(217 days)
The Fixone Biocomposite Small Anchor are intended to be used fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular 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 PP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral repair
The Fixone Biocomposite Small Anchor is intended for reattaching soft tissue to bone with sutures. It consists of Driver, Anchor, Non-absorbable suture and needle. A needle was attached to the end of the suture so that it could penetrate the damaged soft tissue to enable it to be used for OPEN surgery without arthroscopy. The anchor is manufactured from biodegradable materials (PLGA copolymer and beta-TCP). A non absorbable suture manufactured from co-braided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver.
The provided text is a 510(k) summary for the Fixone Biocomposite Small Anchor, a medical device intended for soft tissue to bone fixation. It details the device's characteristics, intended use, and performance data used to demonstrate substantial equivalence to a legally marketed predicate device.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided document:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Fixone Biocomposite Small Anchor are primarily based on demonstrating substantial equivalence to a predicate device (Arthrex SutureTak Suture Anchor) through a series of bench tests and biocompatibility evaluations. The "Requirements" column in the table implicitly defines the acceptance criteria, and the "Results" column indicates whether these criteria were met.
- Table of Acceptance Criteria and Reported Device Performance:
| Test Item / Category | Acceptance Criteria (Defined by Standard/Comparison) | Reported Performance / Result |
|---|---|---|
| Material Performance | ||
| External surface Measurement | Not explicitly stated (likely visual/dimensional inspection) | Pass |
| Insertion torque | ASTM F2502 and USP <28> (implies meeting specified torque ranges) | Pass |
| Fixation strength | Not explicitly stated (implied to be equivalent to predicate or safe for intended use) | Pass |
| Tensile strength | Not explicitly stated (implied to be equivalent to predicate or safe for intended use) | Pass |
| Extractable color | Not explicitly stated (likely visual inspection for absence of unapproved color) | Pass |
| Extraction test | Not explicitly stated (general requirement for extraction testing) | 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 | When observing it with the naked eye, test solution should be clear and have no foreign particles. | Pass |
| Performance Testing of Fixone® Biocomposite Anchor (Pull-out test) | ASTM F1839-08 (Standard for Rigid Polyurethane Foam, implies testing in a relevant bone model with expected retention) | Pass |
| Biocompatibility (Anchor) | ||
| Cytotoxicity | ISO 10993-5(2009) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Acute systemic toxicity test | ISO 10993-11(2009) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| Intracutaneous (intradermal) reactivity test | ISO 10993-10(2013) Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Maximization test for delayed hypersensitivity | ISO 10993-10(2013) Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| Bacterial reverse mutation test | ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test | Pass |
| Mammalian erythrocyte micronucleus test | ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test | Pass |
| Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| Bioabsorbable screws test | ASTM F2502 Standard specification and test methods for bioabsorbable plates and screws for internal fixation implants | Pass |
| Subchronic toxicity test | ISO 10993-11 Biological Evaluation of Medical Devices Part 11- Test for systemic toxicity | Pass |
| Biocompatibility (Suture) | ||
| Cytotoxicity | ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass |
| Systemic toxicity test | ISO 10993-11, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | Pass |
| Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| Intracutaneous reactivity test | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| Maximization sensitization | ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| Genotoxicity test | ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test | Pass |
| Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass |
| Hemolysis test | ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Pass |
Study Details:
The provided document describes a bench testing and biocompatibility testing study conducted to demonstrate the substantial equivalence of the Fixone Biocomposite Small Anchor to its predicate device. This is a common approach for Class II medical devices seeking 510(k) clearance, where clinical trials are often not required if substantial equivalence can be demonstrated through non-clinical data.
-
Sample Size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the specific number of units/samples used for each bench test (e.g., number of anchors for pull-out tests, number of extracts for chemical analysis). It simply states that "Bench test were performed." and "The tests demonstrated that the device performs in a substantially equivalent manner to the predicate device." For biocompatibility, it states "Test result" for each test, implying a sufficient number of test articles were used as per the specified ISO/ASTM standards.
- Data Provenance: The tests were performed by AJU Pharm Co.,Ltd. in Korea, which is the manufacturer. The data is retrospective, as it's presented after the tests were conducted.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of study (bench testing and biocompatibility) does not involve human experts establishing "ground truth" for a test set in the way an AI diagnostic study would where radiologists label images. The "ground truth" here is established by adherence to recognized international standards (ISO, ASTM, USP, OECD) and their inherent testing methodologies, which are designed to be objective and reproducible.
-
Adjudication method for the test set:
- Not Applicable. Adjudication methods (like 2+1 or 3+1 by experts) are pertinent to studies involving human interpretation or clinical outcomes, typically in AI/diagnostic device evaluations. For bench testing and biocompatibility, the results are typically quantitative or qualitative "pass/fail" outcomes based on pre-defined standard criteria.
-
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) use the device to assist in interpretation. The Fixone Biocomposite Small Anchor is a physical implant, not a diagnostic tool.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As a physical medical device (biocomposite anchor), the concept of "standalone algorithm only performance" does not apply. The device's performance is measured directly through physical and chemical properties and biological interactions, not through an algorithm.
-
The type of ground truth used:
- The "ground truth" for this device is based on established industry standards and regulatory requirements for medical device safety and performance. This includes:
- Biocompatibility Standards: ISO 10993 series for biological evaluation of medical devices (e.g., cytotoxicity, systemic toxicity, irritation, sensitization, genotoxicity, implantation).
- Material and Mechanical Testing Standards: ASTM (e.g., F2502 for bioabsorbable devices, F1839 for foam testing) and USP (pharmacopeial standards).
- Comparison to Predicate Device: The performance and safety profile of the predicate device (Arthrex SutureTak Suture Anchor) acts as a de facto "ground truth" for establishing substantial equivalence in terms of intended use, principle of operation, and general safety/performance characteristics.
- The "ground truth" for this device is based on established industry standards and regulatory requirements for medical device safety and performance. This includes:
-
The sample size for the training set:
- Not Applicable. There is no "training set" in the context of this device's evaluation. This is not an AI/machine learning device that requires training data. The device's design and manufacturing processes are established based on engineering principles and regulatory guidance, not learned from data.
-
How the ground truth for the training set was established:
- Not Applicable. Since there is no training set, there is no ground truth established for one.
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March 3, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
AJU Pharm Co., Ltd. % Peter Chung President Plus Global 300 Atwood St. Pittsburgh, Pennsylvania 15213
Re: K192032
Trade/Device Name: Fixone Biocomposite Small 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, MBI Dated: January 28, 2020 Received: February 3, 2020
Dear Peter 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Laura C. Rose, Ph.D. Acting 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) K192032
Device Name
Fixone Biocomposite Small Anchor
Image /page/2/Picture/6 description: The image shows the words "Indications for Use (Describe)". The words are in black font and are centered on the page. There is a line above the words.
The Fixone Biocomposite Small Anchor are intended to be used fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular 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 PP, DIP, and MCP joints for all digits, digital tendon transfers Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Hip: Capsular repair, Acetabular Labral repair
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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510(k) Summary [K192032]
1. Applicant
-
- Company : AJU Pharm Co.,Ltd.
-
- Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea
-
- Tel : 82-31-765-4420
-
- Fax : 82-31-602-7818
- ട) Prepared date : July 01, 2019
- (() Contact person : Peter Chung, 412-512-8802
-
- Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
-
- Submission date : Feb. 25, 2020
-
- Prior related submissions : K171299
2. Device Information
-
- Trade name : Fixone Biocomposite Small Anchor
-
- Common name : Biodegradable Orthopedic Bone Screw
-
- Regulation name : Single/multiple component metallic bone fixation appliances and accessories
-
- Product code : MAI, MBI
-
- Regulation number : 888.3080
- Class of device : Class II ର)
-
- Panel : Orthopedic
3. The legally marketed device to which we are claiming equivalence
K140855, Arthrex SutureTak Suture Anchor
4. Device description
The Fixone Biocomposite Small Anchor is intended for reattaching soft tissue to bone with sutures. It consists of Driver, Anchor, Non-absorbable suture and needle. A needle was attached to the end of the suture so that it could penetrate the damaged soft tissue to enable it to be used for OPEN surgery without arthroscopy. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-ΤCP). A non absorbable suture manufactured from co-braided UHMWPE and PET fibers is inserted into the anchor is implanted using a provided driver.
This device is to be used with instrument that manufactured by Aju Pharm Co.,Ltd listed in the table below. The instruments are provided non-sterile(user must sterilization before use).
| Product name | Drill bit and Drill guide with handle / Fixone.I.S-D/B300 and Fixone.I.S-D/G300 |
|---|---|
| Intended use | The instruments are used to make the hole in the bone for anchor placement. |
| Manufacturer | AJU Pharm Co.,Ltd. / Korea |
| Characteristic | This device is provided as Non-sterile and Reusable device.This device is user-sterilized. |
| Cleaning andSterilization process | Before use, user must proceed cleaning and sterile process.Sterilization process : Steam sterilizationTemperature 132°C (270°F) / Operating time 4min / Drying 20 min |
5. Intended Use :
The Fixone Biocomposite Small Anchor are intended to be used for suture (soft tissue) fixation to bone in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular 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
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Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/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 Hip: Capsular repair, Acetabular Labral repair
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 surfaceMeasurement | ||
| Insertion torque | ASTM F2502 and USP<28> | |
| Fixation strength | 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 permanganate shouldbe 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 theextract 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 clear andhave no forign particles. | |
| Performance Testing of Fixone® Biocomposite Anchor (Pull-out test)Pull-out test by immersion time of saline solution to evaluate two bioabsorbable suture anchors.[Absorption time (soaking time) : 4 weeks, 6 weeks, 12 weeks and 26 weeksASTM F1839-08, Standard specification for RGID Polyurethane Foam for Use as a Standard Material forTesting Orthopaedic Devices and Instruments | ||
| Pass |
2) Biocompatibility
Anchor
| # | Test item | Test method / Test criteria | Test result |
|---|---|---|---|
| 1 | Cytotoxicity | ISO 10993-5(2009) Biological evaluation of medical devices - Part5: Tests for in vitro cytotoxicity | Pass |
| 2 | Acute systemic toxicitytest | 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 fordelayed hypersensitivity | ISO 10993-10(2013) Test for irritation and skin sensitization,Maximization test for delayed hypersensitivity | Pass |
| 6 | Bacterial revers mutationtest | ISO 10993-3, Genotoxicity test OECE 471, Bacterial reversemutation test | Pass |
| 7 | Mammalian erythrocytemicronucleus test | ISO 10993-3, Genotoxicity test OECE 471, Bacterial reversemutation test | Pass |
| 8 | Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex Dtest methods for implantation in bone | Pass |
| 9 | Bioabsorbable screws test | ASTM F2502 Standard specification and test methods forbioabsorbable plates and screws for internal fixation implants | Pass |
| 10 | Subchronic toxicity test | ISO 10993-11 Biological Evaluation of Medical Devices Part 11- | Pass |
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| Test for systemic toxicity | |||
|---|---|---|---|
| # | Test item | Test method / Test criteria | Test result |
| Suture | |||
| 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 |
| 3 | Pyrogen Test | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass |
| 4 | Intracutaneous reactivity test | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass |
| 5 | Maximization sensitization | ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass |
| 6 | Genotoxicity 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 | Hemolysis test | ISO 10993-4, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | Pass |
The performance tests demonstrated that Fixone Biocomposite Small Anchor performs in a substantially equivalent manner to the predicate device.
7. Predicate device comparison table
| Manufacturer | AJU Pharm Co.,Ltd. | Arthrex Inc. | Remark |
|---|---|---|---|
| 510(k) No. | K140855 | N/A | |
| Indication for use | The Fixone Biocomposite Small Anchor areintended to be used for suture (soft tissue)fixation to bone in the foot, ankle, knee,hand, wrist, elbow, shoulder, and hip.Shoulder: Rotator Cuff Repair, BankartRepair, SLAP Lesion Repair, Biceps Tenodesis,Acromio-Clavicular Separation Repair,Deltoid Repair, Capsular Shift orCapsulolabral ReconstructionFoot/Ankle: Lateral Stabilization, MedialStabilization, Achilles Tendon Repair,Metatarsal Ligament Repair, Hallux Valgusreconstruction, digital tendon transfers, Mid-foot reconstructionKnee: Medial Collateral Ligament Repair,Lateral Collateral Ligament Repair, PatellarTendon Repair, Posterior Oblique LigamentRepair, Iliotibial Band TenodesisHand/Wrist: Scapholunate LigamentReconstruction, Carpal LigamentReconstruction, Repair/Reconstruction ofcollateral ligaments, Repair of Flexor andExtensor Tendons at the PIP, DIP, and MCPjoints for all digits, digital tendon transfersElbow: Biceps Tendon Reattachment, Ulnaror Radial Collateral Ligament ReconstructionHip: Capsular repair, Acetabular Labral repair | The Arthrex SutureTak Suture Anchors areintended to be used for suture (soft tissue)fixation to bone in the foot, ankle, knee,hand, wrist, elbow, shoulder, and hip.Shoulder: Rotator Cuff Repair, BankartRepair, SLAP Lesion Repair, Biceps Tenodesis,Acromio-Clavicular Separation Repair,Deltoid Repair, Capsular Shift orCapsulolabral ReconstructionFoot/Ankle: Lateral Stabilization, MedialStabilization, Achilles Tendon Repair,Metatarsal Ligament Repair, Hallux Valgusreconstruction, digital tendon transfers, Mid-foot reconstructionKnee: Medial Collateral Ligament Repair,Lateral Collateral Ligament Repair, PatellarTendon Repair, Posterior Oblique LigamentRepair, Iliotibial Band TenodesisHand/Wrist: Scapholunate LigamentReconstruction, Carpal LigamentReconstruction, Repair/Reconstruction ofcollateral ligaments, Repair of Flexor andExtensor Tendons at the PIP, DIP, and MCPjoints for all digits, digital tendon transfersElbow: Biceps Tendon Reattachment, Ulnaror Radial Collateral Ligament ReconstructionHip: Capsular repair, Acetabular Labral repair | Same |
| Classificationname | Single/multiple component metallic bone fixation appliances and accessories | Single/multiple component metallic bone fixation appliances and accessories | Same |
| Trade name | Fixone Biocomposite Small Anchor | Arthrex SutureTak Suture Anchor | N/A |
| Model/type | 9 model codes including SAB-30001a | 3 model codes including 2.4mmx6.5mmMicro SutureTak | N/A |
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006_510(k) Summary
| Manufacturer | AJU Pharm Co.,Ltd. | Arthrex Inc. | Remark |
|---|---|---|---|
| Appearance | Image: AJU Pharm Co., Ltd. Anchor | Image: Arthrex Inc. Anchor | Similar |
| Productconfiguration | Driver, Anchor, Suture and Needle | Driver, Anchor, Suture and Needle | Same |
| Material | PLGA + β-TCP | PLDLA + β-TCP | Different |
| Anchor | |||
| Outside diameter | 3.0mm | 2.4mm, 3.0mm | Similar |
| Length of anchor | 11.9mm | 6.5mm, 8.5mm, 14mm | Different |
| Suture | |||
| Absorbable | Non-absorbable | Non-absorbable | Same |
| Suture diameter | USP size #0 | USP size 0 and #1 | Same |
| Biodegradable | Yes | Yes | Same |
| Principle ofoperation | Manual | Manual | Same |
9. Conclusion
The device is investigated for function to compare the operation of function between Fixone Biocomposite Small 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 Small 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.