(70 days)
The Opus Magnum2 and Opus Magnum X bone anchors with inserters are indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: Hallux valgus reconstruction Elbow: Tennis elbow repair, biceps tendon attachment Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The Opus Magnum2 and the Opus Magnum X devices are bone anchor systems with inserter handles designed for specific indications in arthroscopic and orthopedic procedures.
The provided text is a 510(k) summary for the Opus Magnum2 and Opus Magnum X Knotless Fixation Devices and does not contain information about acceptance criteria, device performance studies, or ground truth establishment. This document primarily describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.
Therefore, I cannot provide the requested information based on the input text. The text does not describe a study to prove the device meets acceptance criteria in the manner requested (e.g., using a test set, expert ground truth, or statistical measures).
The 510(k) summary states:
- "The differences between the Opus Magnum2 and the Opus Magnum X, and the predicate devices do not raise any questions regarding the safety and effectiveness of the implants."
- "Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The devices, as designed, are as safe and effective as predicate devices."
- "The expanded indications for use of these existing products are substantially equivalent to those for the Opus MiniMagnum Knotless Fixation Device originally cleared under K042584, and the Opus Magnum PI Knotless Fixation Device originally cleared under K070227."
These statements indicate that the devices were cleared based on substantial equivalence to predicate devices, not through a performance study against specific acceptance criteria for a new feature or technology that would require the kind of data you've requested.
§ 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.