(18 days)
The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder. Specifically, rotator cuff repairs.
The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is a fully threaded knotless suture anchor that is pre-loaded on a disposable inserter with Arthrex sutures. The anchor may be manufactured from either BioComposite (PLLA/betaTCP TriCalcium Phosphate) or PEEK (Polyether-ether-ketone). The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is provided sterile (Ethylene Oxide), single-use, and is packaged in a single-pack or 5-pack.
The provided document is an FDA 510(k) clearance letter for a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The "Performance Data" section of the 510(k) summary (page 4) states:
"Tensile (pull-out) testing was conducted on the proposed Arthrex 4.75 mm Doubled Loaded Knotless Corkscrew Suture Anchor submitted in this Special 510(k). The test data demonstrates that the proposed device performs statistically equivalent to the predicate device for the intended indications for use. Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications."
This indicates that mechanical and biocompatibility tests were performed, but no acceptance criteria or detailed study results for an AI/ML device performance are present. The document is for a physical medical device (suture anchor), not an AI/ML-driven diagnostic or therapeutic tool. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance for an AI/ML system cannot be extracted from this document.
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March 14, 2025
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Arthrex, Inc. Ruth Segall Regulatory Affairs Specialist II 1370 Creekside Boulevard Naples, Florida 34108
Re: K250526
Trade/Device Name: Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: February 21, 2025 Received: February 24, 2025
Dear Ms. Segall:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/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, 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.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CHRISTOPHER FERREIRA -S
Christopher Ferreira, MS Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor
Indications for Use (Describe)
The Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder. Specifically, rotator cuff repairs.
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 | 03/14/2025 |
|---|---|
| 510(k) Number | K250526 |
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Name: Ruth SegallTitle: Regulatory Affairs Specialist IIPhone: 239-598-4302 x 71764Email: Ruth.Segall@arthrex.com |
| Trade Name | Arthrex 4.75mm Double Loaded Knotless Corkscrew®Suture Anchor |
| Common Name | Suture Anchor |
| Product Code | MAI, MBI |
| Classification Name | 21 CFR 888.3030: Single/multiple component metallicbone fixation appliances and accessories21 CFR 888.3040: Smooth or threaded metallic bonefixation fastener |
| Regulatory Class | Class II |
| Primary Predicate Device | K173788: Arthrex Corkscrew FT |
| Additional Predicate Devices | N/A |
| Reference Devices | K193157: Arthrex 3.9 mm Corkscrew Suture AnchorK230433: Arthrex Double Loaded Knotless FiberTak®Suture Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is submittedto obtain clearance for the Arthrex 4.75 mm DoubleLoaded Knotless Corkscrew Suture Anchor as a lineextension to the Arthrex Corkscrew Suture Anchorscleared via K173788. |
| Device Description | The Arthrex 4.75 mm Double Loaded KnotlessCorkscrew Suture Anchor is a fully threaded knotlesssuture anchor that is pre-loaded on a disposableinserter with Arthrex sutures. The anchor may bemanufactured from either BioComposite (PLLA/βTCPTriCalcium Phosphate) or PEEK (Polyether-ether-ketone) |
| The Arthrex 4.75 mm Double Loaded KnotlessCorkscrew Suture Anchor is provided sterile (EthyleneOxide), single-use, and is packaged in a single-pack or 5-pack. | |
| Indications for Use | The Arthrex 4.75 mm Double Loaded KnotlessCorkscrew Suture Anchor is intended for fixation ofsuture (soft tissue) to bone in the shoulder. Specifically,rotator cuff repairs. |
| Performance Data | Tensile (pull-out) testing was conducted on theproposed Arthrex 4.75 mm Doubled Loaded KnotlessCorkscrew Suture Anchor submitted in this Special510(k). The test data demonstrates that the proposeddevice performs statistically equivalent to the predicatedevice for the intended indications for use.Bacterial endotoxin per EP 2.6.14/USP <85> wasconducted to demonstrate that the device meetspyrogen limit specifications. |
| Technological and PredicateComparison | The Arthrex 4.75 mm Double Loaded KnotlessCorkscrew Suture Anchor are a line extension to thepredicate device K173788. The indications for use forthe subject device are a subset of the indications of thepredicate device. The proposed and predicate deviceshave identical basic design, indications for use, intendeduse, packaging, shelf-life, biocompatibility profile,manufacturing, and sterilization processes. Incomparison to the predicate device, the proposedmodifications include minor modifications to themethod of fixation of the suture to the anchor, creatinga closed loop within the anchor body, and the pre-loaded suture. Any differences between the proposedand predicate devices are considered minor and do notraise any questions concerning safety or effectiveness. |
| Conclusion | The Arthrex 4.75 mm Double Loaded KnotlessCorkscrew Suture Anchor is substantially equivalent tothe predicate devices in which the basic design featuresand intended use are identical. The proposed device isindicated for a subset of the indications for use of the |
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§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.