Fixone Biocomposite Anchor

K171299 · Aju Pharm Co., Ltd. · MAI · Aug 24, 2017 · Orthopedic

Device Facts

• Record ID: K171299
• Device Name: Fixone Biocomposite Anchor
• Applicant: Aju Pharm Co., Ltd.
• Product Code: MAI · Orthopedic
• Decision Date: Aug 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotor 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; Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis; Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Device Story

Fixone Biocomposite Anchor is a manual orthopedic fixation device used to reattach soft tissue to bone. The system consists of a biodegradable anchor (PLGA copolymer and β-TCP) and a non-resorbable suture (cobraided UHMWPE and PET fibers) delivered via a dedicated driver. The device is used by surgeons in clinical settings (OR) to perform procedures such as rotator cuff repair, Bankart repair, and ligament reconstructions. The surgeon manually implants the anchor into the bone to secure the suture, which then holds the soft tissue in place. This mechanical fixation facilitates tissue healing. The device is provided non-sterile and requires autoclave sterilization by the user before use.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993 series: cytotoxicity, systemic toxicity, pyrogenicity, sensitization, genotoxicity, implantation), mechanical testing (fixation strength per ASTM F2502), and chemical characterization (EO residues, heavy metals, pH, UV spectrum). All tests passed, demonstrating performance equivalent to predicate devices.

Technological Characteristics

Materials: PLGA (70%) and β-TCP (30%) anchor; UHMWPE/PET suture. Principle: Manual screw-in bone fixation. Dimensions: 4.5mm to 6.5mm diameters. Sterilization: User-performed autoclave (134°C/20 min). Standards: ASTM F2502, ISO 10993, ISO 11135.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot/ankle, knee, and elbow orthopedic procedures, including ligament and tendon 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

• Bio-Corkscrew Suture Anchor (K043337)
• PushLock Anchors (K101679)
• Healix BR Anchor (K073412)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

AJU Pharm Co., Ltd. % Mr. Peter Chung President Plus Global 300 Atwood Street Pittsburgh, Pennsylvania 15213

August 24, 2017

Re: K171299

Trade/Device Name: Fixone Biocomposite Anchor 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 10, 2017 Received: July 17, 2017

Dear Mr. Chung:

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. 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

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K171299

Device Name Fixone Biocomposite Anchor

The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:

Shoulder: Rotor Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, lliotibial Band Tenodesis;

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

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) Summary

### [as required by 807.92(c)]

#### 1. Applicant

- Company : AJU Pharm Co.,Ltd. 1)
- 2) Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
- 3) Tel : [phone]
- Fax : [phone])
- 5) Prepared date : Jul. 4, 2016
- 6) Contact person : Peter Chung, 412-512-8802
- 7) Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
- 8) Submission date : Jul. 11, 2016

#### 2. Device Information

- Trade name : Fixone Biocomposite Anchor 1)
- 2) Common name : Biodegradable Orthopedic Bone Screw
- Regulation name : Fastener, Screw, Fixation, Bone, Suture 3)
- 4) Product code : MAI
- Regulation number : 888.3030 5)
- ୧) Class of device : Class II
- 7) Panel : Orthopedic

#### 3. The legally marketed device to which we are claiming equivalence

K043337, Arthrex, Inc. Bio-Corkscrew Suture Anchor K101679, Arthrex, Inc. PushLock Anchors K073412, Depuy Mitek, Healix BR Anchor

#### 4. Device description

The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-ΤCP). A nonresorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver.

This device is could used with instrument that manufactured by Aju Pharm Co.,Ltd. It is consist of 18 models. It provide non-sterile (user must sterilization before use).

| Product name | Instrument / 18 model codes including Fixone.I.B-A/T450a |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model name | Fixone.I.B-A/T450a, Fixone.I.B-A/T475a, Fixone.I.B-A/T500a, Fixone.I.B-A/T525a, Fixone.I.B-A/T550a, Fixone.I.B-A/T575a, Fixone.I.B-A/T600a, Fixone.I.B-A/T625a, Fixone.I.B-A/T650a, Fixone.I.B-Awl450a, Fixone.I.B-Awl475a, Fixone.I.B-Awl500a, Fixone.I.B-Awl525a, Fixone.I.B-Awl550a, Fixone.I.B-Awl575a, Fixone.I.B-Awl600a, Fixone.I.B-Awl625a, Fixone.I.B-Awl650a |
| Intended use | The instrument of make the hole in the bone. |
| Manufacturer | Ajumedical / Korea |
| Sterilization | Non-sterile |
| Sterilization method | Autoclave / 134°C/ 20 min |

#### 5. Intended Use :

#### The Fixone Biocomposite Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures:

Shoulder: Rotor 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;

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

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

#### 6. Performance data:

- Bench test were performed. Bench testing included biocompatibility, mechanical testing 1) including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device. The following bench testing is performed to demonstrate the functionality is substantially equivalent.

| Test item | Requirements | Results |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| External surface | | |
| Measurement | | |
| Insertion torque | | |
| Fixation strength | ASTM F2502 and USP<28> | Pass |
| Tensile strength | | |
| Extractable color | | |
| Extraction test | | |
| pH | The difference should be 1.5 and less. | |
| Potassium permanganate<br>reducing substances | The difference of the consumption of potassium permanganate<br>should be 2.0 mL and less. | |
| Residue after evaporation | Record the weight of the residue should be 1.0mg and less. | |
| Heavy metals | Any brown color produced within 10 minutes in the tube containing<br>the extract of the prepared sample does not exceed that in the tube<br>containing the standard lead solution | Pass |
| UV spectrum(250nm~350nm) | Maximum absorbance between 250 to 350 nm should be 0.1 and less. | |
| Property | When observing it with the naked eye, test solution should be clear<br>and have no forign particles. | |

#### 2) Biocompatibility

#### Anchor

| # | Test item | Test method / Test criteria | Test result |
|----|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------|
| 1 | Cytotoxicity | ISO 10993-5(2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| 2 | Acute systemic toxicity test | ISO 10993-11(2009) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| 3 | Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| 4 | Intracutaneous(intradermal) reactivity test | ISO 10993-10(2013) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| 5 | Maximization test for delayed hypersensicivity | ISO 10993-10(2013) Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| 6 | Bacterial revers mutation test | ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
| 7 | Mammalian erythrocyte micronucleus test | ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
| 8 | Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| 9 | Bioabsorbable screws test | ASTM F2502 Standard specification and test methods for bioabsorbable plates and screws for internal fixation implants | Pass |
| 10 | Subchronic toxicity test | ISO 10993-11 Biological Evaluation of Medical Devices Part 11- Test for systemic toxicity | Pass |

#### Suture

| # | Test item | Test method / Test criteria | Test result |
|---|---------------------------|----------------------------------------------------------------------------------------------------|-------------|
| 1 | Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in<br>vitro cytotoxicity | Pass |
| 2 | Systemic toxicity<br>test | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for<br>systemic toxicity | Pass |

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| ന | Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | | |
|---|-------------------|------------------------------------------------------------------------------|------|--|
| प | Intracutaneous | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for | Pass | |
| | reactivity test | irritation and skin sensitization | | |
| 5 | Maximization | ISO 10993-10, Test for irritation and skin sensitization, Maximization test | Pass | |
| | sensitization | for delayed hypersensitivity | | |
| 6 | Genotoxicity test | ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | | |
| 8 | Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test | Pass | |
| | | methods for implantation in bone | | |
| g | Hemolysis test | ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of | Pass | |
| | | tests for interactions with blood | | |

The performance tests demonstrated that Fixone Biocomposite Anchor performs in a substantially equivalent manner to the predicate device.

#### 7. Predicate device comparison table

#### 1) B-type and K-type

| Manufacturer | AJU Pharm Co.,Ltd. | Depuy Mitek | Remark |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510(k) No. | K171299 | K073412 | N/A |
| Indication for use | The Fixone Biocomposite Anchors are<br>intended for fixation of suture (soft<br>tissue) to bone in the shoulder,<br>foot/ankle, knee and elbow in the<br>following procedures:<br><b>Shoulder</b> : Rotor Cuff Repair, Bankart<br>Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation<br>Repair, Deltoid Repair, Capsular Shift or<br>Capsulolabral Reconstruction;<br><b>Foot/Ankle</b> : Lateral Stabilization, Medial<br>Stabilization, Achilles Tendon Repair;<br><b>Knee</b> : Medial Collateral Ligament Repair,<br>Lateral Collateral Ligament Repair,<br>Posterior Oblique Ligament Repair,<br>Iliotibial Band Tenodesis;<br><b>Elbow</b> : Biceps Tendon Reattachment,<br>Ulnar or Radial Collateral Ligament<br>Reconstruction. | <b>Shoulder</b> : Rotor Cuff Repair, Bankart<br>Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation<br>Repair, Deltoid Repair, Capsular Shift or<br>Capsulolabral Reconstruction;<br><b>Foot/Ankle</b> : Lateral Stabilization, Medial<br>Stabilization, Achilles Tendon Repair;<br><b>Knee</b> : Medial Collateral Ligament Repair,<br>Lateral Collateral Ligament Repair,<br>Posterior Oblique Ligament Repair,<br>Iliotibial Band Tenodesis;<br><b>Elbow</b> : Biceps Tendon Reattachment,<br>Ulnar or Radial Collateral Ligament<br>Reconstruction. | Same |
| Classification name | Fastener, Screw, Fixation, Bone, Suture | Fastener, Screw, Fixation, Bone, Suture | Same |
| Trade name | Fixone Biocomposite Anchor | Healix BR Anchor | N/A |
| Model/type | 80 model codes including BAB-45001a | 5 model codes including 4.5 Healix BR<br>Anchor | N/A |
| Appearance | Image: Two white, screw-like anchors | Image: Three white, screw-like anchors with drivers | Similar |
| Product<br>configuration | Driver<br>Anchor<br>Suture | Driver<br>Anchor<br>Suture | Same |
| Material | PLGA(70%) + β-TCP(30%) | PLGA(70%) + β-TCP(30%) | Same |
| Anchor | | | |
| Outside diameter | 4.5mm/4.75mm/5.5mm/5.75mm/6.5mm | 4.5mm/5.5mm/6.5mm | Similar |
| Length of abchor | 14.6mm/15mm/15.7mm/16mm/16.8mm | Not known | N/A |
| Suture | | | |
| Absorbable | Non-absorbable | Non-absorbable | Same |
| Suture diameter | 0.50~0.599 (USP size 2) | 0.50~0.599 (USP size 2) | Same |

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| Manufacturer | AJU Pharm Co.,Ltd. | Depuy Mitek | Remark |
|---------------------------|------------------------------------------------------|------------------------------------------------------|--------|
| Material | Polyethylene | Polyethylene | Same |
| Sterilization | EO Gas sterilization<br>According to ISO 11135: 2007 | EO Gas sterilization<br>According to ISO 11135: 2007 | Same |
| Biodegradable | Yes | Yes | Same |
| Principle of<br>operation | Manual | Manual | Same |
| Shelf-life | 5 years | N/A | N/A |

| Manufacturer | AJU Pharm Co.,Ltd. | Arthrex, Inc. | Remark |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 510(k) No. | K171299 | K043337 | N/A |
| Indication for use | The Fixone Biocomposite Anchors are<br>intended for fixation of suture (soft<br>tissue) to bone in the shoulder,<br>foot/ankle, knee and elbow in the<br>following procedures:<br>Shoulder: Rotor Cuff Repair, Bankart<br>Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation<br>Repair, Deltoid Repair, Capsular Shift or<br>Capsulolabral Reconstruction;<br>Foot/Ankle: Lateral Stabilization, Medial<br>Stabilization, Achilles Tendon Repair;<br>Knee: Medial Collateral Ligament Repair,<br>Lateral Collateral Ligament Repair,<br>Posterior Oblique Ligament Repair,<br>Iliotibial Band Tenodesis;<br>Elbow: Biceps Tendon Reattachment,<br>Ulnar or Radial Collateral Ligament<br>Reconstruction. | The Arthrex Bio-Corkscrew Suture Anchor<br>is intended for fixation of suture to bone<br>in the shoulder, foot/ankle, knee,<br>hand/wrist, elbow, and pelvis. | Similar |
| Classification name | Fastener, Screw, Fixation, Bone, Suture | Fastener, Screw, Fixation, Bone, Suture | Same |
| Trade name | Fixone Biocomposite Anchor | Bio-Corkscrew Suture Anchor | N/A |
| Model/type | 80 model codes including BAB-45001a | N/A | N/A |
| Appearance | | | Similar |
| Product<br>configuration | Driver<br>Anchor<br>Suture | Driver<br>Anchor<br>Suture | Same |
| Material | PLGA + β-TCP | PLLA + B-TRICALCIUM PHOSPHATE | Similar |
| Anchor | | | |
| Outside diameter | 4.5mm/4.75mm/5.5mm/5.75mm/6.5mm | 4.5mm/4.75mm/5.5mm/5.75mm/6.5mm | Same |
| Length of abchor | 14.6mm/15mm/15.7mm/16mm/16.8mm | 15mm/16mm | Similar |
| Suture | | | |
| Absorbable | Non-absorbable | Non-absorbable | Same |
| Suture diameter | 0.50~0.599 (USP size 2) | 0.50~0.599 (USP size 2) | Same |
| Material | Polyethylene | Polyethylene | Same |
| Sterilization | EO Gas sterilization<br>According to ISO 11135: 2007 | EO Gas sterilization<br>According to ISO 11135: 2007 | Same |
| Biodegradable | Yes | Yes | Same |
| Principle of<br>operation | Manual | Manual | Same |
| Shelf-life | 5 years | N/A | N/A |

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#### 2) KC-type

| Manufacturer | AJU Pharm Co.,Ltd. | Arthrex, Inc. | Remark |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----------|
| 510(k) No. | K171299 | K101679 | N/A |
| Indication for use | The Fixone Biocomposite Anchors are<br>intended for fixation of suture (soft<br>tissue) to bone in the shoulder,<br>foot/ankle, knee and elbow in the<br>following procedures:<br><b>Shoulder</b> : Rotor Cuff Repair, Bankart<br>Repair, SLAP Lesion Repair, Biceps<br>Tenodesis, Acromio-Clavicular Separation<br>Repair, Deltoid Repair, Capsular Shift or<br>Capsulolabral Reconstruction;<br><b>Foot/Ankle</b> : Lateral Stabilization, Medial<br>Stabilization, Achilles Tendon Repair;<br><b>Knee</b> : Medial Collateral Ligament Repair,<br>Lateral Collateral Ligament Repair,<br>Posterior Oblique Ligament Repair,<br>Iliotibial Band Tenodesis;<br><b>Elbow</b> : Biceps Tendon Reattachment,<br>Ulnar or Radial Collateral Ligament<br>Reconstruction. | Intended to be used for sutures or tissue<br>fixation in the foot, ankle, knee, hand,<br>wrist, elbow, shoulder, hip | Similar |
| Classification name | Fastener, Screw, Fixation, Bone, Suture | Fastener, Screw, Fixation, Bone, Suture | Same |
| Trade name | Fixone Biocomposite Anchor | Arthrex PushLock Anchors | N/A |
| Model/type | 80 model codes including BAB-45001a | N/A | N/A |
| Appearance | Image: Fixone Biocomposite Anchor | Image: Arthrex PushLock Anchors | Similar |
| Product<br>configuration | Driver | Driver | Same |
| | Anchor | Anchor | Same |
| | Suture | Suture | Same |
| | Clip | | Different |
| Material | PLGA + $β$ -TCP | PLLA + B-TRICALCIUM PHOSPHATE | Similar |
| Outside diameter | 4.5mm/4.75mm/5.5mm/5.75mm<br>6.0mm/6.5mm | 3.5mm/4.5mm/4.75mm/5.5mm | Similar |
| Length of anchor | 16.7mm/17.2mm/17.7mm | 15.0mm/19.1mm/19.5mm/20.0mm<br>24.0mm/24.5mm/28.0mm | Similar |
| Sterilization | EO Gas sterilization<br>According to ISO 11135: 2007 | EO Gas sterilization<br>According to ISO 11135: 2007 | Same |
| Biodegradable | Yes | Yes | Same |
| Principle of<br>operation | Manual | Manual | Same |
| Shelf-life | 5 years | N/A | N/A |

#### 9. Conclusion

The device is investigated for function to compare the operation of function between Fixone Biocomposite Anchor and predicate devices.

Comparison results demonstrate that the specifications and performance of the device are substantially equivalent to the legally marketed predicate device.

Therefore, it is concluded that Fixone Biocomposite Anchor is substantially equivalent to the legally marketed predicate device.