(268 days)
The ICONN Campbell Interference Screw System is intended for fixation of tissue, including ligament or tendon to bone for the following indications:
Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tenodesis. Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis.
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist, Lateral Epicondylitis repair.
The ICONN Campbell Interference Screws (various part numbers) are sterile (gamma irradiation), single use implantable devices available in two materials: Solvay's Zeniva®ZA-600L polyetheretherketone (PEEK) or Ti 6Al-4 ELI (Grade 23) and is intended for fixation of tissue, including ligament or tendon to bone. The screws are available in multiple sizes ranging from diameters of Ø6mm - Ø12mm in 1mm increments. The Ø6mm screw is available only in 20mm long, the Ø7mm - Ø10mm screws are available in 20mm and 25mm lengths, and the Ø11mm and Ø12mm screws are available in 25mm lengths only.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary for the ICONN Campbell Interference Screw:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | ||
| Axial Pullout Strength (after cyclic loading) | Similar or better than the predicate device (Arthrex PEEK Interference Screw) OR within acceptable ranges for the intended use. | Performed similarly or better than the predicate OR within acceptable ranges for the intended use. |
| Displacement during Cyclic Loading | Similar or better than the predicate device (Arthrex PEEK Interference Screw) OR within acceptable ranges for the intended use. | Performed similarly or better than the predicate OR within acceptable ranges for the intended use. |
| Torsional Properties (Insertion Testing) | Device can be safely implanted. | Testing results showed that the device can be safely implanted. |
| Driving Torque (Insertion Testing) | Device can be safely implanted. | Testing results showed that the device can be safely implanted. |
| Biocompatibility | ||
| Cytotoxicity | Met acceptance criteria (in accordance with ISO 10993-1:2009/(R)2013). | Met acceptance criteria. |
| Irritation | Met acceptance criteria (in accordance with ISO 10993-1:2009/(R)2013). | Met acceptance criteria. |
| Sensitization | Met acceptance criteria (in accordance with ISO 10993-1:2009/(R)2013). | Met acceptance criteria. |
| Endotoxin (LAL Test) |
§ 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.