(54 days)
The Titan Ti Suture Anchor System is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist and elbow in the following procedures:
- Shoulder· Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tendodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction;
- Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament/Tendon Repair, Bunionectomy;
- Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodosis;
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction,
- Elbow Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair;
- Hip: Capsular Repair, Acetabular Labral Repair
The ArthroCare Titan Ti Suture Anchor is a fully-threaded, self-tapping, titanium corkscrew shape anchor available in 5.5mm and 6.5mm diameter sizes. The suture anchor comes preconfigured with Magnum Wire® sutures and is mounted on a disposable delivery driver The device is supplied sterile and is available with or without needles. The optional Titan instruments are used to facilitate implantation and removal of the Titan Ti Suture Anchor
This document is a 510(k) summary for the ArthroCare Corporation Titan™ Ti Suture Anchor System. It describes a medical device, its intended use, and its substantial equivalence to previously cleared predicate devices.
Based on the provided text, the device is a "Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040)" and the submission is for a modification to an existing device, specifically the addition of polyethylene tubing to improve shaft design.
Crucially, this document does not describe a study to prove the device meets acceptance criteria. Instead, it is a regulatory submission for a medical device seeking clearance based on substantial equivalence to predicate devices. This type of submission generally does not include detailed studies with acceptance criteria, sample sizes, expert ground truth, or MRMC comparative effectiveness specific to the current submission's modification. The FDA's clearance is based on the argument that the modification (the addition of polyethylene tubing) does not raise new questions regarding safety and effectiveness, implying that the performance characteristics of the device remain largely consistent with the predicate.
Therefore, I cannot provide the requested information from the given text as the information is not present. The document focuses on regulatory clearance, not on a detailed performance study as would be conducted for a new or significantly modified device requiring extensive clinical or analytical validation.
§ 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.