(80 days)
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.
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.
The provided text is a 510(k) summary for the Arthrex FiberTak Suture Anchor. It details the device's purpose, description, and indications for use, and then discusses performance data.
However, the information provided does not contain details about a study evaluating an AI/Algorithmic device's performance against specific acceptance criteria, or an MRMC study. The "Performance Data" section solely refers to:
- Tensile testing to demonstrate the new FiberTak models perform statistically equivalent to the predicate and meet acceptance criteria for hip acetabular labral repair indications. This relates to the physical strength and function of the surgical anchor, not an AI or algorithmic medical device.
- Bacterial endotoxin testing to ensure the device meets pyrogen limit specifications. This relates to the sterility and safety of the physical device.
Therefore, I cannot fulfill your request for information regarding AI/algorithmic device acceptance criteria and study details based on the provided text. The document describes a traditional medical device (a suture anchor), not an AI-powered diagnostic or therapeutic tool.
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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
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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
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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) |
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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 modelsperform statistically equivalent to the predicate as well as meet the acceptancecriteria for hip acetabular labral repair indications.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications. |
| Conclusion | The Arthrex FiberTak Suture Anchors are substantially equivalent to the predicatedevice in which the basic design features and intended uses are the same. Anydifferences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness.Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate device. |
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§ 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.