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The Synthes Graphic Case & Tray System are used in healthcare facilities to store, organize, and transport DePuy Synthes orthopedic instruments and implants during sterilization and surgical procedures. The Synthes Graphic Case & Tray System are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, FDA-cleared sterile barrier (e.g., wraps or reusable rigid sterilization containers). The Synthes Graphic Case & Tray System is validated for use with orthopedic medical devices including lumen (cannulated) devices and mated surface devices (devices or device configurations with conjoined surfaces which meet, touch or unite). Compatible instrument and implant materials include intrinsically stable metals, composites, thermoplastics and thermosetting polymers with constant use temperatures above 135°C. The Synthes Graphic Case & Tray System were validated for a maximum load of 25 lbs (case + contents+ lid+ weight of sterile barrier wrap). Method: Steam Sterilization (Moist Heat Sterilization) Cycle Pre-vacuum Temperature: 270 °F (132 °C) Exposure time: 4 minutes Minimum Drying time: 20 minutes

The Synthes Graphic Case and Tray System is a modular, reusable case and tray system intended for use in health care facilities for the purpose of containing medical devices for sterilization. It is composed of multiple pieces, designed to be integrated into a single unit that contains and protects instruments and implants during sterilization and transport. All components are perforated for steam penetration.

SynthVISION is a software application that can be used within a web -browser to process and view DICOM and non-DICOM image data and associated medical in the day-to-day diagnostic activities of medical imaging professionals and those involved in the care of a patient.

SynthVISION is a medical imaging viewing software used with off-the-shelf workstation hardware and web browsers for the 2D & 3D diagnostic visualization of DICOM and non-DICOM medical images by intended users such as trained radiologists, technologists and all others involved in the patient's care. SynthVISION consists of configurable software-only modules that display and process DICOM and non-DICOM images and associated medical information to aid in the day-to-day operations and workflow of imaging healthcare professionals, clinicians and other healthcare practitioners. SynthVISION has the following primary features and functions - - Zero-footprint medical image upload, transfer, and display of medical images between facilities - Easy access to images for all participants in the healthcare process, including radiologists, physicians, nurses and others who participate in patient care - Serves as information and data management system for DICOM and non-DICOM medical images - Industry-standard tools for image manipulation, annotation and measurement ● - Metadata information and orientation labels display - . Advanced image manipulation functions like view synchronization across series, MIP and MPR - Advanced image processing filters - Encrypted transmission of medical images through secured networks - Encrypted storage of medical images - . HIPAA-compliant data management, including centralized storage of user activities via audit trails.

The DePuy Synthes Retrograde Femoral Nail Advanced System is intended to stabilize fractures of the distal femur and the femoral shaft, including: - Supracondylar fractures, including those with intra-articular extension - Combination of ipsilateral condylar and diaphyseal fractures - Ipsilateral femur/tibia fractures - Femoral fractures in multiple trauma patients - Periprosthetic fractures - Fractures in the morbidly obese - Fractures in osteoporotic bone - Impending pathologic fractures - Malunions and nonunions

The DePuy Synthes Retrograde Femoral Nail Advanced System was developed to address challenges associated with treating distal femur fractures with intramedullary nails. The modular system incorporates several components to a variety of fracture patterns including those in the presence of previously implanted devices such as the femoral components of a total knee arthroplasty (periprosthetic). The nailing implants are available in two distal bend configurations which enable standard and periprosthetic entry points for the insertion of the femur. The nailing system implants are manufactured from titanium alloys, stainless steel and polyethylene and are provided in a range of dimensions.

Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated; and with the VELYS Spine System as well as the with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which: • the use of EXPEDIUM, VIPER, SYMPHONY OCT and the TriALTIS Spine System is indicated, - · the use of stereotactic surgery may be appropriate, and · reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System. The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™, VIPER™, SYMPHONY™ OCT and TriALTISTM screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation Enabled Instruments also include the CROSSNAV™ Adaptor to facilitate navigation of the Navigation Enabled Instruments with the VELYS Spine System. Navigation of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine as well as the Medtronic StealthStation navigation system and associated tracking arrays.

Robotic Integration Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Robotic Integration Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated and with the VELYS Robotic-Assisted Solution for Spine. The Robotic Integration Instruments are indicated for use in surgical spinal procedures, in which: · the use of EXPEDIUM. VIPER. TriALTIS and SYMPHONY OCT is indicated. - · the use of stereotactic surgery may be appropriate, and · reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (eg. CT or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion. The Robotic Integration Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System. The Robotic Integration Instruments used in conjunction with the SYMPHONY OCT system are intended to support indicated cervical and thoracic polyaxial screw placement only.

Robotic Integration Instruments are reusable instruments used for the preparation and placement of DePuy Synthes screws (EXPEDIUM, VIPER, TriALTIS and SYMPHONY OCT), in either open or percutaneous procedures. The Robotic Integration instruments consist of a collection of Array Sleeves. Access Guides, Drills, Taps and Screwdrivers as well as various accessories and are designed for robotic assisted, navigated and nonnavigated use. They can be operated manually or under power. Navigation and Robotic Guidance of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine and associated and compatible VELYS Spine Instrument Arrays. The Core Instrument is a Navigation Ready Instrument, navigation of this instrument is achieved using a Universal Navigation Adaptor Set (UNAS) Navigation Ring and compatible VELYS Spine Instrument Arrays.

TELIGEN Navigation Ready Instruments: The TELIGEN System is indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the surgical area of the spine. The TELIGEN Access Probe and TELIGEN Clear are Navigation Ready Instruments and when used with the compatible Universal Navigation Adaptor Set (UNAS) are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. The navigation feature is used in surgical spinal procedures, in which: · the use of stereotactic surgery may be appropriate, and · reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays. These procedures include but are not limited to spinal fusion. TELIGEN Clear and TELIGEN Access Probe, when used with UNAS Navigation Rings, can be precalibrated with: - · the VELYS Spine System using the VELYS Spine Instrument Arrays, - · the Brainlab Navigation System using the UNAS Arrays. TELIGEN Access Probe in conjunction with UNAS can also be manually calibrated with other navigation systems, using tracking arrays supplied by the navigation system manufacturer. The TELIGEN Access Probe is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for location and identification during surgery. Discectomy Navigation Ready Instruments: The Discectorny Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures to facilitate disc space preparation, including discectomy or bony resection. These are indicated for use in surgical spinal procedures, in which: - · the use of stereotactic surgery may be appropriate, and · reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data-based model of the anatomy using a navigation system and associated navigation arrays. These procedures include but are not limited to spinal fusion. The Discectomy Navigation Ready Instruments can be pre-calibrated with the VELYS Spine System (only for TELIGEN Graft Delivery Cannula and the curettes) as well as the Brainlab Navigation System.Universal Navigation Adaptor Set: The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which: · the use of stereotactic surgery may be appropriate, and · reference to a rigid anatomical structure, such as the pelvis or a vertebrae can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy using a navigation system and associated tracking arrays. These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instruments, when used with UNAS, can be: · pre-calibrated with the VELYS Spine System using VELYS Spine System Instrument Arrays, - · pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.

TELIGEN Navigation Ready Instruments TELIGEN Navigation Ready Instruments are part of TELIGEN Kits. The TELIGEN Kits are sterile, single use kits intended for use in surgical spinal procedures allowing for access, visualization, discectomy, graft delivery, navigation and peripheral motor nerve stimulation. The TELIGEN Kits include a camera, ports and port holder, TELIGEN Clear, a soft tissue retractor, a port cutter cartridge and bone graft delivery instruments. Additionally, the TELIGEN Procedure Kit Pro includes an Access Probe. TELIGEN Access Probe and TELIGEN Clear are part of the DePuy Synthes Navigation Ready Instruments Portfolio and are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling. Discectomy Navigation Ready Instruments The Discectomy Navigation Ready Instruments are reusable instruments used for disc space preparation, including discectomy or bony resection. These instruments are designed for navigated and non-navigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS) and associated navigation arrays. For further details on UNAS, refer to the UNAS labeling. Universal Navigation Adaptor Set The Universal Navigation Adaptor Set (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments. The UNAS can only be used with the VELYS Spine System as well as Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes: - Brainlab compatible UNAS Navigation Arrays, - . VELYS Spine/Brainlab compatible Navigation Rings and - Medtronic compatible Navigation Ring ST. ● The Navigation Rings and Navigation Ring ST mate with compatible DePuy Synthes Navigation Ready Instruments. These instruments include implant site preparation and implant insertion instruments as well as access and discectomy instruments. When the VELYS Spine/Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument: - . VELYS Spine System Instrument Array can be attached and the instrument can be used with the VELYS Spine System as pre-calibrated instrument, or - . UNAS Navigation Array can be attached and the instrument can be used with the Brainlab Navigation System as either a manually calibrated and/or pre-calibrated instrument. When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation Navigation System.

The DePuy Synthes MatrixSTERNUM Fixation System is indicated for use in adults with normal bone quality. MatrixSTERNUM Sternal Body Plates are indicated for internal fixation of bone discontinuities following sternotomy. MatrixSTERNUM Thoracotomy Plates are indicated for internal fixation of bone and/or cartilage discontinuities following thoracotomy.

The DePuy Synthes MatrixSTERNUM Fixation System consists of two families of plates, namely the MatrixSTERNUM Sternal Body Plates and MatrixSTERNUM Thoracotomy Plates, and two families of screws, namely the MatrixSTERNUM Self-Drilling Locking and Non-Locking Screws. The DePuy Synthes MatrixSTERNUM Fixation System is intended for the stabilization and fixation of bones in the anterior chest wall. The subject plates are available in different shapes and sizes and are made from Titanium Alloy or commercially pure Titanium. The system also consists of non-implantable dedicated use screw guides, a screw guide handle, trays and modules, as well as general use instruments to be used as accessories with the subject implants.

DePuy Synthes VOLT™ Mini Fragment Plating System: The VOLT™ Mini Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size. The VOLT™ Mini Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation. If used in the femur, tibia, humerus, patella, or pelvis the VOLT™ Mini Fragment Plating System can only be used for non-load bearing stabilization and reduction. DePuy Synthes VOLT™ Small Fragment Plating System: The VOLT Small Fragment Plating System is indicated for internal fracture fixation of bones and bone fragments of the appendicular skeleton appropriate for the implant size. The VOLT Small Fragment Plating System is intended for adults and both children (2-12 years) and adolescents (12-21 years) in which growth plates (physes) have fused or in which unfused growth plates will not be compromised by fixation. If used in the femur the VOLT Small Fragment Plating System can only be used for non-load bearing stabilization and reduction.

DePuy Synthes VOLT™ Mini Fragment Plating System The DePuy Synthes VOLT™ Mini Fragment Plating System is a family of implantable devices, consisting of non-contoured, non-anatomic straight and shaped plates (Adaption, Adaption Combi, Compact Straight, Straight Condylar, Hook, T-Plate, Tine, Y-Plate and Triangle), with variable angle screw holes, and two screw types (cortex and locking screws). The system is available in three sizes; 2.0mm, 2.4mm and 2.7mm. The Triangle Plate is available in 2.4mm and 2.7mm sizes only. The plates of this system are available in Stainless Steel and Commercially Pure Titanium, whilst the corresponding screws are available in Stainless Steel and Titanium Alloy (TAV) respectively. Plates and screws within the VOLT™ Mini Fragment Plating System are available either sterile or non-sterile and are single-use only. DePuy Synthes VOLT™ Small Fragment Plating System The DePuy Synthes VOLT™ Small Fragment Plating System is a family of implantable devices consisting of 3.5mm non-contoured, non-anatomic plates with variable angle screw holes. and 3.5mm locking, 3.5mm cortex, and 4.0mm cancellous screws. The plates of this system are available in Stainless Steel and Titanium, whilst the corresponding screws are available in Stainless Steel and Titanium Alloy (TAV). Plates and screws within the VOLT™ Small Fragment Plating System are available either sterile or non-sterile and are single-use only

The MAXFRAME AUTOSTRUT System is indicated for the following treatments in adults, and in both children (3-12) and adolescents (12-21) in which growth plates have fused or will not be crossed with hardware: - · fracture fixation (open and closed) - · pseudoarthrosis of long bones - · limb lengthening (epiphyseal or metaphyseal distraction) - · joint arthrodesis - · infected fractures or nonunions - correction of bony or soft tissue deformities - · correction of segmental defects.

The MAXFRAME AUTOSTRUT System is comprised of a control system, software, and six length-adjustable struts powered by a motor. The devices are used in conjunction with the DePuy Synthes MAXFRAME multi axial correction system (K161417), including all its parts and software, except that the MAXFRAME struts are substituted with the MAXFRAME AUTOSTRUT Hexapod Struts. This submission is solely for the clearance of a sterile version of the MAXFRAME AUTOSTRUT Hexapod Struts. The MAXFRAME AUTOSTRUT Hexapod Struts are provided sterile and are comprised of telescopic rods made of stainless steel and aluminum and a motor adapter made from polymeric material. The MAXFRAME AUTOSTRUT Hexapod Struts are available in three lengths - short, medium, and long. The MAXFRAME AUTOSTRUT Control System and Software have been cleared under K202810.