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

Device Description

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 text is a 510(k) premarket notification for a medical device called "Fix2Lock (PEEK Self Punching)". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than providing the detailed acceptance criteria and study results for a new, AI-powered device's performance.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, MRMC studies, and training set specifics cannot be extracted from this document. This type of information is typically found in study reports or technical documentation submitted for devices that involve AI/ML components requiring performance validation against defined metrics.

The document primarily discusses:

Device Identification: Fix2Lock (PEEK Self Punching), a Class II device for orthopedic surgery.
Intended Use: Fixation of soft tissue to bone using suture (shoulders, knees, foot/ankle, hand/wrist, elbow).
Substantial Equivalence (SE) Claim: The subject device (K231322) is substantially equivalent to a predicate device (K202763), and a reference device (K081511).
Non-Clinical Tests: Bench tests were conducted to verify design specifications and SE to the predicate device, citing compliance with various ASTM and ISO standards for material, mechanical performance, sterilization, shelf life, packaging, and bacterial endotoxin (e.g., ASTM F2026, F543, ISO 11135, 11607, USP <85>).
Comparison Table: Details similarities and differences in product code, regulatory class, intended use, operating principles, material, structure, product size, sterilization, single use/reuse, packaging, and shelf life between the subject, predicate, and reference devices.

In essence, this document is a regulatory submission for a traditional medical device demonstrating equivalence, not a performance study for an AI/ML diagnostic or assistive device that would have the requested acceptance criteria and study design details.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with an eagle and text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.

June 7, 2023

Osteonic Co., Ltd. % Sanglok Lee Manager Wise Company Inc. #507, #508, 166 Gasandigital 2-ro, Geumcheon-gu Seoul, 08507 Korea, South

Re: K231322

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: May 8, 2023 Received: May 8, 2023

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

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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) 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 medical devices and radiation-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,

Sara S. Thompson -S

For

Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231322

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, knees, foot/ankle, hand/wrist and elbow.

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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Date of Submission: 2023.06.07

01. Applicant

OSTEONIC Co., Ltd.

405Ho, 505-2Ho, 505-3Ho, 508Ho, 902Ho, 1004Ho, 1005Ho, 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

02. Submission Correspondent

Sanglok, Lee Wise COMPANY Inc. #507, #508, 166 Gasan digital 2-ro, Geumcheon-gu, Seoul, Korea TEL: +82 70 8812 3619 / +82 2 831 3615 FAX: +82 50 4031 3619 Email: info@wisecompany.org

03. 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 fastener Classification Product Code: MBI Panel: Orthopedic Regulation Number: 21 CFR 888.3040 Device Class: II

04. Predicate Device

510(k) Number: K202763 Device Name: Fix2Lock (PEEK Self Punching) Manufacturer: Osteonic Co., Ltd.

05. Reference Device

510(k) Number: K081511 Device Name: 2.0 PK Suture anchor T and 2.0 PK Suture anchor S Manufacturer: Smith &Nephew, Inc.

510(k) Number: K202806

Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Manufacturer: Osteonic Co., Ltd.

06. Device Description

07. Indication for use

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

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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 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 population 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

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09. Comparison of Technological Similarities and Differences Table 1: Substantial Equivalence Comparison

ProductName	Modified(Subject) DeviceFix2Lock (PEEK SelfPunching), K231322	Unmodified(Predicate)DeviceFix2Lock (PEEK SelfPunching), K202763	REFERENCE Device2.0 PK Suture anchor T and2.0 PK Suture anchor S,K081511	EquivalenceDiscussion
Productcode	MBI	MBI	MBI	Same
Regulatoryclass	Class II	Class II	Class II	Same
RegulationNumber	21 CFR 888.3040	21 CFR 888.3040	21 CFR 888.3040	Same
Intendeduse	Fix2Lock is intended usefor fixation of soft tissue tobone, using suture, in thefollowing procedure;Orthopedic surgery forshoulders, knees,foot/ankle, hand/wrist andelbow.	Fix2Lock is intended use forfixation of soft tissue tobone, using suture, in thefollowing procedure;Orthopedic surgery forshoulders and knees.	The 2.0 PK Suture Anchor Tand 2.0 PK Suture Anchor Sis intended for use forreattachment of soft tissueto bone for the followingindication:Shoulder: Capsularstabilization - Bankartrepair, Anterior shoulderinstability, Slap lesion repair,Capsular shift orcapsulolabralreconstruction,Acromilavicular separationrepairs, Deltoid repairs,Rotator cuff repairs andBiceps tenodesisFoot/ankle: Hallux valgusrepairs, Medial or lateralinstabilityrepairs/reconstruction,Achilles tendonrepairs/reconstruction, Mid-foot reconstruction,Metatarsal ligament/tendonrepairs/reconstruction andBunionectomy.Elbow, Wrist, and Hand:Biceps tendonreattachment, Ulnar or radialcollateral ligamentreconstruction, Lateralepicondylitis repair, andScapholunate ligamentreconstruction.Knee: Extra-capsularrepairs - Medial collateralligament, Lateral collateralligament, Posterior obliqueligament, Patellarrealignment and tendonrepairs - Vastus medialisobliquus advancement andIliotibial band tenodesis.	Same
OperatingPrinciples	This product is used fororthopedic surgery, whichsoft tissue fix such asligaments, tendons, andcapsules to bone.	This product is used fororthopedic surgery, whichsoft tissue fix such asligaments, tendons, andcapsules to bone.	Same
Material	PEEK anchor and non-absorbable sutures,needle	PEEK anchor and non-absorbable sutures.	PEEK. Non-absorbablesuture, Stainless steelneedle.	Similar
Structure	This product consists of animplanted anchor, non-absorbable suture, drivershaft and handle	This product consists of animplanted anchor, non-absorbable suture, drivershaft and handle	The 2.0 PK Suture Anchor Tand the 2.0 PK SutureAnchor S consist of a non-absorbable suture anchorwith attached non-absorbable suture(s)preassembles to a stainlesssteel insertion device, and isprovided sterile, for singleuse only. Both anchormodels achieve fixation viaribbed/threaded designcharacteristics that areconsistent with the repair ofsoft tissue to bone.	Same
ProductSize	2.3mm, 4.5mm, 4.8mm,5.5mm type	4.5mm, 5.5mm type	2.03mm	Similar
Sterilization	Sterile (EtO sterilization)	Sterile (EtO sterilization)	Sterile	Same
Single Use/Reuse	Single use	Single use	Single use	Same
Packaging	1 EA / BOX	1 EA / BOX	1 EA / BOX	Same
Shelf life	3Years	5Years		Similar

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K231322

The Product Size of subject device is similar with the predicate device and the safety was evaluated as the performance bench test.

Reference device had been added to demonstrate the equivalency with the marketed device. This is to resolve that the needles are not applied for unmodified device.

10. Substantially Equivalent Conclusion

Based on above, the subject device, Fix2Lock (PEEK Self Punching), is determined to be Substantially Equivalent (SE) to the Unmodified(Predicate) device, Fix2Lock (PEEK Self Punching) (K202763) ,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.