(28 days)
No
The device description and performance studies focus on mechanical properties and biological safety, with no mention of AI or ML.
No.
A therapeutic device is one that treats or heals a disease or condition. This device is used for suture or tissue fixation, which is a supportive and reconstructive function, not directly therapeutic.
No
The device is described as an "all-suture" soft-tissue fixation device intended for suture or tissue fixation, which indicates it is a therapeutic device, not a diagnostic one. Its purpose is to repair or reattach tissues, not to diagnose conditions.
No
The device description clearly indicates it is a physical "all-suture" soft-tissue fixation device that is impacted into a pilot hole. It is a hardware device, 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 states the device is for "suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder." This describes a surgical implant used to physically repair or stabilize tissue within the body.
- Device Description: The description details a physical "all-suture" soft-tissue fixation device that is implanted into a pilot hole and manually tensioned. This is a mechanical device used in surgery.
- Lack of Diagnostic Elements: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. IVDs are designed for testing in vitro (outside the body).
The FiberTak DX is a surgical implant, not a diagnostic device.
N/A
Intended Use / Indications for Use
The FiberTak DX 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, 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
Product codes
MBI
Device Description
The FiberTak DX is an "all-suture" soft-tissue fixation device. The anchor and connected sutures are impacted into a pilot hole. The sutures are then manually tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole.
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 testing demonstrated that the pull out displacements of the proposed FiberTak DX met the criteria established by the predicate device. Bacterial endotoxin per EP 2.6.14 / USP was conducted to demonstrate that the device meets pyrogen limit specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K140476: Arthrex FiberTak Suture Anchor
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.
0
Image /page/0/Picture/2 description: The image shows a partial view of the Department of Health & Human Services USA logo. The logo features the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern. To the right of the text are three stylized human profiles facing right, stacked one behind the other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 28, 2017
Arthrex, Inc. Ivette Galmez Senior Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K172612
Trade/Device Name: FiberTak DX Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: August 29, 2017 Received: August 31, 2017
Dear Ms. Galmez:
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. 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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Katherine D. Kavlock -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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| | | (ndications for Use (Describe) |
| | | FiberTak DX
Device Name |
| | | 510(k) Number (if known)
K172612 |
| Form Approved: OMB Not 0910-0120
Expiration Date: 06/30/2020
See PAR Statement below | DEPATMENT OF HEALTH AND HUNAN SEPVICES
ndications for Use
Food and Drug Administration | |
3
1. 510(k) Summary
| Date Prepared | September 21, 2017 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | Ivette Galmez |
| Senior Regulatory Affairs Specialist | |
| 1-239-643-5553, ext. 71263 | |
| Ivette.galmez@arthrex.com | |
| Name of Device | FiberTak DX |
| Common Name | Soft Tissue Fixation Device |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K140476: Arthrex FiberTak Suture Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is submitted to obtain clearance for a line |
| extension to the Arthrex FiberTak family cleared under K151230. | |
| Device Description | The FiberTak DX is an "all-suture" soft-tissue fixation device. The anchor and |
| connected sutures are impacted into a pilot hole. The sutures are then manually | |
| tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole. | |
| Indications for Use | The FiberTak DX 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, 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 | |
| Performance Data | Pull-out testing demonstrated that the pull out displacements of the proposed |
| FiberTak DX met the criteria established by the predicate device. | |
| Bacterial endotoxin per EP 2.6.14 / USP was conducted to demonstrate that the | |
| device meets pyrogen limit specifications. | |
| Conclusion | The FiberTak DX 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 | |
| questions concerning safety or 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 device. |