The Sterile bone screw (PEEK ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery.

Knee

· ACL repairs
· PCL repairs
Extra-capsular repairs
- Medial collateral ligament
- Lateral collateral ligament
Posterior oblique ligament
Patellar realignment and tendon repairs - Vastus medialis obliquus advancement
Iliotibial band tenodesis

Device Description

The Sterile bone screw (PEEK ACL screw) is a bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

The implanted screw is made of PEEK (poly-ether-ether-ketone, ASTM F2026).

The Sterile bone screw (PEEK ACL screw) is supplied gamma irradiation sterile state and it is packed in Tyvek Pouch.

AI/ML Overview

The provided text describes the 510(k) summary for a medical device (Sterile bone screw (PEEK ACL screw)) seeking substantial equivalence to a predicate device. This document focuses on the mechanical and material performance of the medical device itself, rather than the performance of an AI algorithm or software.

Therefore, many of the requested elements for an AI/ML device approval (such as acceptance criteria for AI performance, sample size for test/training sets, expert ground truth establishment for AI, MRMC studies, etc.) are not applicable to this document.

However, I can extract the acceptance criteria and performance data for the device's mechanical properties as presented in the document.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are implicitly defined by the "PASS" result for each test conducted according to the specified ASTM standards. The study proves the device meets the acceptance criteria by indicating "PASS" for all relevant tests.

No.	Test Article	Test Method	Acceptance Criteria (Implicit)	Reported Performance
1	Axial Pullout Strength	ASTM F543-A3.Test Method for Determining the Axial Pullout Strength of Medical Bone Screws.	Meets ASTM F543-A3 standards	PASS
2	Torsional Yield Strength	ASTM F543-A1.Test Method for Determining the Torsional Properties of Metallic Bone Screws.	Meets ASTM F543-A1 standards	PASS
3	Driving Torque Insertion	ASTM F543-A2.Test Method for Driving Torque of Medical Bone Screws.	Meets ASTM F543-A2 standards	PASS
	Driving Torque Removal	ASTM F543-A2.Test Method for Driving Torque of Medical Bone Screws.	Meets ASTM F543-A2 standards	PASS
4	Fatigue	After fully inserting the screw with the tendon into the fixed artificial bone (20PCF), a fatigue tensile load of 70 to 220N on the tendon is repeated 1000 cycles at 1 Hz.	Withstands 1000 cycles of specified fatigue loading	PASS

2. Sample Size and Data Provenance for Test Set

The document states: "All specimens selected (worst-case) to verify the performance of the screw met the test criteria." However, it does not specify the exact sample size (number of screws tested) for each test. The data provenance is a bench test, implying ex-vivo lab testing, not human patient data. There is no information regarding the country of origin of this specific test data, but the company is based in South Korea.

3. Number of Experts and Qualifications for Ground Truth

Not applicable as this is a mechanical device performance test, not an AI/ML algorithm requiring expert ground truth for interpretation of images or clinical data. The "ground truth" is established by the physical properties and performance of the screw itself, measured against established engineering standards.

4. Adjudication Method for Test Set

Not applicable. As this is a bench test for mechanical properties, there is no need for human adjudication of results in the traditional sense, beyond verifying that the test was conducted correctly according to the standard and the measurements fall within passing ranges.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device, so no MRMC study was performed. The "improvement" measured is an engineering performance against a standard, not an improvement in human reader performance.

6. Standalone (Algorithm Only) Performance

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

7. Type of Ground Truth Used

The ground truth used for this device is based on established engineering and medical device standards (ASTM and ISO standards) for material properties, mechanical performance, sterilization, and biocompatibility. The "worst-case" specimens were tested against these pre-defined, quantitative standards.

8. Sample Size for Training Set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable. As above, no training set for an AI/ML algorithm was used.

Summary

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November 25, 2020

Image /page/0/Picture/1 description: The image shows 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 the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

Osteonic Co., Ltd. % Sanglok Lee Manager WISE COMPANY Inc. #507-508, 166 Gasan digital 2-ro Geumcheon-gu, Seoul, Republic of Korea 08503

Re: K202883

Trade/Device Name: Sterile bone screw (PEEK ACL screw) Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: September 24, 2020 Received: September 28, 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,

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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1206Ho. 38. Digital-ro 29 Tel: +82(2)-6902-8400 Fax: +82(2)-6902-8401 Home page: http://www.os

83 Page 1 of 4

The assigned 510(k) Number: K202883

1. 510(k) Summarv Date: 11. 23. 2020

2. Applicant

Sung-moo Hwang

OSTEONIC Co., Ltd. 303Ho, 405Ho, 505-3Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho, 1206Ho, 38 Digital-ro 29-gil, Guro-gu, Seoul, Korea, 102Ho, 103Ho, 24, Digital-ro 27-gil, Guro-gu, Seoul, Korea TEL: +82-2-6902-8426 FAX: +82-2-6902-8401 Email: sungmhwang@osteonic.com

3. Submission Correspondent

Sang-lok, 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

4. Subject Device Identification

1. Trade Name: Sterile bone screw (PEEK ACL screw)
1. Common Name: Sterile bone screw (PEEK ACL screw)
1. Classification Name: fastener, fixation, non-biodegradable, soft tissue
1. Product Code: MBI
1. Panel: Orthopedic
1. Regulation Number: 21 CFR 888.3040
1. Device Class: II

5. Indication for use

The Sterile bone screw (PEEK ACL screw) is a fixation screw that fixes soft tissue such as ligaments, tendons, and the articular capsules to bone, and is used in orthopedic surgery.

Knee

· ACL repairs
· PCL repairs
Extra-capsular repairs
- Medial collateral ligament
- Lateral collateral ligament

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Image /page/4/Picture/0 description: The image shows the Osteonic logo. The logo consists of a blue diamond shape with a white line running through it. To the right of the diamond is the word "OSTEONIC" in a dark gray sans-serif font. The logo is simple and modern.

K202883 Page 2 of 4

Posterior oblique ligament
Patellar realignment and tendon repairs - Vastus medialis obliquus advancement
Iliotibial band tenodesis

6. Predicate devices

1. 510(k) Number: K083635
1. Device Name: Biosure PK Interference Screw
1. Manufacturer: Smith&Nephew PK Interference Screw

7. Device Description

The Sterile bone screw (PEEK ACL screw) is a bone fixation screw that fixes soft tissues such as ligament, tendon, and the articular capsules to bone, and is used in orthopedic surgery.

The implanted screw is made of PEEK (poly-ether-ether-ketone, ASTM F2026).

The Sterile bone screw (PEEK ACL screw) is supplied gamma irradiation sterile state and it is packed in Tyvek Pouch.

8. Non-Clinical Test Conclusion

1) General Information

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 Poly-ether-ether-ketone(PEEK)Polymer for Surgical Implant Applications

· Mechanical Performance

ASTM F543:17 Standard Specification and test method for metallic bone screws
= Sterilization, Shelf-life and Packaging for Sterile Product
ISO 11138-1:2006, Sterilization of health care products Biological indicators -- Part 1: General requirements
ISO 11140-1:2014, Sterilization of health care products Chemical indicators Part 1: General requirements
ISO 11137-1:2006. Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2013, Sterilization of health care products Radiation Part 2: Establishing the sterilization dose
ISO 11137-3:2017, Sterilization of health care products Radiation Part 3: Guidance on dosimetric aspects of development, validation and routine control
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

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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

2) Summary of Biocompatibility

The Sterile bone screw (PEEK ACL screw) has been evaluated for biocompatibility according to ISO 10993.

3) Summary of Performance

All specimens selected (worst-case) to verify the performance of the screw met the test criteria. Therefore, the performance of the entire model was proven.

No.	Test Article	Test Method	Result
1	Axial Pullout Strength	ASTM F543-A3.Test Method for Determining the AxialPullout Strength of Medical Bone Screws.	PASS
2	Torsional Yield Strength	ASTM F543-A1.Test Method for Determining theTorsional Properties of Metallic Bone Screws.	PASS
3	Driving TorqueInsertionRemoval	ASTM F543-A2.Test Method for Driving Torque of MedicalBone Screws.	PASS
4	Fatigue	After fully inserting the screw with the tendon into the fixedartificial bone (20PCF), a fatigue tensile load of 70 to 220Non the tendon is repeated 1000 cycles at 1 Hz.	PASS

9. Substantially Equivalent Conclusion

Table 1: Substantial Equivalence Comparison

ProductName	SUBJECT Device	PREDICATE DeviceBiosure PK Interference Screw (K083635)	EquivalenceDiscussion
Productcode	MBI	MBI	Same
Regulatoryclass	Class II	Class II	Same
RegulationNumber	21 CFR 888.3040	21 CFR 888.3040	Same
IntendedUse	The Sterile bone screw (PEEKACL screw) is a fixation screwthat fixes soft tissue such asligaments, tendons, and thearticular capsules to bone, and isused in orthopedic surgery	The BIOSURE PK Screw is indicated forthe reattachment of ligament, tendon, softtissue, or bone to bone during cruciateligament reconstruction surgeries of theknee. All screws with a diameter of 9 mmor less and a length of 25 mm or less are also	Same
	Knee• ACL repairs• PCL repairs• Extra-capsular repairs– Medial collateral ligament– Lateral collateral ligament– Posterior oblique ligament• Patellar realignment and tendonrepairs– Vastus medialis obliquusadvancement• Iliotibial band tenodesis	intended for use in the followingprocedures:Knee• ACL repairs• PCL repairs• Extra-capsular repairs– Medial collateral ligament– Lateral collateral ligament– Posterior oblique ligament• Patellar realignment and tendon repairs– Vastus medialis obliquus advancement• Iliotibial band tenodesisShoulder• Acromioclavicular separation repairs• Biceps tenodesisFoot and Ankle• Medial or lateral instability repairs/reconstructions• Achilles tendon repairs/reconstructions• Metatarsal ligament/tendon repairs/reconstructions• Flexor hullucis longus (FHL)• Tendon transfersElbow, Wrist, and Hand• Biceps tendon reattachment• Ulnar or radial collateral ligamentreconstructions• Lateral epicondylitis repair• Scapholunate ligament reconstruction• Tendon transfers• Carpomedicarpal joint arthroplasty
OperatingPrinciples	The Sterile bone screw (PEEKACL screw) is a fixation screwthat fixes soft tissue such asligaments, tendons, and thearticular capsules to bone, and isused in orthopedic surgery.	The Biosure PK Interference Screw is afixation screw that fixes soft tissue such asligaments, tendons, and the articularcapsules to bone, and is used in orthopedicsurgery.	Same
Material	PEEK 100% (Optima PEEK)	PEEK 100% (Optima PEEK)	Same
ProductSize	Ø 7.0 x (25,30) mmØ 8.0 x (25,30) mmØ 9.0 x (25,30) mmØ 10.0 x (25,30) mm	Ø 6.0 x (20,25,25(R)) mmØ 7.0 x (20,25,25(R),30) mmØ 8.0 x (20,25,25(R),30,35) mmØ 9.0 x (20,25,30,35) mmØ 10.0 x (20,25,30,35) mmØ 11.0 x (25,30,35) mmØ 12.0 x 35 mm	Similar
Sterilization	Sterile (Gamma sterilization)	Sterile (Gamma 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

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Image /page/6/Picture/0 description: The image shows the Osteonic logo. The logo consists of a blue geometric shape on the left and the word "OSTEONIC" in gray on the right. The geometric shape is a diamond with a stylized "O" inside.

K202883 Page 4 of 4

Based on above, the subject device, Sterile bone screw (PEEK ACL screw), is determined to be Substantially Equivalent (SE) to the predicate devices, Biosure PK Interference Screw (K083635) 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.