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510(k) Data Aggregation
(268 days)
The Lincotek SportLinc Syndesmosis Device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Lincotek SportLinc Syndesmosis Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
The SportLinc Syndesmosis Device is a sterile single-use device intended to stabilize syndesmotic trauma of the ankle. The subject implant assembly consists of UHMWPE suture tensioned between two low-profile titanium alloy buttons and is designed to complement plate fixation or to allow use as a standalone device. The button-suture assembly is assembled onto an inserter instrument and the pre-loaded assembly is packaged in a sterile single-use kit.
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(267 days)
The SPINELINC Anterior Cervical Implants include cervical interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C2-T1) for one or two levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. The SPINELINC Cervical Spacer Body and Anterior Cervical Spaver are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. The SPINELINC Cervical Spacer Body and Anterior Cervical Spacer are intended to be used with FDA cleared supplemental fixation. Only the SPINELINC Cervical Spacer Body is compatible with the SPINELINC Plates and Screws. When used with the SPINELINC Plate and Screws, the plate-spacer assembly takes on the indications for use of the SPINELINC Cervical Spacer Body, with the SPINELINC Plate and Screws acting as the supplemental fixation. The SPINELINC Plate and Cervical Spacer Body assembly is a stand-alone device intended for use at one or two levels of the cervical spine (C2-T1) and is to be used with three SpineLinc screws per assembly.
The SpineLinc Anterior Cervical Implant system consists of a cervical interbody fusion device, cervical plate, screws, and a locking clip, which may be implanted in various configurations to accommodate patient anatomy. The SpineLinc Anterior Cervical implant devices are offered manufactured from titanium alloy per ASTM F136 or ASTM F3001. Instrumentation is provided with the SpineLinc Anterior Cervical Implant system to facilitate implantation. Instruments are manufactured from medical grade stainless steel per ASTM F899. All subject implants and instruments are provided sterile via gamma irradiation and are provided as single use kits.
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