(87 days)
Not Found
No
The 510(k) summary describes a mechanical implant system for fracture repair and syndesmosis fixation. There is no mention of AI or ML in the intended use, device description, or performance studies. The mentions of image processing relate to MRI compatibility testing, not AI/ML-based image analysis.
Yes
The device is described as providing "fixation during the healing process following a syndesmotic trauma," indicating its direct role in supporting the body's healing of an injury.
No
The device is described as an implant system (Arthrex Syndesmosis TightRope XP Buttress Plate Implant System) intended to provide fixation during the healing process following syndesmotic trauma, not to diagnose a condition.
No
The device description explicitly states that the system consists of physical components, including a metal plate, buttons, suture, and ancillary instruments. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) for fracture repair and fixation during the healing process. IVDs are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is an implantable system consisting of plates, sutures, and instruments for surgical insertion. This is consistent with a surgical implant, not an IVD.
- No mention of analyzing biological specimens: The description focuses on the mechanical and physical properties of the implant and its use in surgical procedures. There is no mention of analyzing blood, urine, tissue, or any other biological specimen, which is the core function of an IVD.
The mentions of MRI testing and performance studies relate to the safety and efficacy of the implantable device in the context of its intended surgical use, not to diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
Product codes (comma separated list FDA assigned to the subject device)
HTN
Device Description
The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System consists of one 2 Hole Syndesmosis Buttress Plate (titanium alloy), two Knotless TightRopes (titanium alloy buttons and UHMWPE braid suture) and various ancillary instruments to aid in insertion. The proposed Arthrex Buttress Plate is a metal plate manufactured from either titanium alloy or stainless steel. The implantable devices are packaged with various ancillary instruments to aid in insertion. The implantable devices and various ancillary instruments are provided sterile and are single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle (specifically, areas involved in syndesmosis disruptions in connection with Weber B and C ankle fractures)
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)
Cyclic fatigue testing was conducted to demonstrate that the proposed Arthrex Syndesmosis TightRope XP Buttress Plate Implant System performs statistically equivalent to the predicate device cleared under K043248.
MRI force, torque, and image artifact testing were conducted in accordance with FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment, ASTM F2052 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard Test Method for Measurement of Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM F2213 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.
Bacterial Endotoxins Test (BET) was performed on the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP, EP 2.6.14. The testing conducted demonstrates that the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System meets pyrogen limit specifications.
Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted on the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System in accordance with ISO 10993-1:2018.
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/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized emblem. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
September 3, 2020
Arthrex Inc. Rebecca R. Homan Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108
Re: K201522
Trade/Device Name: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HTN Dated: June 4, 2020 Received: June 8, 2020
Dear Ms. Homan:
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
1
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 (QS) 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. 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)
Device Name
Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
Indications for Use (Describe)
The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| × Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Date Prepared | September 3, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System |
| Common Name | Button/Suture |
| Product Code | HTN |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallic bone fixation appliances |
| and accessories | |
| Regulatory Class | II |
| Predicate Device | K043248: Arthrex TightRope Syndesmosis Devices |
| Purpose of | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| Submission | the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System. |
| Device Description | The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System consists of |
| one 2 Hole Syndesmosis Buttress Plate (titanium alloy), two Knotless TightRopes | |
| (titanium alloy buttons and UHMWPE braid suture) and various ancillary | |
| instruments to aid in insertion. The proposed Arthrex Buttress Plate is a metal | |
| plate is manufactured from either titanium alloy or stainless steel. The | |
| implantable devices are packaged with various ancillary instruments to aid in | |
| insertion. The implantable devices and various ancillary instruments are provided | |
| sterile and are single use. | |
| Indications for Use | The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is intended |
| as an adjunct in fracture repair involving metaphyseal and periarticular small | |
| bone fragments where screws are not indicated, and as an adjunct in external | |
| and intramedullary fixation systems involving plates and rods, with fracture | |
| braces and casting. | |
| Specifically, the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | |
| is intended to provide fixation during the healing process following a syndesmotic | |
| trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection | |
| with Weber B and C ankle fractures. | |
| Performance Data | Cyclic fatigue testing was conducted to demonstrate that the proposed Arthrex |
| Syndesmosis TightRope XP Buttress Plate Implant System performs statistically | |
| equivalent to the predicate device cleared under K043248. | |
| MRI force, torque, and image artifact testing were conducted in accordance with | |
| FDA guidance Testing and Labeling Medical Devices for Safety in the Magnetic | |
| Resonance (MR) Environment, ASTM F2052 Standard Test Method for | |
| Measurement of Magnetically Induced Displacement Force on Medical Devices in | |
| the Magnetic Resonance Environment, ASTM F2119 Standard Test Method for | |
| Evaluation of MR Image Artifacts from Passive Implants, ASTM F2182 Standard | |
| Test Method for Measurement of Measurement of Radio Frequency Induced | |
| Heating Near Passive Implants During Magnetic Resonance Imaging and ASTM | |
| F2213 Standard Test Method for Measurement of Magnetically Induced Torque | |
| on Medical Devices in the Magnetic Resonance Environment. | |
| Bacterial Endotoxins Test (BET) was performed on the Arthrex Syndesmosis | |
| TightRope XP Buttress Plate Implant System utilizing the Kinetic Chromogenic | |
| Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP | |
| , EP 2.6.14. The testing conducted demonstrates that the Arthrex | |
| Syndesmosis TightRope XP Buttress Plate Implant System meets pyrogen limit | |
| specifications. | |
| Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, | |
| Subchronic/Subacute Toxicity, Implantation and Material Characterization testing | |
| was conducted on the Arthrex Syndesmosis TightRope XP Buttress Plate Implant | |
| System in accordance with ISO 10993-1:2018. | |
| Technological | |
| Comparison | Assessment of physical product attributes including product, design, size, and |
| materials as well as the conditions of manufacture and packaging has determined | |
| that the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System does | |
| not introduce additional risks or concerns regarding sterilization and shelf-life. | |
| The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is | |
| substantially equivalent to the predicate devices cleared under K043248 in which | |
| the basic design features, intended use, materials, fundamental scientific | |
| technology, indications for use, sterility and shelf-life are identical. |
The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System contains a
preloaded disposable inserter and an Arthrex Buttress Plate. The predicate
devices cleared under K043248 did not contain a preloaded disposable inserter or
an Arthrex Buttress Plate.
The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System has been
evaluated for MR Conditional labeling; whereas the predicate devices cleared
under K043248 were not evaluated for MR Conditional labeling.
The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is a line
extension to the predicate devices, which include minor dimensional
modifications with no change to intended use or function. Any differences
between the Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
and the predicate devices are considered minor and do not raise different
questions of safety or effectiveness. |
| Conclusion | The Arthrex Syndesmosis TightRope XP Buttress Plate Implant System is
substantially equivalent to the predicate device in which the basic design features
and intended uses are the same. Any differences between the proposed device
and the predicate device are considered minor and do not raise different
questions concerning safety or effectiveness.
The submitted mechanical testing data demonstrates that the ultimate tensile
strength and cyclic fatigue of the proposed device is substantially equivalent to
that of the predicate device for the desired indications.
Based on the indications for use, technological characteristics, and the summary
of data submitted, Arthrex Inc. has determined that the proposed device is
substantially equivalent to the currently marketed predicate device. |
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