(131 days)
No
The summary describes a mechanical screw for tissue fixation and does not mention any AI/ML components or functionalities.
No
The device is described as a screw intended for suture or tissue fixation, which is a structural or supportive function rather than a therapeutic one (e.g., delivering medication, stimulating a biological response, or facilitating rehabilitation).
No
The device is described as a screw intended for suture or tissue fixation in various anatomical locations. Its function is to provide mechanical support for repairs and reconstructions, not to diagnose a condition.
No
The device description clearly states it is a physical screw made of PEEK, intended for surgical implantation. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside of the body.
- Arthrex 2.5 mm Tenodesis Screw Function: The description clearly states that this device is a screw intended for suture or tissue fixation within the body during surgical procedures. It is an implantable device used to physically hold tissues together.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples, perform tests, or provide diagnostic information about a patient's condition. Its purpose is purely mechanical and structural.
The information provided describes a surgical implant, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Arthrex 2.5 mm Tenodesis Screw is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
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
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
Product codes
HWC, MBI
Device Description
The Arthrex 2.5 mm Tenodesis Screw is a fully threaded, cannulated screw with a rounded head. The screw will be offered in a 2.5 mm diameter and 6 mm length. The screw is manufactured from Polyetheretherketone (PEEK). The screw is sold as sterile, single-use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
foot, ankle, knee, hand, wrist, elbow, and shoulder
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)
Pull-out and failure torque/insertion torque testing were conducted to demonstrate that the Arthrex 2.5 mm Tenodesis Screw performs statistically equivalent to the predicate device cleared under K063479.
The Arthrex 2.5 mm Tenodesis Screw is sterilized by ethylene oxide (EO). The sterility assurance level (SAL) is 10⁻⁶. This is identical to the predicate devices cleared under K063479 and K172612.
The shelf life of the Arthrex 2.5 mm Tenodesis Screw is five (5) years for the Polyetheretherketone (PEEK) material, which is identical to the predicate devices cleared under K063479 and K172612.
Bacterial Endotoxins Test (BET) was performed on the Arthrex 2.5 mm Tenodesis Screw utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14. Testing was performed in compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR Parts 210, 211 and 820. The testing conducted demonstrates that the Arthrex 2.5 mm Tenodesis Screw meets pyrogen limit specifications.
Cytotoxicity, Sensitization, Irritaion, Genotoxicity, Systemic Toxicity, Subchronic/Subacute Toxicity, Implantation and Material Characterization testing was conducted on the Arthrex 2.5 mm Tenodesis Screw in accordance with ISO 10993-1:2018.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name Arthrex 2.5mm Tenodesis Screw
Indications for Use (Describe)
The Arthrex 2.5 mm Tenodesis Screw is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Specific indications are listed below:
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
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
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
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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1
April 17, 2019
Image /page/1/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG" are written in blue, with the word "ADMINISTRATION" appearing below in a smaller font size.
Arthrex Inc. Rebecca Homan Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K183395
Trade/Device Name: Arthrex 2.5 mm Tenodesis Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC, MBI Dated: December 5, 2018 Received: December 7, 2018
Dear Rebecca 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
2
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Summary or 510(k) Statement
| Date Prepared | January 8, 2019 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Rebecca R. Homan |
| Regulatory Affairs Associate | |
| 1-239-643-5553, ext. 73429 | |
| rebecca.homan@arthrex.com | |
| Name of Device | Arthrex 2.5 mm Tenodesis Screw |
| Common Name | Screw, fixation, bone |
| Fastener, Fixation, Nondegradable, Soft Tissue | |
| Product Code | HWC; MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K063479: Arthrex 2.5 mm PushLock |
| K172612: Arthrex FiberTak DX (Reference) | |
| Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for |
| the Arthrex 2.5 mm Tenodesis Screw. | |
| Device Description | The Arthrex 2.5 mm Tenodesis Screw is a fully threaded, cannulated screw with a |
| rounded head. The screw will be offered in a 2.5 mm diameter and 6 mm length. | |
| The screw is manufactured from Polyetheretherketone (PEEK). The screw is sold | |
| as sterile, single-use. | |
| Indications for Use | The Arthrex 2.5 mm Tenodesis Screw is intended to be used for suture or tissue |
| fixation in the foot, ankle, knee, hand, wrist, elbow, and shoulder. Specific | |
| indications are listed below: | |
| Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament | |
| Reconstruction | |
| Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps | |
| Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or | |
| Capsulolabral Reconstruction | |
| 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 | |
| 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 Collateral Ligament Repair, | |
| Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band | |
| Tenodesis | |
| Technological | |
| Comparison | The Arthrex 2.5 mm Tenodesis Screw is substantially equivalent to the predicate |
| devices in which the basic design features, intended use, indications for use, | |
| material, biocompatibility, method of sterilization, packaging, and shelf-life are | |
| identical. | |
| The Arthrex 2.5 mm Tenodesis Screw 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 2.5 mm Tenodesis Screw and | |
| the predicate devices are considered minor and do not raise different questions | |
| of safety or effectiveness. | |
| Performance Data | Pull-out and failure torque/insertion torque testing were conducted to |
| demonstrate that the Arthrex 2.5 mm Tenodesis Screw performs statistically | |
| equivalent to the predicate device cleared under K063479. | |
| The Arthrex 2.5 mm Tenodesis Screw is sterilized by ethylene oxide (EO). The | |
| sterility assurance level (SAL) is 10⁻⁶. This is identical to the predicate devices | |
| cleared under K063479 and K172612. | |
| The shelf life of the Arthrex 2.5 mm Tenodesis Screw is five (5) years for the | |
| Polyetheretherketone (PEEK) material, which is identical to the predicate devices | |
| cleared under K063479 and K172612. | |
| Bacterial Endotoxins Test (BET) was performed on the Arthrex 2.5 mm Tenodesis | |
| Screw utilizing the Kinetic Chromogenic Method in accordance with ANSI/AAMI | |
| ST72:2011/(R)2016, USP , USP , EP 2.6.14. Testing was performed in | |
| compliance with US FDA good manufacturing practice (GMP) regulations 21 CFR | |
| Parts 210, 211 and 820. The testing conducted demonstrates that the Arthrex | |
| 2.5 mm Tenodesis Screw meets pyrogen limit specifications. | |
| Cytotoxicity, Sensitization, Irritaion, Genotoxicity, Systemic Toxicity, | |
| Subchronic/Subacute Toxicity, Implantation and Material Characterization testing | |
| was conducted on the Arthrex 2.5 mm Tenodesis Screw in accordance with ISO | |
| 10993-1:2018. | |
| Conclusion | The Arthrex 2.5 mm Tenodesis Screw is substantially equivalent to the predicate |
| devices in which the basic design features and intended uses are the same. Any | |
| differences between the proposed device and the predicate devices are | |
| considered minor and do not raise different questions of safety or effectiveness. | |
| Based on the indications for use, technological characteristics, and the summary | |
| of data submitted, Arthrex Inc. has determined that the Arthrex 2.5 mm | |
| Tenodesis Screw is substantially equivalent to the currently marketed predicate | |
| device. | |
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