Sterile bioabsorbable bone screw (Biocomposite 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(Cruciate ligament reconstruction procedures).

Device Description

The Sterile bioabsorbable bone screw (Biocomposite ACL screw) is an absorbable 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 poly(L-lactide-co-glycolide), PLGA and tri-calciumphosphate(S-TCP). Poly(L-lactide-co-glycolide), PLGA is gradually decomposed in vivo by hydrolysis and eventually excreted in carbon dioxide and water. Tri-calciumphosphate(ß-TCP) is gradually degraded in vivo by hydrolysis and eventually re-used as a calcium source.

Sterile bioabsorbable bone screw (Biocomposite ACL screw) is supplied EO gas sterile state and it is packed in Aluminum Pouch.

AI/ML Overview

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than clinical performance studies. Therefore, the typical information sought for AI/CADe devices (like ground truth establishment, reader studies, effect size with AI assistance, training set details, etc.) is not applicable here because this is a mechanical medical device, not an AI/CADe system.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

The acceptance criteria are implied by adherence to referenced standards and successful completion of specific mechanical tests. The reported device performance is simply "PASS" for all tested criteria, indicating it met the established benchmarks.

No.	Test Article	Acceptance Criteria (Implied by standard and test method)	Reported Device Performance
1	Axial Pullout Strength	Test referring ASTM F2502-A3.Test Method for Axial Pullout of Absorbable Bone Screws. After fully inserting the screw into the artificial bone (20PCF), Apply tensile load to the specimen at a rate 5mm/min until the screw fails or releases from the block. Measure the maximum load. (Specific performance values not quantifiable from the text, but the test was deemed successful.)	PASS
2	Torsional Yield Strength	Test referring ASTM F2502-A1.Test Method for Determining the Torsion Properties of Absorbable Bone Screws. After placing the specimen in the holding device, Rotate the screw in inserting direction at a rate of 1 revolution/min. Torsional yield strength is determined by an off-set method (2 degree off-set) on the torque versus rotation angle curve measured in the test. (Specific performance values not quantifiable from the text, but the test was deemed successful.)	PASS
3	Driving Torque	Test referring ASTM F2502-A2.Test Method for Driving Torque of Absorbable Bone Screws. Make a hole in the fixed artificial bone (20PCF) using an instrument compatible with the product. Measure the maximum strength when the screw is inserted 4 revolutions at a rate of 5 revolutions per minute. * Inserting load (axial load) = 1.14kgf. (Specific performance values not quantifiable from the text, but the test was deemed successful.)	PASS
4	Degradation testing	Mechanical performance assessed after degradation according to ISO 13781. (Specific performance values not quantifiable from the text, but the test was deemed successful.)	PASS
5	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. (Specific performance values not quantifiable from the text, but the test was deemed successful.)	PASS

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

The document states "All specimens selected (worst-case) to verify the performance of the test criteria established based on literatures and comparison with the predicate device." However, specific numerical sample sizes for each test are not provided. The provenance of the test samples (e.g., country of origin, retrospective/prospective) is also not specified, though it is implied these are manufactured device samples undergoing bench testing.

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

This information is not applicable as the document describes bench testing for a mechanical device. The "ground truth" here is determined by objective mechanical measurements against established ASTM and ISO standards, not expert interpretation of medical images or conditions.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the document describes bench testing for a mechanical device. There is no human adjudication process involved in these mechanical performance tests.

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

This information is not applicable as this is a mechanical bioabsorbable bone screw, not an AI/CADe system. Therefore, no MRMC study or AI assistance is relevant.

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

This information is not applicable as this is a mechanical bioabsorbable bone screw, not an AI/CADe system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's performance is established by objective mechanical measurements against recognized international standards (ASTM and ISO) for medical device performance (e.g., axial pullout strength, torsional yield strength, driving torque, degradation testing, fatigue).

8. The sample size for the training set

This information is not applicable as this is a mechanical device undergoing bench testing, not an AI/CADe system requiring a training set.

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

This information is not applicable as this is a mechanical device undergoing bench testing, not an AI/CADe system.

Summary

{0}------------------------------------------------

August 27, 2021

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 seal of the Department of Health & Human Services USA. To the right of the seal is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font below.

OSTEONIC Co., Ltd. % Sanglok Lee Manager WISE COMPANY Inc. #507, #508, 166 Gasan digital 2-ro Geumcheon-gu, Seoul 08507 South Korea

Re: K210122

Trade/Device Name: Sterile Bioabsorbable Bone Screw (Biocomposite ACL Screw) Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI Dated: July 20, 2021 Received: July 22, 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 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

{1}------------------------------------------------

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,

Laura C. Rose -S

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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K210122

Device Name

Sterile bioabsorbable bone screw (Biocomposite ACL screw)

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/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 dark gray on the right. The geometric shape is a diamond with a smaller diamond inside it.

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

K210122 - Page 1 of 5

The assigned 510(k) Number: K210122

1. 510(k) Summary Date: 15.01.2021

2. Applicant

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

3. Submission Correspondent

Sang-lok, 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

4. Subject Device Identification

1. Trade Name: Sterile bioabsorbable bone screw (Biocomposite ACL screw)
1. Common Name: Sterile bioabsorbable bone screw (Biocomposite ACL screw)
1. Classification Name: fastener, fixation, biodegradable, soft tissue
1. Product Code: MAI
1. Panel: Orthopedic
1. Regulation Number: 21 CFR 888.3030
1. Device Class: II

5. Indication for use

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image contains the logo for Osteonic. The logo consists of a blue geometric shape resembling a stylized diamond or square with an opening in the center, positioned to the left of the company name. The text "OSTEONIC" is written in a bold, dark gray sans-serif font to the right of the geometric shape.

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

K210122 - Page 2 of 5

6. Predicate devices

Predicate device

1. 510(k) Number: K143660
1. Device Name: Milagro/Milagro Advance Interference Screw
1. Manufacturer: DePuy Mitek, Inc.

Reference device

1. 510(k) Number: K103831
1. Device Name: Milagro Interference screw
1. Manufacturer: DePuy Mitek, Inc.

Reference device

1. 510(k) Number: K202806
1. Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi SelfPunching)

Manufacturer: Osteonic Co., Ltd.

7. Device Description

Sterile bioabsorbable bone screw (Biocomposite ACL screw) is supplied EO gas sterile state and it is packed in Aluminum 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 following standards were used to support substantial equivalence:

▪ Mechanical Performance

ASTM F2502:17 Standard Specification and test methods for absorbable plates and screws for internal fixation implants
ISO 13781:2017 Implants for surgery Homopolymers, copolymers and blends on poly(lactide) In vitro degradation testing
= 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

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the Osteonic logo. The logo consists of a blue geometric shape on the left and the word "OSTEONIC" in dark gray on the right. The geometric shape is a diamond with a stylized "O" inside, created by overlapping lines. The word "OSTEONIC" is in a bold, sans-serif font.

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

K210122 - Page 3 of 5

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

2) Summary of Biocompatibility

Sterile bioabsorbable bone screw (Biocomposite 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 test criteria established based on literatures and comparison with the predicate device. Therefore, the entire model was proven.

No.	Test Article	Test Method	Result
1	Axial Pullout Strength	Test referring ASTM F2502-A3.Test Method for AxialPullout of Absorbable Bone Screws.After fully inserting the screw into the artificial bone (20PCF),Apply tensile load to the specimen at a rate 5mm/min until thescrew fails or releases from the block. Measure the maximumload.	PASS
2	Torsional Yield Strength	Test referring ASTM F2502-A1.Test Method for Determiningthe Torsion Properties of Absorbable Bone Screws.After placing the specimen in the holding device, Rotate thescrew in inserting direction at a rate of 1 revolution/min.Torsional yield strength is determined by an off-set method (2degree off-set) on the torque versus rotation angle curvemeasured in the test.	PASS
3	Driving Torque	Test referring ASTM F2502-A2.Test Method for DrivingTorque of Absorbable Bone Screws.Make a hole in the fixed artificial bone (20PCF) using aninstrument compatible with the product. Measure themaximum strength when the screw is inserted 4 revolutions ata rate of 5 revolutions per minute.* Inserting load (axial load) = 1.14kgf	PASS
4	Degradation testing	Mechanical performance assessed after degradation accordingto ISO 13781	PASS
5	Fatigue	After fully inserting the screw with the tendon into the fixedartificial bone (20PCF), a fatigue tensile load of 70 to 220N	PASS

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for Osteonic. The logo consists of a blue diamond shape with a stylized "O" inside, followed by the word "OSTEONIC" in bold, dark blue letters. The logo is simple and modern, with a focus on the company name.

OSTEONIC Tel: +82(2)-6902-8400 Fax: +82(2)-6902-8401 Home page: http://www.osteonic.com

K210122 - Page 4 of 5

on the tendon is repeated 1000 cycles at 1 Hz.

9. Substantially Equivalent Conclusion

Table 1: Substantial Equivalence Comparison

ProductName	SUBJECT Device	PREDICATE DeviceMilagro/Milagro AdvanceInterference Screw (K143660)	REFERENCE Device 1Milagro Interference screw(K103831)	EquivalenceDiscussion
Productcode	MAI	MAI	MAI, HWC	Same
Regulatoryclass	Class II	Class II	Class II	Same
RegulationNumber	21 CFR 888.3030	21 CFR 888.3030	21 CFR 888.3040	Same
IntendedUse	Sterile bioabsorbable bonescrew (Biocomposite ACLscrew) is a fixation screw thatfixes soft tissue such asligaments, tendons, and thearticular capsules to bone, andis used in orthopedicsurgery(Cruciate ligamentreconstruction procedures).	Milagro Interferencescrew(5x12,6x12,7x15,8x15)The MILAGRO BRInterference screws aredesigned to attach soft tissuesto bone in Ortohpedic surgicalprocedures for the followingindications:Shoulder : Proximal BicepsTenodesis, Acromio-Clavicular RepairElbow: Distal BicepsTenodesis, Ulnar CollateralLigament RepairKnee: Collateral LigamentRepair, Medial PatellofemoralLigament Reconstruction(patella fixation)Milagro Advance Interferencescrew(7x23,8x23,9x23)The MILAGRO ADVANCEInterference screw is intendedfor attachment of soft tissuegrafts or bone-tendon-bonegrafts to the tibia and/or femerduring cruciate ligamentreconstruction procedures.Additionally, the 7, 8 and9mm x 23mm screws areindicated for : medial andlateral collateral ligamentrepair, medial patellofemoralligament reconstruction(femerfixation) of the knee, proximalbicep tenodesis in the shoulderand distal bicep tenodesis inthe elbow.	Knee :- Attachment of a bone-tendon-bone(BTB)graft to the tibiaand/or femur during cruciateligamentreconstructionprocedure.- Attachment of a soft tissue(ST)graft to the tibia and/orfemur during cruciate ligamentreconstruction procedures.- Medial and lateral collateralligament repairShoulder :Proximal bicep tenodesisElbow :Distal bicep tenodesis	Same
OperatingPrinciples	Sterile bioabsorbable bonescrew (Biocomposite ACLscrew) is a fixation screw thatfixes soft tissue such asligaments, tendons, and thearticular capsules to bone, and	Milagro/Milagro AdvanceInterference Screw is afixation screw that fixes softtissue such as ligaments,tendons, and the articularcapsules to bone, and is used	Milagro Interference screwis a fixation screw that fixessoft tissue such as ligaments,tendons, and the articularcapsules to bone, and is usedin orthopedic surgery(Cruciate	Same

	is used in orthopedicsurgery(Cruciate ligamentreconstruction procedures).	in orthopedic surgery(Cruciateligament reconstructionprocedures).	ligament reconstructionprocedures).
Material	PLGA + β-TCP	Composite of β-TCP andPLGA copolymer	Absorbable Poly(lactide -co-glycolide) polymer andTricalcium Phosphate(TCP)	Same
ProductSize	Ø7.0 x (25, 30) mmØ8.0 x (23, 25, 28, 30) mmØ9.0 x (23, 25, 28, 30) mmØ10.0 x (23, 25, 28, 30) mm	Ø5.0 x 12 mmØ6.0 x 12 mmØ7.0 x (15, 23) mmØ8.0 x (15, 23) mmØ9.0 x 23 mm	Ø5.0 x (23, 30) mmØ6.0 x (23, 30) mmØ7.0 x (23, 30) mmØ8.0 x (23, 30) mmØ9.0 x (23, 30, 35) mmØ10.0 x (23, 30, 35) mmØ11.0 x (30, 35) mmØ12.0 x (30, 35) mm	Similar
Sterilization	Sterile (EO gas sterilization)	Sterile (EO gas sterilization)	Sterile (EO gas sterilization)	Same
Single Use/Reuse	Single use	Single use	Single use	Same
Packaging	1 EA / BOX	1 EA / BOX	1 EA / BOX	Same

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for Osteonic. The logo consists of a blue geometric shape resembling a stylized diamond or square with internal lines, positioned to the left of the company name. The text "OSTEONIC" is written in a bold, dark gray sans-serif font.

1206Ho, 38, Digital-ro 29-gil, Guro-gu, Seoul, Korea Tel: +82(2)-6902-8400 Fax: +82(2)-6902-8401 Home page: http://www.osteonic.com

K210122 - Page 5 of 5

Based on above, the subject device, Sterile absorbable bone screw (Biocomposite ACL screw), is determined to be Substantially Equivalent (SE) to the predicate devices, Milagro Advance Interference Screw (K143660) in respect of safety and effectiveness.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.