(42 days)
K140476: Arthrex FiberTak Suture Anchor
Not Found
No
The description focuses on the mechanical design and materials of a suture anchor, with no mention of AI or ML capabilities.
Yes
The device is intended for suture or tissue fixation in various anatomical locations for the repair and reconstruction of damaged tissues, which aligns with the definition of a therapeutic device.
No
The device is a soft-tissue fixation device used for suture or tissue fixation in orthopedic repairs, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like anchors, sutures, and an inserter made of nitinol and ABS plastic. It also describes mechanical testing of pull-out strength and displacement, which are physical properties, not software metrics.
Based on the provided information, the Arthrex Fiber Tak Anchors are not an In Vitro Diagnostic (IVD) device.
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 in vivo (within the body) to repair or reconstruct tissues.
- Device Description: The description details a physical implantable device made of polyester, UHMWPE, and a disposable inserter. It is used to anchor sutures to tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The Arthrex Fiber Tak Anchors do not perform any such function. They are a surgical tool/implant.
Therefore, the Arthrex Fiber Tak Anchors are a surgical implant/device, not an IVD.
N/A
Intended Use / Indications for Use
The Arthrex FiberTak Anchors are 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 (comma separated list FDA assigned to the subject device)
MBI
Device Description
The Arthrex FiberTak Anchors are "all-suture" soft-tissue fixation devices with an expandable push-in design. 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. Once the anchor is set, the suture is passed around the soft tissue and tied in a knot to complete the repair.
The FiberTak anchor is constructed from a hollow braid of polyester with a suture component assembled through the hollow braid. The suture component can be comprised of UHWMPE or a polyblend of UHMWPE and Polyester. The anchor comes preloaded on a disposable inserter made from surgical grade nitinol and ABS plastic. The Arthrex FiberTak Anchors may be sold separately or in a kit with implantation instrumentation. The Arthrex FiberTak Anchors are provided sterile for 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)
The submitted mechanical testing demonstrates that the pull-out strength of the proposed Arthrex FiberTak Anchors meet or exceed the pull out strength of the predicate device. In addition, the pull out displacements recorded were found to meet the criteria established by the predicate devices and therefore of no clinical relevance. Furthermore, the biocompatibility and packaging/shelf life for the new suture component were reviewed and determined to be acceptable due to its similarities in material and packaging.
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.
K140476: Arthrex FiberTak Suture Anchor
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
§ 888.3040 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 19, 2015
Arthrex, Incorporated Ms. Ivette Galmzez Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
Re: K151230
Trade/Device Name: Arthrex FiberTak Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Class: Class II Product Code: MBI Dated: May 20, 2015 Received: May 21, 2015
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K151230 Device Name
Arthrex FiberTak Anchors
Indications for Use (Describe)
The Arthrex Fiber Tak Anchors are 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 of collateral ligaments, Repair of Flexor and Extensor Tendons at the PP, 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 Repart, 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
2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
Type of Use (Select one or both, as applicable)
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2.1 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
| Date Summary Prepared | June 19, 2015 |
|---|---|
| Manufacturer/Distributor/ | |
| Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Ivette Galmez |
| Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 71263 | |
| Fax: 239/598.5508 | |
| Email: igalmez@arthrex.com | |
| Trade Name | Arthrex FiberTak Anchors |
| Common Name | Soft Tissue Fixation Device |
| Product Code - | |
| Classification Name | |
| CFR | MBI |
| Fastener, fixation, nondegradable, soft tissue | |
| 21 CFR 888.3040 | |
| Predicate Device | K140476: Arthrex FiberTak Suture Anchor |
| Purpose of Submission | This special 510(k) premarket notification is submitted to obtain |
| clearance for the Arthrex FiberTak Anchors. The Arthrex FiberTak | |
| Anchors include modifications to predrilling instructions and | |
| drilling instruments, new double loaded configurations and new | |
| suture components. | |
| Device Description | The Arthrex FiberTak Anchors are "all-suture" soft-tissue fixation |
| devices with an expandable push-in design. 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. Once the anchor is set, the | |
| suture is passed around the soft tissue and tied in a knot to | |
| complete the repair. | |
| The FiberTak anchor is constructed from a hollow braid of | |
| polyester with a suture component assembled through the | |
| hollow braid. The suture component can be comprised of | |
| UHWMPE or a polyblend of UHMWPE and Polyester. The anchor | |
| comes preloaded on a disposable inserter made from surgical | |
| grade nitinol and ABS plastic. The Arthrex FiberTak Anchors may | |
| be sold separately or in a kit with implantation instrumentation. | |
| The Arthrex FiberTak Anchors are provided sterile for single use. | |
| Intended Use | The Arthrex FiberTak Anchors are 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 | |
| Substantial Equivalence | |
| Summary | The proposed Arthrex FiberTak Anchors are similar to the |
| predicate device, in which the basic design features, materials | |
| and intended uses are the same. | |
| The submitted mechanical testing demonstrates that the pull-out | |
| strength of the proposed Arthrex FiberTak Anchors meet or | |
| exceed the pull out strength of the predicate device. In addition, | |
| the pull out displacements recorded were found to meet the | |
| criteria established by the predicate devices and therefore of no | |
| clinical relevance. Furthermore, the biocompatibility and | |
| packaging/shelf life for the new suture component were | |
| reviewed and determined to be acceptable due to its similarities | |
| in material and packaging. | |
| Based on the indication for use, the technological characteristics, | |
| and the summary of data submitted, Arthrex, Inc. has | |
| determined that the Arthrex FiberTak Anchors is substantially | |
| equivalent to currently marketed predicate devices. |
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