image /page/5/Picture/1 description: The image contains the logo for Osteonic. The logo features a blue geometric shape resembling a stylized diamond or cube, with a smaller shape inside. To the right of the geometric shape, the word "OSTEONIC" is written in bold, dark gray letters. Below "OSTEONIC", the phrase "The Medical Explorer" is written in a smaller, lighter font.

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:

▪ Material

ASTM F2026: 2017 Standard specification for polyetheretherketone(PEEK) polymers for surgical implant applications - ASTM F2848: 2017 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns and Surgical Implants

· Mechanical performance

ASTM F543: 2013 Standard specification and test methods for metallic medical bone screws
= 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

09. Substantially Equivalent Conclusion

Table 1: Substantial Equivalence Comparison

ProductName	SUBJECT Device	PREDICATE DeviceArthrex Corkscrew and SwiveLock SutureAnchors (K143745)	EquivalenceDiscussion
Productcode	MBI	MBI	Same
Regulatoryclass	Class II	Class II	Same
RegulationNumber	21 CFR 888.3040	21 CFR 888.3040	Same
Intended use	Fix2Lock is intended use for fixation of softtissue to bone, using suture, in thefollowing procedure; Orthopedic surgery forshoulders and knees.	The Arthrex Corkscrew and SwiveLockSuture Anchors are intended to be used forfixation of suture(soft tissue) to bone in theshoulder, foot/ankle, hip, knee, hand/wrist,and elbow in the orthopedic surgicalprocedures.	Same
OperatingPrinciples	This product is used for orthopedic surgery,which soft tissue fix such as ligaments,tendons, and capsules to bone	Bone fixation anchor that ties soft tissuessuch as ligament, tendon, and the articularcapsules to bone.	Same

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Image /page/6/Picture/1 description: The image contains the logo for Osteonic. The logo consists of a blue geometric shape resembling a stylized diamond or cube structure. To the right of the shape, the word "OSTEONIC" is written in bold, dark lettering. Below "OSTEONIC", the tagline "The Medical Explorer" is written in a smaller, lighter font.

Material	PEEK anchor and non-absorbable sutures	PEEK anchor and non-absorbable sutures	Similar
Structure	This product consists of an implantedanchor, non-absorbable suture, driver shaftand handle	This product consists of an implantedanchor, non-absorbable suture, driver shaftand handle	Similar
ProductSize	4.5mm type / 5.5mm type	4.75mm type / 5.5mm type	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	5Years	5 Years	Same

Based on above, the subject device, Fix2Lock (PEEK Self Punching), is determined to be Substantially Equivalent (SE) to the predicate devices, Arthrex Corkscrew and SwiveLock Sutures (K143745) 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.