(113 days)
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.
The Fixone Biocomposite Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP). 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).
The document provided describes the Fixone Biocomposite Anchor, a medical device intended for fixation of suture (soft tissue) to bone. The information primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a novel study evaluating the device's performance against specific acceptance criteria in a clinical setting.
Therefore, many of the requested categories for AI/diagnostic device studies (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of submission.
The "acceptance criteria" in this context refer to the successful completion of a series of bench tests and biocompatibility tests to ensure the device meets established safety and performance standards for similar orthopedic implants, and demonstrates substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists various tests performed and their results. The "Requirements" column implicitly serves as the acceptance criteria for each test, with the "Results" column indicating "Pass" for all listed tests.
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Bench Tests | ||
| Fixation strength | Meets ASTM F2502 and USP<28> standards | Pass |
| pH | The difference should be 1.5 and less. | Pass |
| Potassium permanganate reducing substances | The difference of the consumption of potassium permanganate should be 2.0 mL and less. | Pass |
| Residue after evaporation | Record the weight of the residue should be 1.0mg and less. | Pass |
| Heavy metals | Any brown color produced within 10 minutes in the tube containing the extract of the prepared sample does not exceed that in the tube containing the standard lead solution. | Pass |
| UV spectrum (250nm~350nm) | Maximum absorbance between 250 to 350 nm should be 0.1 and less. | Pass |
| Property (Visual inspection) | Test solution should be clear and have no foreign particles. | Pass |
| Biocompatibility Tests (Anchor) | ||
| Cytotoxicity | Meets ISO 10993-5(2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Acute systemic toxicity test | Meets ISO 10993-11(2009) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| Pyrogen Test | Meets ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| Intracutaneous (intradermal) reactivity test | Meets ISO 10993-10(2013) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Maximization test for delayed hypersensitivity | Meets ISO 10993-10(2013) Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| Bacterial reverse mutation test | Meets ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
| Mammalian erythrocyte micronucleus test | Meets ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
| Implantation test | Meets ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| Bioabsorbable screws test | Meets ASTM F2502 Standard specification and test methods for bioabsorbable plates and screws for internal fixation implants | Pass |
| Subchronic toxicity test | Meets ISO 10993-11 Biological Evaluation of Medical Devices Part 11- Test for systemic toxicity | Pass |
| Biocompatibility Tests (Suture) | ||
| Cytotoxicity | Meets ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Systemic toxicity test | Meets ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| Pyrogen Test | Meets ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| Intracutaneous reactivity test | Meets ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Maximization sensitization | Meets ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| Genotoxicity test | Meets ISO 10993-3, Genotoxicity test OECE 471, Bacterial reverse mutation test | Pass |
| Implantation test | Meets ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| Hemolysis test | Meets ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Pass |
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria consists of a series of bench tests and biocompatibility tests. The document states:
"Bench test were performed. Bench testing included biocompatibility, mechanical testing including EO residues. The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device."
This means the device was subjected to physical, chemical, and biological evaluations according to recognized international and national standards (e.g., ASTM, USP, ISO). Each test had specific pass/fail criteria (as indicated in the "Requirements" or "Test method / Test criteria" columns of the tables), and the device successfully "passed" all of them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test set sample size: This information is not provided in the document. For bench and biocompatibility testing, sample sizes are typically determined by the specific test standards (e.g., number of test specimens for mechanical tests, number of animals for in vivo biocompatibility).
- Data provenance: The testing was conducted by AJU Pharm Co., Ltd. (company address in Korea) or subcontracted labs, according to international standards. The document does not specify the country of origin for each specific test report, but the manufacturer is based in Korea. These are prospective tests performed on the manufactured device.
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 evaluation involved objective physical, chemical, and biological testing against established standards, not interpretation by human experts to establish a "ground truth" in the clinical AI sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable. As stated above, the evaluation was based on objective laboratory measurements and adherence to specified test methods.
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. This document describes the regulatory submission for a physical medical implant (biocomposite anchor), not an AI/diagnostic software device. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by objective measurements and results from standardized bench tests and biocompatibility assays against predefined limits and criteria specified in the relevant ASTM, USP, and ISO standards. It is not based on expert consensus, pathology, or outcomes data in the context of clinical efficacy studies.
8. The sample size for the training set:
- This information is not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable. This is a physical medical device, not an AI model that requires a training set with established ground truth.
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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
{1}------------------------------------------------
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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:
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"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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
{3}------------------------------------------------
510(k) Summary
[as required by 807.92(c)]
1. Applicant
- Company : AJU Pharm Co.,Ltd. 1)
-
- Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
-
- Tel : 82-31-765-4420
- Fax : 82-31-602-7818 4)
-
- Prepared date : Jul. 4, 2016
-
- Contact person : Peter Chung, 412-512-8802
-
- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
-
- Submission date : Jul. 11, 2016
2. Device Information
- Trade name : Fixone Biocomposite Anchor 1)
-
- Common name : Biodegradable Orthopedic Bone Screw
- Regulation name : Fastener, Screw, Fixation, Bone, Suture 3)
-
- Product code : MAI
- Regulation number : 888.3030 5)
- ୧) Class of device : Class II
-
- 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;
{4}------------------------------------------------
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 permanganatereducing substances | The difference of the consumption of potassium permanganateshould 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 containingthe extract of the prepared sample does not exceed that in the tubecontaining 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 clearand 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 invitro cytotoxicity | Pass |
| 2 | Systemic toxicitytest | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests forsystemic toxicity | Pass |
{5}------------------------------------------------
| 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 areintended for fixation of suture (softtissue) to bone in the shoulder,foot/ankle, knee and elbow in thefollowing procedures:Shoulder : Rotor Cuff Repair, BankartRepair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular SeparationRepair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction;Foot/Ankle : Lateral Stabilization, MedialStabilization, 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 LigamentReconstruction. | Shoulder : Rotor Cuff Repair, BankartRepair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular SeparationRepair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction;Foot/Ankle : Lateral Stabilization, MedialStabilization, 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 LigamentReconstruction. | 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 BRAnchor | N/A |
| Appearance | Image: Two white, screw-like anchors | Image: Three white, screw-like anchors with drivers | Similar |
| Productconfiguration | DriverAnchorSuture | DriverAnchorSuture | 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 sterilizationAccording to ISO 11135: 2007 | EO Gas sterilizationAccording to ISO 11135: 2007 | Same |
| Biodegradable | Yes | Yes | Same |
| Principle ofoperation | 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 areintended for fixation of suture (softtissue) to bone in the shoulder,foot/ankle, knee and elbow in thefollowing procedures:Shoulder: Rotor Cuff Repair, BankartRepair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular SeparationRepair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction;Foot/Ankle: Lateral Stabilization, MedialStabilization, 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 LigamentReconstruction. | The Arthrex Bio-Corkscrew Suture Anchoris intended for fixation of suture to bonein the shoulder, foot/ankle, knee,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 | ||
| Productconfiguration | DriverAnchorSuture | DriverAnchorSuture | 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 sterilizationAccording to ISO 11135: 2007 | EO Gas sterilizationAccording to ISO 11135: 2007 | Same |
| Biodegradable | Yes | Yes | Same |
| Principle ofoperation | 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 areintended for fixation of suture (softtissue) to bone in the shoulder,foot/ankle, knee and elbow in thefollowing procedures:Shoulder : Rotor Cuff Repair, BankartRepair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular SeparationRepair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction;Foot/Ankle : Lateral Stabilization, MedialStabilization, 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 LigamentReconstruction. | Intended to be used for sutures or tissuefixation in the foot, ankle, knee, hand,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 |
| Productconfiguration | 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/5.75mm6.0mm/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/20.0mm24.0mm/24.5mm/28.0mm | Similar |
| Sterilization | EO Gas sterilizationAccording to ISO 11135: 2007 | EO Gas sterilizationAccording to ISO 11135: 2007 | Same |
| Biodegradable | Yes | Yes | Same |
| Principle ofoperation | 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.
§ 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.