Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)

K210122 · Osteonic Co., Ltd. · MAI · Aug 27, 2021 · Orthopedic

Device Facts

• Record ID: K210122
• Device Name: Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw)
• Applicant: Osteonic Co., Ltd.
• Product Code: MAI · Orthopedic
• Decision Date: Aug 27, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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 Story

Sterile bioabsorbable bone screw (Biocomposite ACL screw) is an implantable device used in orthopedic surgery to fix soft tissues (ligaments, tendons, articular capsules) to bone during cruciate ligament reconstruction. The screw is composed of poly(L-lactide-co-glycolide) (PLGA) and tri-calcium phosphate (β-TCP). It is designed to be gradually decomposed in vivo via hydrolysis, with PLGA excreted as carbon dioxide and water, and β-TCP re-used as a calcium source. The device is supplied sterile via ethylene oxide gas in an aluminum pouch for single-use application by orthopedic surgeons. It provides mechanical fixation of grafts to bone, facilitating healing and reconstruction.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including axial pullout strength, torsional yield strength, driving torque, degradation testing per ISO 13781, and fatigue testing (1000 cycles at 1 Hz). Biocompatibility evaluated per ISO 10993.

Technological Characteristics

Material: Poly(L-lactide-co-glycolide) (PLGA) and tri-calcium phosphate (β-TCP). Form factor: Bone screw. Sterilization: Ethylene oxide (EO) gas. Standards: ASTM F2502 (mechanical), ISO 13781 (degradation), ISO 10993 (biocompatibility), ISO 11135/11138/11140/11737/11607 (sterilization/packaging).

Indications for Use

Indicated for fixation of soft tissue (ligaments, tendons, articular capsules) to bone in orthopedic surgery, specifically cruciate ligament reconstruction procedures.

Regulatory Classification

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.

Predicate Devices

• Milagro/Milagro Advance Interference Screw (K143660)

Reference Devices

• Milagro Interference screw (K103831)
• Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi SelfPunching) (K202806)

Submission Summary (Full Text)

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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

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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 [phone] 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

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# Indications for Use

510(k) Number (if known) K210122

Device Name

Sterile bioabsorbable bone screw (Biocomposite ACL screw)

Indications for Use (Describe)

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).

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 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: [phone] Fax: [phone] 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: [phone] FAX: [phone] Email: [e-mail]

# 3. Submission Correspondent

Sang-lok, Lee Wise COMPANY Inc. #507, #508, 166 Gasan digital 2-ro, Geumcheon-gu, Seoul, Korea TEL: [phone] FAX: [phone] Email: [e-mail]

# 4. Subject Device Identification

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

# 5. Indication for use

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).

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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: [phone] Fax: [phone] Home page: http://www.osteonic.com

## K210122 - Page 2 of 5

## 6. Predicate devices

Predicate device

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

Reference device

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

Reference device

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

3) Manufacturer: Osteonic Co., Ltd.

# 7. 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.

# 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

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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: [phone] Fax: [phone] 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 Axial<br>Pullout of Absorbable Bone Screws.<br>After fully inserting the screw into the artificial bone (20PCF),<br>Apply tensile load to the specimen at a rate 5mm/min until the<br>screw fails or releases from the block. Measure the maximum<br>load. | PASS |
| 2 | Torsional Yield Strength | Test referring ASTM F2502-A1.Test Method for Determining<br>the Torsion Properties of Absorbable Bone Screws.<br>After placing the specimen in the holding device, Rotate the<br>screw in inserting direction at a rate of 1 revolution/min.<br>Torsional yield strength is determined by an off-set method (2<br>degree off-set) on the torque versus rotation angle curve<br>measured in the test. | PASS |
| 3 | Driving Torque | Test referring ASTM F2502-A2.Test Method for Driving<br>Torque of Absorbable Bone Screws.<br>Make a hole in the fixed artificial bone (20PCF) using an<br>instrument compatible with the product. Measure the<br>maximum strength when the screw is inserted 4 revolutions at<br>a rate of 5 revolutions per minute.<br>* Inserting load (axial load) = 1.14kgf | PASS |
| 4 | Degradation testing | Mechanical performance assessed after degradation according<br>to ISO 13781 | PASS |
| 5 | Fatigue | After fully inserting the screw with the tendon into the fixed<br>artificial bone (20PCF), a fatigue tensile load of 70 to 220N | PASS |

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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: [phone] Fax: [phone] 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

| Product<br>Name | SUBJECT Device | PREDICATE Device<br>Milagro/Milagro Advance<br>Interference Screw (K143660) | REFERENCE Device 1<br>Milagro Interference screw<br>(K103831) | Equivalence<br>Discussion |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Product<br>code | MAI | MAI | MAI, HWC | Same |
| Regulatory<br>class | Class II | Class II | Class II | Same |
| Regulation<br>Number | 21 CFR 888.3030 | 21 CFR 888.3030 | 21 CFR 888.3040 | Same |
| Intended<br>Use | Sterile bioabsorbable bone<br>screw (Biocomposite ACL<br>screw) is a fixation screw that<br>fixes soft tissue such as<br>ligaments, tendons, and the<br>articular capsules to bone, and<br>is used in orthopedic<br>surgery(Cruciate ligament<br>reconstruction procedures). | Milagro Interference<br>screw(5x12,6x12,7x15,8x15)<br>The MILAGRO BR<br>Interference screws are<br>designed to attach soft tissues<br>to bone in Ortohpedic surgical<br>procedures for the following<br>indications:<br>Shoulder : Proximal Biceps<br>Tenodesis, Acromio-<br>Clavicular Repair<br>Elbow: Distal Biceps<br>Tenodesis, Ulnar Collateral<br>Ligament Repair<br>Knee: Collateral Ligament<br>Repair, Medial Patellofemoral<br>Ligament Reconstruction<br>(patella fixation)<br>Milagro Advance Interference<br>screw(7x23,8x23,9x23)<br>The MILAGRO ADVANCE<br>Interference screw is intended<br>for attachment of soft tissue<br>grafts or bone-tendon-bone<br>grafts to the tibia and/or femer<br>during cruciate ligament<br>reconstruction procedures.<br>Additionally, the 7, 8 and<br>9mm x 23mm screws are<br>indicated for : medial and<br>lateral collateral ligament<br>repair, medial patellofemoral<br>ligament reconstruction(femer<br>fixation) of the knee, proximal<br>bicep tenodesis in the shoulder<br>and distal bicep tenodesis in<br>the elbow. | Knee :<br>- Attachment of a bone-tendon-<br>bone(BTB)graft to the tibia<br>and/or femur during cruciate<br>ligament<br>reconstruction<br>procedure.<br>- Attachment of a soft tissue<br>(ST)graft to the tibia and/or<br>femur during cruciate ligament<br>reconstruction procedures.<br>- Medial and lateral collateral<br>ligament repair<br>Shoulder :<br>Proximal bicep tenodesis<br>Elbow :<br>Distal bicep tenodesis | Same |
| Operating<br>Principles | Sterile bioabsorbable bone<br>screw (Biocomposite ACL<br>screw) is a fixation screw that<br>fixes soft tissue such as<br>ligaments, tendons, and the<br>articular capsules to bone, and | Milagro/Milagro Advance<br>Interference Screw is a<br>fixation screw that fixes soft<br>tissue such as ligaments,<br>tendons, and the articular<br>capsules to bone, and is used | Milagro Interference screw<br>is a fixation screw that fixes<br>soft tissue such as ligaments,<br>tendons, and the articular<br>capsules to bone, and is used<br>in orthopedic surgery(Cruciate | Same |
| | | | | |
| | is used in orthopedic<br>surgery(Cruciate ligament<br>reconstruction procedures). | in orthopedic surgery(Cruciate<br>ligament reconstruction<br>procedures). | ligament reconstruction<br>procedures). | |
| Material | PLGA + β-TCP | Composite of β-TCP and<br>PLGA copolymer | Absorbable Poly(lactide -co-<br>glycolide) polymer and<br>Tricalcium Phosphate(TCP) | Same |
| Product<br>Size | Ø7.0 x (25, 30) mm<br>Ø8.0 x (23, 25, 28, 30) mm<br>Ø9.0 x (23, 25, 28, 30) mm<br>Ø10.0 x (23, 25, 28, 30) mm | Ø5.0 x 12 mm<br>Ø6.0 x 12 mm<br>Ø7.0 x (15, 23) mm<br>Ø8.0 x (15, 23) mm<br>Ø9.0 x 23 mm | Ø5.0 x (23, 30) mm<br>Ø6.0 x (23, 30) mm<br>Ø7.0 x (23, 30) mm<br>Ø8.0 x (23, 30) mm<br>Ø9.0 x (23, 30, 35) mm<br>Ø10.0 x (23, 30, 35) mm<br>Ø11.0 x (30, 35) mm<br>Ø12.0 x (30, 35) mm | Similar |
| Sterilization | Sterile (EO gas sterilization) | Sterile (EO gas sterilization) | Sterile (EO gas sterilization) | Same |
| Single Use/<br>Reuse | Single use | Single use | Single use | Same |
| Packaging | 1 EA / BOX | 1 EA / BOX | 1 EA / BOX | Same |

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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: [phone] Fax: [phone] 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.