(30 days)
The SpeedScrew Knotless Fixation Device is 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 SpeedScrew Knotless Fixation Device is an implant that facilitates the attachment of tissue to bone. The SpeedScrew implant is a knotless fixation device, in other words surgical knots are not necessary for fixation of suture to tissue. The Opus SpeedScrew System consists of an implant and associated instruments for installation of the implant that is designed for specific indications in arthroscopic and orthopedic procedures.
This 510(k) summary (K100457) describes the ArthroCare Corporation Opus SpeedScrew System, which is a bone anchor (Class II per 21 CFR 888.3040, Product code: HWC). The submission is for "additional ancillary instrumentation" to be used with an existing bone anchor, the Opus SpeedScrew Knotless Fixation Device (cleared under K081893). This is crucial because this document does not present any new acceptance criteria or new studies to demonstrate device performance beyond what was established for the predicate device (K081893).
The document explicitly states: "The SpeedScrew System design and technology is substantially equivalent to the existing SpeedScrew System cleared by the Food and Drug Administration (K081893). The differences between the SpeedScrew System and the predicate system do not raise questions regarding the safety and effectiveness of the implant. The proposed system, as designed, is as safe and effective as the predicate system."
Therefore, the sections of your request related to acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to the provided K100457 document. This submission relies on the substantial equivalence to its predicate device rather than presenting new performance data.
If information on acceptance criteria and a study proving device performance is needed, it would be found in the 510(k) submission for the predicate device, K081893.
§ 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.