Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

K202806 · Osteonic Co., Ltd. · MAI · Jun 17, 2021 · Orthopedic

Device Facts

• Record ID: K202806
• Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)
• Applicant: Osteonic Co., Ltd.
• Product Code: MAI · Orthopedic
• Decision Date: Jun 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow. Shoulder: Rotator Cuff Repair, Bankart Repair, Siceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers. Mid-foot reconstruction Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Device Story

Fix2Lock is an absorbable bone fixation screw system used in orthopedic surgery to secure soft tissues (ligaments, tendons, articular capsules) to bone. The device consists of an absorbable/non-absorbable anchor, non-absorbable suture, driver shaft, and handle. It is used by orthopedic surgeons in clinical settings (OR). The surgeon inserts the anchor into the bone to provide mechanical fixation of soft tissue via the attached suture. This facilitates healing by maintaining tissue position. The device is single-use and sterile.

Clinical Evidence

Bench testing only. Testing verified design specifications and compliance with ASTM F2026 (PEEK), ASTM F2848 (UHMWPE), ASTM F543 (mechanical performance), and various ISO/USP standards for sterilization, packaging, and bacterial endotoxins.

Technological Characteristics

Materials: PLGA + β-TCP (anchor), PEEK (Biocombi self-punching anchor), UHMWPE (suture). Standards: ASTM F2026, F2848, F543. Dimensions: 2.6–6.5 mm diameter, 10.0–20.8 mm length. Sterilization: Ethylene Oxide (EtO). Single-use, sterile, 5-year shelf life.

Indications for Use

Indicated for soft tissue-to-bone fixation using suture in shoulder, foot/ankle, knee, hand/wrist, and elbow orthopedic procedures, including ligament, tendon, and articular capsule repairs.

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

• Fixone Biocomposite Small anchor (K192032)

Reference Devices

• Fixone Biocomposite anchor (K192484)
• Force Fiber ® Suture (K181774)
• Force Fiber Fusion™ Suture (K172016)

Submission Summary (Full Text)

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June 17, 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 Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K202806

Trade/Device Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Regulation Number: 21 CFR 888.3030 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MAI, MBI Dated: September 22, 2020 Received: September 23, 2020

Dear Sandlok 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

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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 (OS) 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 ([e-mail]) or phone [phone] 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) K202806

#### Device Name

Fix2Lock(Biocomposite medial, Biocomposite lateral, Biocombi Self Punching)

Indications for Use (Describe)

The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.

Shoulder: Rotator Cuff Repair, Bankart Repair, Siceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers. Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

| 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/2 description: The image contains a logo with a geometric shape on the left and text on the right. The geometric shape is a blue diamond with lines inside. To the right of the shape, the word "OSTEONIC" is written in bold, dark blue letters. Below "OSTEONIC", the phrase "The Medical Explorer" is written in a smaller, lighter font.

# The assigned 510(k) Number: K202806

# 01. Date of Submission: 2020.09.17

# 02. Applicant

Dakyung Ham OSTEONIC Co., Ltd. 303Ho, 405Ho, 505-2Ho, 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: [phone] FAX: [phone] Email: [e-mail]

# 03. Submission Correspondent

Sanglok, Lee Wise COMPANY Inc. #303, 142, Gasan digital 1-ro, Geumcheon-gu, Seoul, Korea TEL: [phone] FAX: [phone] Email: [e-mail]

# 04. Subject Device Identification

Trade Name: Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) Common Name: Bioabsorbable bone anchor Classification Name: fastener, fixation, non-biodegradable, soft tissue Classification Product Code: MAI Subsequent Product Code: MBI Panel: Orthopedic Regulation Number: 21 CFR 888.3030 Device Class: II

#### 05. Indication for use

The Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; shoulder, foot/ankle, knee, hand/wrist and elbow.

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, digital tendon transfers

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

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K202806 Page 2 of 4

Image /page/4/Picture/1 description: The image contains a logo for a company called 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 font, and below it, in a smaller, lighter font, is the tagline "The Medical Explorer".

# 06. Predicate devices

Predicate device 510(k) Number: K192032 Device Name: Fixone Biocomposite Small anchor Manufacturer: AJU Pharm Co., Ltd.

Reference device 510(k) Number: K192484 Device Name: Fixone Biocomposite anchor Manufacturer: AJU Pharm Co., Ltd.

510(k) Number: K181774 Device Name: Force Fiber ® Suture Manufacturer: Teleflex Medical Incorporated

510(k) Number: K172016 Device Name: Force Fiber Fusion™ Suture Manufacturer: Teleflex Medical Incorporated

# 07. Device Description

The Fix2Lock (Bioabsorbable bone anchor) 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.

This product consists of an absorbable and/or non-absorbable suture and driver shaft and handle.

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Image /page/5/Picture/1 description: The image shows the logo for Osteonic, a medical explorer company. The logo features 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 bold, dark font, and below it, in smaller, lighter font, is the tagline "The Medical Explorer."

### 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 surgications
- ASTM F2848: 2017 Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns
- 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

# 09. Substantially Equivalent Conclusion

#### Table 1: Substantial Equivalence Comparison

| Product<br>Name | SUBJECT Device | PREDICATE Device<br>Fixone<br>Biocomposite<br>Small<br>anchor (K192032) | REFERENCE Device 1<br>Fixone<br>Biocomposite<br>anchor<br>(K192484) | Equivalence<br>Discussion |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Product<br>code | MAI | MAI, MBI | MAI | Same |
| Regulatory<br>class | Class II | Class II | Class II | Same |
| Regulation<br>Number | 21 CFR 888.3030 | 21 CFR 888.3030 | 21 CFR 888.3030 | Same |
| Intended use | The Fix2Lock is intended use for<br>fixation of soft tissue to bone,<br>using suture, in the following<br>procedure:<br>shoulder, foot/ankle, knee,<br>hand/wrist and elbow.<br>Shoulder: Rotator Cuff Repair.<br>Bankart Repair, SLAP Lesion<br>Repair, Biceps Tenodesis,<br>Acromio-Clavicular Separation<br>Repair, Deltoid Repair, Capsular<br>Shift or Capsulolabral | The Fixone Biocomposite Small<br>Anchor are intended to be used<br>for suture (soft tissue) fixation to<br>bone in the foot, ankle, knee,<br>hand, wrist, elbow, shoulder, and<br>hip.<br>Shoulder: Rotator Cuff Repair,<br>Bankart Repair, SLAP Lesion<br>Repair, Biceps Tenodesis,<br>Acromio-Clavicular Separation<br>Repair, Deltoid Repair, Capsular<br>Shift or Capsulolabral | The Fixone Biocomposite<br>Anchors are intended for fixation<br>of suture (soft<br>tissue) to bone in the shoulder,<br>foot/ankle, knee and elbow in the<br>following procedures:<br>Shoulder: Rotator Cuff Repair,<br>Bankart<br>Repair, SLAP Lesion Repair,<br>Biceps<br>Tenodesis, Acromio-Clavicular<br>Separation | Similar |
| | Reconstruction<br>Foot/Ankle: Lateral Stabilization,<br>Medial Stabilization, Achilles<br>Tendon Repair, Metatarsal<br>Ligament Repair, Hallux Valgus<br>reconstruction, digital tendon<br>transfers, Mid-foot reconstruction<br>Knee: Medial Collateral Ligament<br>Repair, Lateral Collateral<br>Ligament Repair, Patellar Tendon<br>Repair, Posterior Oblique<br>Ligament Repair, Iliotibial Band<br>Tenodesis<br>Hand/Wrist: Scapholunate<br>Ligament Reconstruction, Carpal<br>Ligament Reconstruction,<br>Repair/Reconstruction of<br>collateral ligaments, Repair of<br>Flexor and Extensor Tendons at<br>the PIP, DIP, and MCP joints for<br>all digits, digital tendon transfers<br>Elbow: Biceps Tendon<br>Reattachment, Ulnar or Radial<br>Collateral Ligament<br>Reconstruction | Reconstruction Foot/Ankle:<br>Lateral Stabilization, Medial<br>Stabilization, Achilles Tendon<br>Repair, Metatarsal Ligament<br>Repair, Hallux Valgus<br>reconstruction, digital tendon<br>transfers, Midfoot reconstruction<br>Knee: Medial Collateral Ligament<br>Repair, Lateral Collateral<br>Ligament Repair, Patellar Tendon<br>Repair, Posterior Oblique<br>Ligament Repair, Iliotibial Band<br>Tenodesis<br>Hand/Wrist: Scapholunate<br>Ligament Reconstruction, Carpal<br>Ligament Reconstruction,<br>Repair/Reconstruction of<br>collateral ligaments, Repair of<br>Flexor and Extensor Tendons at<br>the PIP, DIP, and MCP joints for<br>all digits, digital tendon transfers<br>Elbow: Biceps Tendon<br>Reattachment, Ulnar or Radial<br>Collateral Ligament<br>Reconstruction<br>Hip: Capsular repair, Acetabular<br>Labral repair | Repair, Deltoid Repair, Capsular<br>Shift or<br>Capsulolabral Reconstruction;<br>Foot/Ankle: Lateral Stabilization,<br>Medial<br>Stabilization, Achilles Tendon<br>Repair;<br>Knee: Medial Collateral Ligament<br>Repair,<br>Lateral Collateral Ligament<br>Repair,<br>Posterior Oblique Ligament<br>Repair,<br>Iliotibial Band Tenodesis;<br>Elbow: Biceps Tendon<br>Reattachment,<br>Ulnar or Radial Collateral<br>Ligament<br>Reconstruction. | |
| Operating<br>Principles | Bone fixation screw that ties soft<br>tissues such as ligament, tendon,<br>and the articular capsules to bone. | Bone fixation screw that ties soft<br>tissues such as ligament, tendon,<br>and the articular capsules to bone. | Bone fixation screw that ties soft<br>tissues such as ligament, tendon,<br>and the articular capsules to bone. | Same |
| Material | Anchor:<br>-Biocomposite medial, lateral:<br>PLGA+ $\beta$ -TCP<br>-Biocombi self punching:<br>PLGA+ $\beta$ -TCP, PEEK<br>Suture: UHMWPE | Anchor:<br>PLGA+ $\beta$ -TCP<br>Suture: UHMWPE | Anchor:<br>PLGA+ $\beta$ -TCP<br>Suture: UHMWPE | Similar |
| Structure | This product consists of an<br>absorbable and/or non-absorbable<br>anchor, a non-absorbable suture<br>and driver shaft and handle. | This product consists of an<br>absorbable anchor, a non-<br>absorbable suture and driver shaft<br>and handle. | This product consists of an<br>absorbable anchor, a non-<br>absorbable suture and driver shaft<br>and handle. | Similar |
| Product<br>Size | Anchor diameter: Ø 2.6 to 6.5 mm<br>Anchor length: 10.0 to 20.8mm | Anchor diameter: Ø 3.0mm<br>Anchor length: 11.9mm | Anchor diameter: Ø 3.0 to 6.5 mm<br>Anchor length: 11.9 to 16.8mm | Similar |
| Sterilization | Sterile (EtO sterilization) | Sterile (EtO sterilization) | Sterile (EtO sterilization) | Same |
| Single Use/<br>Reuse | Single use | Single use | Single use | Same |
| Packaging | 1 EA / BOX | 1 EA / BOX | 1 EA / BOX | Same |
| Shelf -life | 5Years | 5Years | 5Years | Same |

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Image /page/6/Picture/1 description: The image contains a logo with a blue geometric shape on the left and the word "OSTEONIC" in bold, dark gray letters on the right. Below "OSTEONIC" is the phrase "The Medical Explorer" in a smaller, lighter gray font. The geometric shape appears to be a stylized representation of a bone structure or a medical symbol.

Based on above, the subject device, Fix2Lock (Biocomposite lateral, Biocombi Self Punching), is determined to be Substantially Equivalent (SE) to the predicate devices, Fixone Biocomposite Small anchor (K192032) in respect of safety and effectiveness.