(113 days)
Not Found
No
The summary describes a physical implantable device (suture anchor) and its intended use for tissue fixation. There is no mention of software, algorithms, image processing, AI, ML, or data analysis, which are typically associated with AI/ML medical devices.
No.
The device is an anchor used for the fixation of suture to bone in various orthopedic procedures, serving as a fixation device rather than directly treating a disease or condition.
No
The device description clearly states its intended use is for reattaching soft tissue to bone with sutures, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical anchor manufactured from biodegradable materials and implanted using a driver, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Description and Intended Use: The Fixone Biocomposite Anchors are described as implants used to fix soft tissue to bone within the body during surgical procedures. They are physical devices used for structural support and repair, not for analyzing biological samples.
The information provided clearly indicates a surgical implant, not a diagnostic test performed on samples outside the body.
N/A
Intended Use / Indications for 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
MAI
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-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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder, Foot/Ankle, Knee, Elbow
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. The following bench testing is performed to demonstrate the functionality is substantially equivalent.
Test Item include: External surface, Measurement, Insertion torque, Fixation strength (ASTM F2502 and USP), Tensile strength, Extractable color, Extraction test, pH (The difference should be 1.5 and less), Potassium permanganate reducing substances (The difference of the consumption of potassium permanganate 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 the extract of the prepared sample does not exceed that in the tube containing the standard lead solution), 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 and have no forign particles). All results passed.
Biocompatibility tests for Anchor include: Cytotoxicity (ISO 10993-5(2009)), Acute systemic toxicity test (ISO 10993-11(2009)), Pyrogen Test (ISO 10993-11 Test for systemic toxicity, pyrogen test), Intracutaneous(intradermal) reactivity test (ISO 10993-10(2013)), Maximization test for delayed hypersensitivity (ISO 10993-10(2013)), Bacterial revers mutation test (ISO 10993-3, Genotoxicity test OECE 471), Mammalian erythrocyte micronucleus test (ISO 10993-3, Genotoxicity test OECE 471), Implantation test (ISO 10993-6, Annex D test methods for implantation in bone), Bioabsorbable screws test (ASTM F2502), Subchronic toxicity test (ISO 10993-11). All results passed.
Biocompatibility tests for Suture include: Cytotoxicity (ISO 10993-5), Systemic toxicity test (ISO 10993-11), Pyrogen Test (ISO 10993-11), Intracutaneous reactivity test (ISO 10993-10), Maximization sensitization (ISO 10993-10), Genotoxicity test (ISO 10993-3), Implantation test (ISO 10993-6), Hemolysis test (ISO 10993-4). All results passed.
The performance tests demonstrated that Fixone Biocomposite Anchor performs in a substantially equivalent manner to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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 | Pass |
| Tensile strength | ||
| Extractable color | ||
| Extraction test | ||
| pH | The difference should be 1.5 and less. | |
| Potassium permanganate | ||
| reducing substances | The difference of the consumption of potassium permanganate | |
| 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 | |
| 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. | |
| Property | When observing it with the naked eye, test solution should be clear | |
| 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 | |
| vitro cytotoxicity | Pass | ||
| 2 | Systemic toxicity | ||
| test | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for | ||
| systemic 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 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. | 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. | 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 | |
| Anchor | N/A | ||
| Appearance | Image: Two white, screw-like anchors | Image: Three white, screw-like anchors with drivers | Similar |
| Product | |||
| configuration | Driver | ||
| Anchor | |||
| Suture | Driver | ||
| Anchor | |||
| 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 | ||
| According to ISO 11135: 2007 | EO Gas sterilization | ||
| According to ISO 11135: 2007 | Same | ||
| Biodegradable | Yes | Yes | Same |
| Principle of | |||
| 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 | ||
| 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. | The Arthrex Bio-Corkscrew Suture Anchor | ||
| is intended for fixation of suture to bone | |||
| in 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 | ||
| Product | |||
| configuration | Driver | ||
| Anchor | |||
| Suture | Driver | ||
| Anchor | |||
| 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 | ||
| According to ISO 11135: 2007 | EO Gas sterilization | ||
| According to ISO 11135: 2007 | Same | ||
| Biodegradable | Yes | Yes | Same |
| Principle of | |||
| 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 | ||
| 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. | Intended to be used for sutures or tissue | ||
| fixation 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 |
| Product | |||
| 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 | ||
| 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 | |
| 24.0mm/24.5mm/28.0mm | Similar | ||
| Sterilization | EO Gas sterilization | ||
| According to ISO 11135: 2007 | EO Gas sterilization | ||
| According to ISO 11135: 2007 | Same | ||
| Biodegradable | Yes | Yes | Same |
| Principle of | |||
| 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.