← Product Code [MAI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI) · K203523 # Fixone hybrid knotless anchor (K203523) _Aju Pharm Co., Ltd. · MAI · Dec 25, 2021 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI/K203523 ## Device Facts - **Applicant:** Aju Pharm Co., Ltd. - **Product Code:** [MAI](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI.md) - **Decision Date:** Dec 25, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.3030 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Fixone Hybrid Knotless Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; 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 Hybrid Knotless Anchor facilitates soft tissue-to-bone reattachment using sutures; device consists of biodegradable anchor body (PLGA copolymer and β-TCP) and nonabsorbable PEEK tip; includes cobraided UHMWPE and PET fiber sutures. Implanted manually by surgeons in clinical settings (OR) using provided driver instrument. Device provides mechanical fixation; surgeon uses output (suture tensioning) to secure soft tissue to bone. Benefits include stable tissue fixation during healing. Device is non-sterile; requires user-performed autoclave sterilization (132°C) before use. ## Clinical Evidence Bench testing only. No clinical data provided. Testing included biocompatibility (ISO 10993 series), mechanical performance (ASTM F2502, F1839), shelf-life (real-time and accelerated aging per ASTM F1980-02), and EO sterilization validation (ISO 11135). All tests passed. ## Technological Characteristics Anchor body: PLGA copolymer and β-TCP; Tip: PEEK; Suture: UHMWPE and PET fibers. Driver: Stainless steel 304. Manual operation. Dimensions: 4.75mm/5.5mm diameter; 14.7mm/15mm length. Sterilization: User-performed autoclave (132°C/4min). ## Regulatory Identification Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Fixone Biocomposite Anchor ([K192484](/device/K192484.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ December 25, 2021 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. AJU Pharm Co., Ltd. % Peter Chung President Plus Global 300 Atwood Pittsburgh, Pennsylvania 15213 Re: K203523 Trade/Device Name: Fixone Hybrid Knotless 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: November 19, 2021 Received: November 23, 2021 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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203523 Device Name Fixone Hybrid Knotless Anchor The Fixone Hybrid Knotless Anchor is 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) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." BR PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ # 510(k) Summary #### 1. Applicant - Company : AJU Pharm Co.,Ltd. 1) - 2) Address : A-207, 697, Pangyo-ro, Seongnam-si, Gyeonggi-do, Korea - 3) Tel : 82-31-765-4420 - 4) Fax : 82-31-602-7818 - Prepared date : Nov. 09. 2020 5) - () Contact person : Peter Chung, 412-512-8802 - 7) Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA - 8) Submission date : Dec. 22. 2021 - ರು) Submission type : Traditional - 10) Prior related submissions : K192484 Kc type anchor #### 2. Device Information - Trade name : Fixone Hybrid knotless Anchor 1) - 2) Common name : Fastener, Fixation, Biodegradable, Soft tissue - Regulation name : Single/multiple component metallic bone fixation appliances and accessories 3) - 4) Product code : MAI, MBI - ട്) Regulation number : 888.3030 - ୧) Class of device : Class II - 7) Panel : Orthopedic #### 3. The legally marketed device to which we are claiming equivalence K192484, Aju Pharm Co., Ltd. / Fixone Biocomposite Anchor (Especially Kc Type) #### 4. Device description The Fixone Hybrid Knotless Anchor is intended for reattaching soft tissue to bone with sutures. The anchor is manufactured from biodegradable materials (PLGA copolymer and β-TCP) and nonabsorbable PEEK tip. A nonabsorbable suture manufactured from cobraided UHMWPE and PET fibers is inserted into the anchor. 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 11 models. It provide non-sterile (user must sterilization before use). | Product name | Instrument / 11 model codes including | |----------------------|-------------------------------------------------------------------------------------------------------------------------------------| | Intended use | The instrument of make the hole in the bone. | | Manufacturer | AJU Pharm Co.,Ltd. / Korea | | Characteristic | This device is provided as Non-sterile and Reusable device.
This device is provided non-sterile. This device is user-sterilized. | | Sterilization method | Autoclave / 132°C / 4min / 20 min dry | #### 5. Intended Use : ## The Fixone Hybrid Knotless Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee and elbow in the following procedures: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction; Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair; 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. {4}------------------------------------------------ # 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 | According to test methods of ASTM F2502 and USP<28> | | | Measurement | Surface and measurement : Using vernier caliper, micrometer or a tape measure, should be within 5% of the dimension specified in specifications. | | | Insertion torque | Insertion torque : Drive the specimen into the test block(ASTM F1839) at a rate of 1r/min. Should not be less than 0.15Nm. | | | Fixation strength | Fixation : Apply a compressive load to the test specimen at a rate of 5mm/min. Should not be less than 100N. | Pass | | Tensile strength | Tensile strength : measuring 10 suture threads with stretching. Should not be less than 34.5N | | | Torsional Test | Torsional test : Apply torsional load to the test specimen at a rate of 5r/min. This maximum torque should not be less than insertion torque.
Fixation anchor could endure movement of tissues and bones.
Arthrex did pull out and cyclic pull-out testing to support device performance. | | | 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 foreign particles. | | | Pyrogen | Material-mediated pyrogens
ISO10993-11, USP39<151> | Pass | | Shelf life testing | To make shelf life time, my company set Real-time equivalent (RTE) and Accelerated aging
temperature, Taa as per AAMI TIR17 and ASTM F 1980-02.
Aging temperature: 55±2°C, aging time: 229 days | Pass | | Shelf life testing(Real-time) | This aims to verify that this product is valid for 5 years (60 months) by testing physicochemical
changes and packaging of the materials and the product at six times points before real time aging
(0 year), middle real time aging (1 year, 2 years, 3 years, 4years) and after real time aging (5
years) on the evaluation of validity and safety for medical appliances by ISO 11607-1:2006, ISO
11607-2:2006. | Pass | | EO sterilization Validation
(EO residual test in EO
sterilization Validation
report) | ISO11135(2014) | Pass | {5}------------------------------------------------ #### 2) Biocompatibility | # | 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 | Maximization test for delayed hypersensitivity | ISO 10993-10, Tests for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass | | 3 | Intracutaneous reactivity | ISO 10993-10, Tests for irritation and skin sensitization, Intracutaneous(Intradermal)Reactivity Test | Pass | | 4 | Acute Systemic toxicity | ISO 10993-11 Test for systemic toxicity, Acute Systemic toxicity | Pass | | 5 | Material-mediated Pyrogen | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass | | 6 | Sub acute Systemic toxicity | ISO 10993-11 Test for systemic toxicity, Systemic toxicity | Pass | | 7 | Bacterial reverse mutation test | ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test | Pass | | 8 | Mammalian erythrocyte micronucleus test | ISO 10993-3, Genotoxicity test OECD 474, Mammalian erythrocyte micronucleus test | Pass | | 9 | Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test methods for implantation in bone | Pass | {6}------------------------------------------------ | | 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 | Maximization test
for delayed
hypersensitivity | ISO 10993-10, Tests for irritation and skin sensitization, Maximization
test for delayed hypersensitivity | Pass | | | | 3 | Intracutaneous
reactivity | ISO 10993-10, Tests for irritation and skin sensitization, Intracutaneous
(Intradermal)Reactivity Test | Pass | | | | 4 | Acute Systemic
toxicity | ISO 10993-11 Test for systemic toxicity, Acute Systemic toxicity | Pass | | | | 5 | Material-mediated
Pyrogen | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass | | | | 6 | Sub acute Systemic
toxicity | ISO 10993-11 Test for systemic toxicity, Systemic toxicity | Pass | | | | 7 | Bacterial reverse
mutation test | ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test | Pass | | | | 8 | Mammalian
erythrocyte
micronucleus test | ISO 10993-3, Genotoxicity test OECD 474, Bacterial reverse mutation test | Pass | | | | 9 | Implantation test | ISO 10993-6, Tests for local effects after implantation(4weeks) | Pass | | | | | | ISO 10993-6, Tests for local effects after implantation(12weeks) | Pass | | | | 10 | Biological risk
assessment | This assessment and evaluation plan focuses on the requirements of ISO
10993-1:2009 - Biological evaluation of medical devices – Part 1:
Evaluation and testing within a risk management process, EN ISO
14971:2012 - Medical devices – Application of risk management to
medical devices, FDA General Program Memorandum #G95-1, Use of
International Standard ISO-10993, Biological Evaluation of Medical
Devices Part 1: Evaluation and Testing, and the European Union Medical
Device Directive 93/42/EEC.1,2,3,4 It examines the components used in
the device, information on the device materials in the literature, and the
history of safe and effective use of the device materials in humans. | - | | | | Tip | | | | |-----|--------------|----------------------------------------------------------------------------------------------------|-------------| | # | 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 | {7}------------------------------------------------ | 2 | Maximization test
for delayed
hypersensitivity | ISO 10993-10, Tests for irritation and skin sensitization, Maximization
test for delayed hypersensitivity | Pass | |---|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------| | 3 | Intracutaneous
reactivity | ISO 10993-10, Tests for irritation and skin sensitization,
Intracutaneous(Intradermal)Reactivity Test | Pass | | 4 | Acute Systemic
toxicity | ISO 10993-11 Test for systemic toxicity, Acute Systemic toxicity | Pass | | 5 | Material-mediated
Pyrogen | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass | | 6 | Sub acute Systemic
toxicity | ISO 10993-11 Test for systemic toxicity, Systemic toxicity | Pass | | 7 | Bacterial reverse
mutation test | ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test | Pass | | 8 | Mammalian
erythrocyte
micronucleus test | ISO 10993-3, Genotoxicity test OECD 474, Bacterial reverse mutation test | Pass | | 9 | Implantation test | ISO 10993-6, Tests for local effects after implantation, Annex D test
methods for implantation in bone | Pass | # Suture(White(B), Black(90%)/White(10%), Black(50%)/White(50%), Black(10%)/White(90%), Black(100%)) (Newly added information) | # | 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 | Maximization test
for delayed
hypersensitivity | ISO 10993-10, Tests for irritation and skin sensitization, Maximization
test for delayed hypersensitivity | Pass | | 3 | Intracutaneous
reactivity | ISO 10993-10, Tests for irritation and skin sensitization, Intracutaneous
(Intradermal)Reactivity Test | Pass | | 4 | Acute Systemic
toxicity | ISO 10993-11 Test for systemic toxicity, Acute Systemic toxicity | Pass | | 5 | Material-mediated
Pyrogen | ISO 10993-11 Test for systemic toxicity, pyrogen test | Pass | | 6 | Sub chronic
Systemic toxicity | ISO 10993-11 Test for systemic toxicity, Sub chronic Systemic toxicity | Pass | {8}------------------------------------------------ | 7 | Bacterial reverse
mutation test | ISO 10993-3, Genotoxicity test OECD 471, Bacterial reverse mutation test | Pass | |---|-----------------------------------------------|-------------------------------------------------------------------------------------|------| | 8 | Mammalian
erythrocyte
micronucleus test | ISO 10993-2, Genotoxicity test OECD 474, Mammalian erythrocyte
micronucleus test | Pass | | 9 | Implantation test | ISO 10993-6, Tests for local effects after implantation(4weeks) | Pass | | | | ISO 10993-6, Tests for local effects after implantation(12weeks) | Pass | ## Driver shaft (Stainless steel 304) | # | 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 | Intracutaneous
reactivity test | ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass | | 3 | Maximization
sensitization | ISO 10993-10, Test for irritation and skin sensitization, Maximization test for delayed hypersensitivity | Pass | #### Endotoxin test | # | Test item | Test method / Test criteria | Test result | |---|-----------|---------------------------------------------|-------------| | 1 | Endotoxin | USP 43 <85>, Bacterial endotoxin test (LAL) | Pass | Endotoxin level and EO sterilization will be monitored In an alternative plan to batch testing. The performance tests demonstrated that Fixone Hybrid Knotless Anchor performs in a substantially equivalent manner to the predicate device. ## 7. Predicate device comparison table | Manufacturer | AJU Pharm Co.,Ltd. | AJU Pharm Co.,Ltd. | Remark | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------| | 510(k) No. | K192484 | K203523 | 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: Rotator Cuff Repair, Bankart
Repair, SLAP Lesion Repair, Biceps
Tenodesis, Acromio-Clavicular Separation
Repair, Deltoid Repair, Capsular Shift or
Capsulolabral Reconstruction;

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

Knee: Medial Collateral Ligament Repair,
Lateral Collateral Ligament Repair,
Posterior Oblique Ligament Repair,
Iliotibial Band Tenodesis; | The Fixone Hybrid Knotless Anchors are
intended for fixation of suture (soft
tissue) to bone in the shoulder,
foot/ankle, knee and elbow in the
following procedures:

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

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

Knee: Medial Collateral Ligament Repair,
Lateral Collateral Ligament Repair,
Posterior Oblique Ligament Repair, | Same | | Manufacturer | AJU Pharm Co.,Ltd. | AJU Pharm Co.,Ltd. | Remark | | | Iliotibial Band Tenodesis;
Elbow: Biceps Tendon Reattachment,
Ulnar or Radial Collateral Ligament
Reconstruction. | Elbow: Biceps Tendon Reattachment,
Ulnar or Radial Collateral Ligament
Reconstruction. | | | Classification name | Fastener, Fixation, Biodegradable, Soft tissue | Fastener, Fixation, Biodegradable, Soft tissue | Same | | Trade name | Fixone Biocomposite Anchor | Fixone Hybrid Knotless Anchor | | | Model/type | 161 model codes including BAB-45001a | 8 models include KAP-47501ca | N/A | | Product
configuration | Driver | Driver | Same | | | Anchor | Anchor | | | | Suture | Suture | | | Material | PLLA + β-TCP | PLGA + β-TCP
PEEK | PEEK | | | | PEEK | | | Anchor | | | | | Outside diameter | 3.0mm/4.5mm/4.75mm
5.5mm/5.75mm/6.5mm | 4.75mm / 5.5mm | Same
(Included) | | Length of anchor | 11.9mm/14.6mm/15mm/15.7mm
16mm/16.5mm/16.8mm | 14.7mm / 15 mm | Same
(Included) | | Length of tip | 10.5mm | 10.5mm | Same | | 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 | UHMWPE | UHMWPE+PET (Colored suture)
UHMWPE (Black, White) | Similar | | Sterilization | EO Gas sterilization
According to ISO 11135: 2014 | EO Gas sterilization
According to ISO 11135: 2014 | Same | | Biodegradable | Yes | Yes | Same | | Principle of
operation | Manual | Manual | Same | | Shelf-life | 5 years | 5 years | Same | {9}------------------------------------------------ PEEK : This is the only different part between subject and predicate device. ## 8. Conclusion The device is investigated for function to compare the operation of function between Fixone Hybrid Knotless Anchor {10}------------------------------------------------ and predicate devices. The subject device was made very similarly with the kc type anchor in K192484. The material of tip is the only different thing. Biodegradable material, PLGA + β-TCP was used in the tip of KC type. Non-biodegradable material, PEEK was used in the tip of subject device. Other materials, mechanical properties, appearance and using methods are all same. The tip of KP type of PEEK is non-biodegradable material that compared to PLGA + β-TCP. 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 Hybrid Knotless Anchor is substantially equivalent to the legally marketed predicate device. --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI/K203523](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAI/K203523) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com