(21 days)
The Arthrex Double Loaded Knotless FiberTak® Suture Anchor is intended to be used for suture (soft tissue) fixation 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 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, Joint Capsule Closure (Except Canada)
· Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair (Except Canada)
The Arthrex Double Loaded Knotless FiberTak Suture Anchor is an all-suture knotless anchor intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and hip. The Arthrex Double Loaded Knotless FiberTak Suture Anchor is a sterile, single use implant device constructed from a hollow braid of polyester (sheath) preloaded on an inserter with a double loaded suture component composed of UHMWPE and polyester.
The provided text is a 510(k) Premarket Notification from the FDA for a medical device: the "Arthrex Double Loaded Knotless FiberTak® Suture Anchor." This document describes a surgical implant and its intended uses, asserting its substantial equivalence to a previously cleared device. It does not describe an AI/machine learning device, nor does it contain information about acceptance criteria or a study that proves an AI device meets acceptance criteria.
The information you are requesting, such as ground truth, sample sizes for training/test sets, expert adjudication methods, or MRMC studies, are concepts applicable to AI/ML device evaluations, particularly for diagnostic imaging or assistive technologies. Since this document describes a physical surgical implant (a suture anchor), these concepts are not relevant to its regulatory submission.
Therefore, I cannot extract the requested information from the provided text for an AI/ML device. The document explicitly states the "Performance Data" is "Cyclic pull-out testing was conducted on the proposed devices submitted in this Special 510(k). The test data demonstrates that the proposed devices perform statistically equivalent to the predicate device. Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications." This type of testing is standard for mechanical implants, not AI.
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March 10, 2023
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Arthrex Inc. Kelsey Roberts Sr. Regulatory Affairs Specialist 1370 Creekside Blvd Naples, Florida 34108
Re: K230433
Trade/Device Name: Arthrex Double Loaded Knotless 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: February 17, 2023 Received: February 17, 2023
Dear Kelsey Roberts:
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/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.
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/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 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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-regulatoryassistance/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,
Sara S. Thompson -S
For
Laurence D. Coyne, Ph.D. 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
510(k) Number (if known) K230433
Device Name
Arthrex Double Loaded Knotless FiberTak® Suture Anchor
Indications for Use (Describe)
The Arthrex Double Loaded Knotless FiberTak Suture Anchor is intended to be used for suture (soft tissue) fixation 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 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, Joint Capsule Closure (Except Canada)
· Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair (Except Canada)
| 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 | March 7, 2023 |
|---|---|
| 510(k) Number | K230433 |
| Submitter | Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945 |
| Contact Person | Kelsey RobertsSr. Regulatory Affairs Specialist(239) 598-4302 x 72257Kelsey.Roberts@Arthrex.com |
| Trade Name | Arthrex Double Loaded Knotless FiberTak® Suture Anchor |
| Common Name | Smooth or threaded metallic bone fixation fastener |
| Product Code | MBI |
| Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener |
| Regulatory Class | Class II |
| Predicate Device | K221396: Arthrex FiberTak Suture Anchor |
| Reference Devices | K203268: Arthrex FiberTak Suture AnchorK223284: SutureLoc™ ImplantK193503: Arthrex SwiveLock Suture AnchorK193575: Arthrex SutureTapeK122374: Arthrex SutureK041553: Arthrex Suture Grafting KitK032245: Arthrex FiberTape™ FamilyK021434: Arthrex FiberWire™ USP Suture Family |
| Purpose of Submission | This Special 510(k) premarket notification is submitted as a lineextension to the Arthrex FiberTak Suture Anchors cleared viaK221396. |
| Device Description | The Arthrex Double Loaded Knotless FiberTak Suture Anchor isan all-suture knotless anchor intended to be used for fixation ofsuture (soft tissue) to bone in the shoulder, foot/ankle, knee,hand/wrist, elbow and hip. The Arthrex Double Loaded KnotlessFiberTak Suture Anchor is a sterile, single use implant deviceconstructed from a hollow braid of polyester (sheath) preloadedon an inserter with a double loaded suture componentcomposed of UHMWPE and polyester. |
| Indications for Use | The Arthrex Double Loaded Knotless FiberTak Suture Anchor isintended to be used for suture (soft tissue) fixation to bone inthe shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in thefollowing procedures:Elbow: Biceps Tendon Reattachment, Ulnar or RadialCollateral Ligament Reconstruction Shoulder: Rotator Cuff Repair, Bankart Repair, SLAPLesion Repair, Biceps Tenodesis, Acromio-ClavicularSeparation Repair, Deltoid Repair, Capsular Shift orCapsulolabral Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction,Repair/Reconstruction of collateral ligaments, Repair ofFlexor and Extensor Tendons at the PIP, DIP and MCPjoints for all digits, digital tendon transfers, CarpalLigament Reconstruction and Carpometacarpal jointarthroplasty (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, LateralCollateral Ligament Repair, Patellar Tendon Repair,Posterior Oblique Ligament Repair, Iliotibial BandTenodesis, Joint Capsule Closure (Except Canada) Hip: Capsular Repair, Acetabular Labral Repair, GlutealTendon Repair (Except Canada) |
| Performance Data | Cyclic pull-out testing was conducted on the proposed devicessubmitted in this Special 510(k). The test data demonstrates thatthe proposed devices perform statistically equivalent to thepredicate device.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted todemonstrate that the device meets pyrogen limit specifications. |
| TechnologicalComparison | The proposed devices are a line extension to the predicate deviceK221396. The proposed and predicate devices have the samebasic design, indications for use, intended use, packaging, shelf-life, biocompatibility profile, manufacturing, and sterilizationprocesses. In comparison to the predicate device, the proposedmodifications include minor dimensional changes to the sheathand repair suture. Any differences between the proposed andpredicate devices are considered minor and do not raisequestions concerning safety or effectiveness. |
| Conclusion | The Arthrex Double Loaded Knotless FiberTak Suture Anchor devices are substantially equivalent to the predicate device in which the basic design features, indications for use, intended use, materials, manufacturing, and sterilization processes are identical. Any differences between the proposed and predicate devices are considered minor and do not raise questions concerning safety or effectiveness. |
| Based on the intended use, technological characteristics, and the test data submitted, Arthrex Inc. has determined that the proposed devices are substantially 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.