(69 days)
The Pre-Threaded EndoButton is intended to be used to fixate suture during the repair of tendon and ligament fixation. The Pre-Threaded EndoButton is used for fixation of tendons and ligaments during orthopedic reconstructive procedures such as Anterior Cruciate Ligament (ACL) Reconstruction.
The Pre-Threaded EndoButton is a titanium suture retention device packaged sterile, pre-threaded with polyester tape and polyester suture. The construct is used to fixate tendons and ligaments during orthopedic procedures, specifically during ACL reconstructions.
This document is a 510(k) summary for the Pre-Threaded EndoButton and does not contain information about acceptance criteria or a study proving its performance. The document focuses on demonstrating substantial equivalence to previously cleared devices.
Therefore, I cannot provide a response to your request as the necessary information is not present in the provided text.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.