(83 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of the implant system, with no mention of AI or ML.
No.
The device is an implant system used for fixation of suture to bone during various surgical procedures, primarily for repair and reconstruction of ligaments and tendons. It is a surgical implant rather than a device that provides therapeutic treatment itself.
No
The device is an implant system used for the fixation of soft tissue to bone in various surgical procedures, not for diagnosing conditions.
No
The device description explicitly states that the system consists of a physical implant (Titanium alloy button) and associated hardware (inserter, suture threader, nitinol loop, sutures, and instrumentation). This is a hardware-based medical device, not software-only.
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 surgical implant system for fixing soft tissue to bone in various anatomical locations. This is a therapeutic and structural function within the body.
- Device Description: The device is described as an implant system consisting of a button, sutures, and instrumentation. This aligns with a surgical device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information about a patient's health status or condition based on such analysis. IVDs are designed to perform these types of tests.
Therefore, the Knotless TensionTight Button Implant System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Knotless TensionTight Button Implant System is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip the following procedures:
· 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 of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• 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, Illiotibial Band Tenodesis
· Hip: Acetabular Labral Repair
Product codes
MBI
Device Description
The Knotless TensionTight Button Implant System consists of an oblong Titanium alloy button with locking trap door preloaded on an inserter with a suture threader and nitinol loop and two Arthrex #5 FiberLink sutures (K122374). The button and sutures are packaged with class I exempt instrumentation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder, foot/ankle, knee, hand/wrist, elbow, and hip
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
Static and dynamic pull-out testing of the proposed Knotless TensionTight Button Implant System met the criteria established by the predicate device (K181769). Biocompatibility testing per ISO 10993-1:2009 demonstrated passing results. Bacterial endotoxin per EP 2.6.14 / USP was conducted to demonstrate that the device meets pyrogen limit specifications
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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November 17, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Arthrex Inc. Jessica Singelais Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K202444
Trade/Device Name: Knotless TensionTight Button Implant System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: October 16, 2020 Received: October 20, 2020
Dear Ms. Singelais:
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. 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) K202444
Device Name
Knotless TensionTight Button Implant System
Indications for Use (Describe)
The Knotless TensionTight Button Implant System is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip the following procedures:
· 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 of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• 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, Illiotibial Band Tenodesis
· Hip: Acetabular Labral Repair
| 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 | October 16, 2020 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Jessica Singelais |
| Regulatory Affairs Specialist | |
| 1-239-598-4302, ext. 73091 | |
| Jessica.singelais@arthrex.com | |
| Name of Device | Knotless TensionTight Button Implant System |
| Common Name | Fastener, Fixation, Nondegradable, Soft Tissue |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | Class II |
| Predicate Device | K181769: Arthrex FiberTak Suture Anchor |
| K123341: Arthrex Proximal Biceps Button | |
| K061863: Arthrex PushLock Suture Anchor | |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for the |
| Knotless TensionTight Button Implant System. | |
| Device Description | The Knotless TensionTight Button Implant System consists of an oblong Titanium alloy |
| button with locking trap door preloaded on an inserter with a suture threader and | |
| nitinol loop and two Arthrex #5 FiberLink sutures (K122374). The button and sutures | |
| are packaged with class I exempt instrumentation. | |
| Indications for Use | The Knotless TensionTight Button Implant System is intended for fixation of suture |
| (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip the | |
| following procedures: | |
| • 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, Repair/Reconstruction of | |
| collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and | |
| MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction | |
| and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) | |
| • 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, Illiotibial Band | |
| Tenodesis | |
| • Hip: Acetabular Labral Repair | |
| Performance Data | Static and dynamic pull-out testing of the proposed Knotless TensionTight Button |
| Implant System met the criteria established by the predicate device (K181769). | |
| Biocompatibility testing per ISO 10993-1:2009 demonstrated passing results. | |
| Bacterial endotoxin per EP 2.6.14 / USP was conducted to demonstrate that the | |
| device meets pyrogen limit specifications | |
| Comparison Summary | |
| of Technological | |
| Characteristics and | |
| Modifications | |
| Proposed | The proposed and predicate devices (K123341) have the same technological |
| characteristics (base material, sterilization, shelf life, and packaging). In comparison | |
| to the predicate (K123341), the proposed device is manufactured from titanium alloy | |
| Ti-6Al-4V per ASTM F2885 and features a trap door locking mechanism. The proposed | |
| device has the same indications for use as the predicate device (K181769). Any | |
| differences between the proposed device and the predicate devices are considered | |
| minor and do not raise questions concerning safety or effectiveness | |
| Conclusion | The Knotless TensionTight Button Implant System is substantially equivalent to the |
| predicate devices in which the basic design features, sterility, shelf life and packaging | |
| configuration, and intended uses are the same. |
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 devices. |
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