(160 days)
The Dunamis Interference Screw are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameters of 9mm or less and a length of 25mm or less are also intended for use in the following procedures: Knee (ACL Repairs, PCL Repairs, Extra-capsular repairs - Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs - Vastus medialis obliquous advancement, Iliotibial band tenodesis), Shoulder (Capsular stabilization - Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Flexor Hullucis Longus (FLH), Tendon Transfers), Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Reconstruction).
Reattachment of ligament, tendon, soft tissue, or bone, shoulder, foot, ankle, knee, elbow and hand/wrist.
The provided text describes a 510(k) premarket notification for a medical device (Dunamis Interference Screw), indicating its substantial equivalence to a predicate device. However, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or any data related to AI/human performance evaluation.
The document primarily focuses on:
- The FDA's decision regarding the 510(k) submission.
- The legal and regulatory framework for medical devices.
- The intended use and indications for the Dunamis Interference Screw.
- A comparison of the Dunamis Interference Screw to a predicate device (Smith & Nephew Biosure PK Interference Screw K083635).
- A summary of performance tests conducted (Torsional Yield Strength, Insertion and Removal Torque, Axial Push-Out Strength, Self-Tapping force, Biocompatibility, Sterilization Validation, Ethylene Oxide Residuals, Sterile Barrier Packaging performance, Aging of Sterile Medical Device), but not the specific acceptance criteria or reported performance values for these tests.
Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and study proving device meets them, as that information is not present in the provided text.
§ 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.