(69 days)
The Arthrex Tenodesis Screw is intended for arthroscopic and limited mini-open surgeries requiring soft tissue fixation to bone for repair of shoulder, hand/wrist, foot/ankle, knee, and elbow.
The Arthrex Tenodesis Screw, 5.5 mm for fixation of tissue grafts is intended for interference fixation of soft tissue grafts in the shoulder, elbow, wrist, and ankle. These surgeries will be performed by both open and arthroscopic means.
- Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
- Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Elbow: Radial Collateral Ligament Reconstruction
- Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
*This system is to be used in association with adequate post-operative immobilization.
The Arthrex Tenodesis Screw is a manually operated surgical implant intended for suture fixation in the repair of tendons and ligaments. The implant is constructed of titanium and the suture is composed of #2 braided polyester. These components are used in a wide variety of cleared medical devices and implants of this type.
This submission is for a physical medical device (Arthrex Tenodesis Screw), not a software or AI-driven device. Therefore, the questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies, which are typically relevant for AI/ML device evaluations, are not applicable in this context.
The document is a 510(k) summary for a Class II medical device, which seeks to demonstrate "substantial equivalence" to predicate devices. The review process for such devices focuses on comparing the new device's features, intended use, materials, and performance characteristics to those of already legally marketed devices.
Here's a breakdown of the relevant information from the provided text:
- Device Name: Arthrex Tenodesis Screw, 5.5 mm
- Intended Use: For arthroscopic and limited mini-open surgeries requiring soft tissue fixation to bone for repair of shoulder, hand/wrist, foot/ankle, knee, and elbow. Specifically, for interference fixation of soft tissue grafts in these areas.
- Description: Manually operated surgical implant made of titanium, with #2 braided polyester suture.
- Predicate Devices: Talon Anchor Snap-Pak by Mitek Products, RC Multisuture Bone Anchor Model 4453 by Innovasive Devices, Inc., Multitak SS Buttons by Bonutti Research, KSEA Flipptack by Karl Storz Endoscopy-America, and Acumed Suture Anchor by Acumed, Inc.
The "study that proves the device meets the acceptance criteria" in this context would typically involve mechanical testing (e.g., tensile strength, pull-out strength, fatigue testing) to demonstrate that the device performs comparably to or better than the predicate devices, and that its materials are biocompatible. However, the provided 510(k) summary does not include any specific performance data or study results.
Instead, it relies on the assertion of "substantial equivalence":
"Minor differences between the Tenodesis Screw and predicate devices do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device."
The FDA's letter confirms that they have reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market. The basis for this determination would have been the full 510(k) submission, which is not provided in its entirety here, and would contain the detailed comparisons and potentially the mechanical test data.
In summary, none of the specific questions about acceptance criteria, study design, sample size, ground truth, or expert review are directly answerable from the provided text because it is a summary for a hardware device seeking substantial equivalence, not a software/AI device proving performance against specific metrics.
§ 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.