(24 days)
No
The summary describes a mechanical suture anchor and does not mention any software, algorithms, or AI/ML capabilities.
No
The FiberTak® Suture Anchors are described as all-suture anchors intended for soft tissue to bone fixation, used in various anatomical locations for repair and reconstruction, rather than directly treating a disease or condition.
No
The device is described as a suture anchor intended for tissue fixation, which is a therapeutic function, not a diagnostic one.
No
The device description clearly states "The FiberTak® Suture Anchors are all-suture anchors intended to be used for soft tissue to bone fixation," indicating a physical, hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip." This describes a surgical implant used to physically attach tissue to bone.
- Device Description: The description reinforces this, stating it's an "all-suture anchor intended to be used for soft tissue to bone fixation."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve tests performed in vitro (outside the body).
- Performance Studies: The performance studies described (ultimate load testing, cyclic displacement, bacterial endotoxin) are related to the mechanical and biological safety of an implantable device, not the analytical or clinical performance of a diagnostic test.
In summary, the FiberTak® Suture Anchors are a surgical implant used for mechanical fixation within the body, which is distinct from the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The FiberTak® Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
The FiberTak® Suture Anchors are intended for the following indications:
• 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, Iliotibial Band Tenodesis, Joint Capsule Closure
• Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.
Product codes
MBI
Device Description
The FiberTak® Suture Anchors are all-suture anchors intended to be used for soft tissue to bone fixation.
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, shoulder, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Ultimate load testing and cyclic displacement was performed on the subject device to demonstrate that the differences do not negatively impact mechanical strength.
Bacterial endotoxin per USP was conducted to demonstrate that the device meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K230568 Arthrex FiberTak® Suture Anchor
Reference Device(s)
K203268 Arthrex Knotless FiberTak®
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
June 1, 2023
Image /page/0/Picture/1 description: The image contains 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, and then the word "ADMINISTRATION" in a smaller font size below.
Arthrex Inc. Erikka Edwardsen Regulatory Affairs Principal Specialist 1370 Creekside Boulevard Naples. Florida 34108-1945
Re: K231330
Trade/Device Name: FiberTak® Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 5, 2023 Received: May 8, 2023
Dear Ms. Edwardsen:
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 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,
Yu-chieh Chiu -S
Yu-Chieh Chiu, 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
2
Indications for Use
510(k) Number (if known) K231330
Device Name FiberTak® Suture Anchor
Indications for Use (Describe)
The FiberTak® Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
The FiberTak® Suture Anchors are intended for the following indications:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromo-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, Iliotibial Band Tenodesis, Joint Capsule Closure
· Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon 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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3
510(k) Summary
| Date Prepared | May 5, 2023 |
|---|---|
| 510(k) Number | K231330 |
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Erikka Edwardsen |
| Regulatory Affairs Principal Specialist | |
| 1-239-643-5553, ext. 70422 | |
| rikka.edwardsen@arthrex.com | |
| Name of Device | FiberTak® Suture Anchor |
| 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 | II |
| Predicate Device | K230568 Arthrex FiberTak® Suture Anchor |
| Reference Device | K203268 Arthrex Knotless FiberTak® |
| Purpose of | |
| Submission | This Special 510(k) premarket notification is submitted to obtain clearance for |
| two (2) new FiberTak® Suture Anchors as a line extension to previously cleared | |
| Arthrex FiberTak® devices (K230568) | |
| Device | |
| Description | The FiberTak® Suture Anchors are all-suture anchors intended to be used for soft |
| tissue to bone fixation. | |
| Indications for | |
| Use | The FiberTak® Suture Anchors are intended to be used for suture or tissue |
| fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. | |
| The FiberTak® Suture Anchors are intended for the following indications: | |
| • 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, Iliotibial Band | |
| Tenodesis, Joint Capsule Closure | |
| • Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair. |
4
| Summary of
Technological
Characteristics | The proposed devices have similar technological characteristics as the predicate
devices. The subject device is comprised of multiple sutures manufactured using
the same materials as the predicate. |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data | Ultimate load testing and cyclic displacement was performed on the subject
device to demonstrate that the differences do not negatively impact mechanical
strength.
Bacterial endotoxin per USP was conducted to demonstrate that the device
meets pyrogen limit specifications. |
| Conclusion | The FiberTak® Suture Anchors are substantially equivalent to the predicate
devices in which the basic design features, intended use and surgical technique
are the same. Any differences between the subject device and the predicate
devices do not raised questions concerning safety and effectiveness.
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. |