(41 days)
The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament
Reconstruction
• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair,
Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,
Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament
Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of
Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits,
Digital Tendon Transfers
• 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
The Arthrex Knotless SutureTak Anchor is a non-absorbable, "tap-in" suture anchor with a ribbed profile and a proximally placed external suture eyelet. The anchor is manufactured of Polyetheretherketone (PEEK) and is preloaded with Arthrex Suture and is offered preassembled on a driver. The anchor was originally cleared under K120155 for indications in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.
This document describes the Arthrex Knotless SutureTak Anchor, a medical device. Here's an analysis of its acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Pull-out Strength | Statistically equivalent to the predicate device (DePUY Mitek VERSALOK Anchor). |
| Pyrogenicity (Bacterial Endotoxin) | Device meets pyrogen limit specifications (per EP 2.6.14/USP <85>). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the pull-out test.
The provenance of the data (country of origin, retrospective/prospective) is also not specified. It is an in-vitro performance test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The study involves performance testing of the device's mechanical and biological properties, not a diagnostic or AI-driven evaluation that requires expert ground truth assessment.
4. Adjudication Method
This information is not applicable for this type of device performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a medical device (suture anchor) and not an AI-driven diagnostic tool. Therefore, an MRMC study is not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a medical device, not an algorithm.
7. Type of Ground Truth Used
For the pull-out test, the "ground truth" is established by the performance of the chosen predicate device (DePUY Mitek VERSALOK Anchor), against which the Arthrex Knotless SutureTak Anchor is compared for statistical equivalence.
For the pyrogenicity test, the "ground truth" is defined by the pyrogen limit specifications outlined in EP 2.6.14/USP <85>.
8. Sample Size for the Training Set
This information is not applicable. This is a medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no training set for this device.
{0}------------------------------------------------
Image /page/0/Picture/2 description: This image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The image is a simple text block with the address information.
Arthrex Inc. Mr. David L. Rogers Project Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945
May, 16, 2017
Re: K171020
Trade/Device Name: Arthrex Knotless SutureTak Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 4, 2017 Received: April 5, 2017
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. 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 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 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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
510(k) Summary: K171020
| Date Prepared | March 15, 2017 |
|---|---|
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | David L RogersProject Manager, Regulatory Affairs1-239-643-5553, ext. 71924david.rogers@arthrex.com |
| Name of Device | Arthrex Knotless SutureTak 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 | K063478: DePUY Mitek VERSALOK Anchor |
| Purpose ofSubmission | This traditional 510(k) premarket notification is submitted to obtain knee jointcapsule closure indications for the Arthrex Knotless SutureTak originally clearedunder K120155. |
| Device Description | The Arthrex Knotless SutureTak Anchor is a non-absorbable, "tap-in" sutureanchor with a ribbed profile and a proximally placed external suture eyelet. Theanchor is manufactured of Polyetheretherketone (PEEK) and is preloaded withArthrex Suture and is offered preassembled on a driver. The anchor wasoriginally cleared under K120155 for indications in the foot, ankle, knee, hand,wrist, elbow, shoulder, and hip. |
| Indications for Use | The Arthrex Knotless SutureTak Anchor is intended to be used for suture ortissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip.Specific indications are listed below:• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral LigamentReconstruction• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair,Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,Capsular Shift or Capsulolabral Reconstruction• Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal LigamentReconstructions, Repair/Reconstruction of collateral ligaments, Repair ofFlexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits,Digital Tendon Transfers• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles TendonRepair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, DigitalTendon Transfers, Mid-foot Reconstruction• Knee: Medial Collateral Ligament Repair, Lateral Collateral LigamentRepair, Patellar Tendon Repair, Posterior Oblique Ligament Repair,Iliotibial Band Tenodesis, Joint Capsule Closure• Hip: Capsular Repair, Acetabular Labral repair |
| Performance Data | Pull-out testing was conducted to demonstrate that the Arthrex KnotlessSutureTak Anchor performs statistically equivalent to the predicate device. |
| Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications. | |
| Conclusion | The Arthrex Knotless SutureTak Anchor is substantially equivalent to thepredicate device in which the basic design features and intended uses are thesame. Any differences between the proposed device and the predicate deviceare considered minor and do not raise questions concerning safety oreffectiveness. |
| 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. |
{3}------------------------------------------------
§ 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.