(78 days)
The MedShape Solutions, Inc., WedgeLoc™ 2.5mm Suture Anchor with Opti-Fiber™ Sutures are intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilies Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
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
The proposed WedgeLoc™ 2.5mm Suture Anchor is an extension of sizes offered and is substantially equivalent to the WedgeLoc™ 180x Suture Anchor with Opti-Fiber™ Suture, cleared under K091202, and the predicate Arthrex PushLock™ 2.5mm Suture Anchor, cleared under K063479, in which the basic features and intended uses are the same. In addition, the technological characteristics of the WedgeLoc™ 180X and the WedgeLoc™ 2.5mm Suture Anchor are equivalent.
The provided document is a 510(k) summary for a medical device (WedgeLoc™ 2.5mm Suture Anchor with Opti-Fiber™ Suture). This type of document is a submission to the FDA (Food and Drug Administration) to demonstrate that a device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as existing products.
It is crucial to understand that 510(k) submissions, particularly for devices like suture anchors, typically do NOT include clinical studies or performance data comparing the device against acceptance criteria in the manner that AI/software as a medical device (SaMD) clearances do. For predicate-based devices, the focus is on demonstrating equivalence in design, materials, manufacturing processes, and sometimes non-clinical performance (e.g., mechanical testing) to an already cleared device. Clinical efficacy is generally inferred from the predicate device's history of safe and effective use.
Therefore, the specific information requested in the prompt, such as acceptance criteria based on accuracy metrics (sensitivity, specificity), sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details, are not relevant or applicable to this type of device submission and are not found in the provided document.
The document discusses "substantial equivalence" based on:
- Identical Intended Use: The device is indicated for the same types of procedures and anatomical locations as its predicate (K091202).
- Similar Technological Characteristics: The proposed device is an "extension of sizes offered" and shares basic features with the predicate devices (K091202 and K063479).
- Minor Differences: Any differences are considered minor and do not raise new questions of safety or effectiveness.
In summary, this document does not contain the information you've requested because it's a submission for a mechanical medical device (suture anchor) demonstrating substantial equivalence to a predicate, not a software or AI-based device requiring clinical performance validation against specific accuracy 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.