(80 days)
No
The device description and performance studies focus on the mechanical properties and biocompatibility of a suture anchor, with no mention of AI or ML.
Yes
The device is described as a 'suture anchor' intended for 'fixation of suture (soft tissue) to bone' in various anatomical locations for procedures like 'Rotator Cuff Repair' and 'Achilles Tendon Repair', which directly address body functions and structures.
No
The device description and intended use indicate that the Arthrex FiberTak Suture Anchor is an implantable device used for surgical fixation of soft tissue to bone, not for diagnostic purposes.
No
The device description clearly states it is an 'all-suture' soft-tissue device constructed from polyester and UHWMPE, preloaded on a disposable inserter. This describes a physical, implantable medical device, not software.
Based on the provided information, 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.
- Device Description and Intended Use: The description clearly states that the Arthrex FiberTak Suture Anchor is a device intended for the fixation of suture (soft tissue) to bone during surgical procedures. It is a physical implant used within the body.
- Lack of Diagnostic Activity: There is no mention of this device being used to analyze samples, detect substances, or provide diagnostic information about a patient's condition.
Therefore, the Arthrex FiberTak Suture Anchor is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart 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 Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hip: Acetabular labral repair.
Product codes
MBI
Device Description
The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.
The anchor is constructed from a hollow braid of polyester with a single or double loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is preloaded on a disposable inserter and will be sold sterile for single use.
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
Prescription Use
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)
Tensile testing was conducted to demonstrate that the new FiberTak models perform statistically equivalent to the predicate as well as meet the acceptance criteria for hip acetabular labral repair indications.
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)
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/0 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 a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 21, 2018
Arthrex, Inc. David L. Rogers Regional Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
Re: K181769
Trade/Device Name: Arthrex 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: June 29, 2018 Received: July 3, 2018
Dear Mr. Rogers:
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/cdrl/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, 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 medical devices and radiation-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,
Laurence D. Coyne -S
For Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
PSC Publishing Services (301) 443-6740
EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Arthrex FiberTak Suture Anchor
Indications for Use (Describe)
The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart 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 Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial 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) |
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."
3
510(k) Summary
| Date Prepared | September 10, 2018 |
|---|---|
| Submitter | Arthrex Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 | |
| Contact Person | David L Rogers |
| Regional Manager, Regulatory Affairs | |
| 1-239-643-5553, ext. 71924 | |
| david.rogers@arthrex.com | |
| Name of Device | Arthrex FiberTak Suture Anchor |
| Common Name | Suture Anchor |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener |
| Regulatory Class | II |
| Predicate Device | K151230: Arthrex FiberTak Suture Anchors |
| K140855: Arthrex SutureTak Suture Anchors | |
| Purpose of | This traditional 510(k) premarket notification is submitted to obtain hip |
| Submission | acetabular labral repair indications to the Arthrex FiberTak cleared under |
| K151230, and to add additional model numbers to the Arthrex FiberTak suture | |
| anchor family. | |
| Device Description | The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended |
| to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, | |
| knee, hand/wrist, elbow, and hip. | |
| The anchor is constructed from a hollow braid of polyester with a single or | |
| double loaded suture component composed of UHWMPE or a polyblend of | |
| UHMWPE and polyester. The anchor is preloaded on a disposable inserter and | |
| will be sold sterile for single use. | |
| Indications for Use | The Arthrex FiberTak Suture Anchors are intended for fixation of suture (soft |
| tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in | |
| 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, | |
| Iliotibial Band Tenodesis | |
| Hip: Acetabular labral repair. | |
| • | |
| Performance Data | Tensile testing was conducted to demonstrate that the new FiberTak models |
| perform statistically equivalent to the predicate as well as meet the acceptance | |
| criteria for hip acetabular labral repair indications. |
Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that
the device meets pyrogen limit specifications. |
| Conclusion | The Arthrex FiberTak Suture Anchors are 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. |
4