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The Smith+Nephew INTELLIO 4K CCU is intended for use in diagnostic, and operative endoscopic surgical procedures, including but not limited to, for example: orthopedic procedures, laparoscopic procedures, and otolaryngology (sinuscopic) procedures when used with an appropriately indicated endoscope.

The Smith & Nephew INTELLIO 4K CCU is a part of the Smith & Nephew visualization system. It is an all-in-one 4K imaging console and LED light source designed for endoscopic surgical procedures. The CCU is compatible with the LENS 4K Camera Head. The functional system level architecture of this device demonstrates multiple functions, that includes the illumination of surgical space and capturing of raw imaging data from the camera sensors. It also processes the imaging data and transfers it to the attached monitor for display. Apart from capturing still images and video during the procedure, the device also adjusts the visualization settings (brightness, line enhancement, color saturation/hue and image zoom) and allows optional communication to a medical tablet to facilitate centralized control of all tower devices from the tablet. The device contains of a Wi-Fi board that supports communication frequency of 2.4 GHz and 5.0 GHz. The device uses a LED light engine to illuminate the surgical space. The User Interface (UI) consists of buttons and LEDs that can be accessed on the front panel, which also contain the ports for camera head connector and USB slots for medical tablet and flash drive.

The LENS 4K Camera Control Unit and LENS 4K Camera Head are used in diagnostic and operative procedures for arthroscopic and endoscopic procedures to provide illumination, visualization and capture of surgical sites within articular cavities, body cavites, hollow organs and canals. Additionally, the LENS 4K Camera Control Unit and LENS 4K Camera Head are indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.

The Smith & Nephew LENS 4K System ( 4K Camera Control Unit (CCU) and LENS 4K Camera Head), is an integrated camera/ LED light source/ image management device that provides visualization, illumination and image/video capture combined in a single console. The LENS 4K CCU works in conjunction with a camera head, appropriate light guides, couplers and endoscopes. The LENS 4K CCU will be offered in two versions, one with Wi-Fi and one without Wi-Fi. The non-Wi-Fi version does not have the ability to communicate to a tablet but captures the data to an attached USB storage device or to the Smith & Nephew 660HD-E Image Management System, which is a Class 1 device per LMB for display and sharing for display and sharing. Additionally, the LENS 4K System will also work with an optional Tablet Application, which was cleared in K190367. The Tablet application, when downloaded to a mobile device, acts as a tool to remotely capture video recordings and image files wirelessly from the LENS 4K System. The application provides the ability to view and annotate by voice or graphics or to text. Sharing of patient data from the Tablet is provided via the ability to archive to a USB storage device on the CCU, email, printing, or export to the local tablet camera roll.

The Double ENDOBUTTON Fixation Device is intended for the treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft).

The subject of this Traditional 510(k) is the Double ENDOBUTTON Fixation Device. The Smith & Nephew Double ENDOBUTTON Fixation Device is used during the healing period of osteotomies for orthopedic reconstruction and to assist in the management of fracture fixation. The device consists of three components: two stainless steel fixation devices and a UHMW polyethylene suture. This device is provided sterile, for single use only.

The Smith & Nephew MICRORAPTOR Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications: Hip • Acetabular labrum repair/reconstruction Shoulder - Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions - Biceps tenodesis - · Rotator cuff tear repairs

The MICRORAPTOR Knotless Suture Anchor consists of an anchor on an inserter fitted with a suture passer, and two accessory drills. The anchor consists of the following components: a proximal anchor body (REGENESORB or PEEK), and a non-absorbable PEEK distal anchor tip. The anchor is preloaded on a stainless steel inserter. This device is provided sterile, for single use only.

The Smith & Nephew SUTUREFIX Curved Suture Anchors are intended for the secure fixation of soft tissue to bone for the following indications: Hip • Acetabular labrum repair/reconstruction Shoulder - · Capsular stabilization - Bankart repair - Anterior shoulder instability - SLAP lesion repairs - Capsular shift or capsulolabral reconstructions - Rotator cuff tear repairs - Bicepts tenodesis

The Smith & Nephew SUTUREFIX Curved suture anchor system consists of an all suture based implant, hole preparation, and curved insertion accessory instruments. The implant will be offered in multiple suture configurations including single and double loaded suture options. The instruments will include sterile flexible drills and reusable curved drill guides and obturators.