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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.

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.

The DePuy Synthes 3.5 mm Intrapelvic Acetabular Plates are indicated for fractures of the acetabulum in adults and adolescents (greater than 12 through 21 years of age) where all growth plates within the acetabulum are fused.

The DePuy Synthes 3.5 mm Intrapelvic Acetabular System can be used to treat fractures of the acetabulum involving the anterior column, with or without involvement of the posterior column, including the quadrilateral surface (QS). The subject system is comprised of four plate types per anatomic side, left and right, (Large Extended, Small Extended, Large Standard and Small Standard) which are designed to accept the following existing cortex screws: 3.5 mm Cortex Screws, 3.5 mm Pelvic Cortex Screws, 3.5 mm Cortex Screws with low-profile head, 3.5 mm Stardrive Cortex Screws, and 4.5 mm Cortex Screws. The implants are available in a sterile configuration and are offered in Stainless Steel (SSt). In total the system is comprised of eight different plate designs. Each plate configuration consists of a long, slender suprapectineal portion that is intended to be placed along the anterior column, superior to the pelvic brim and a trapezoidal quadrilateral surface portion that is intended to be placed against the medial aspect of the posterior column, overlapping at least a portion of the quadrilateral surface. The suprapectineal portion is divided into anterior and posterior segments that are configured to mimic existing 3.5 mm reconstruction plates and a central segment, to which the quadrilateral surface portion is connected by two connecting bars.

Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with: joint destruction and/or subluxation visible on x-ray; and/or resistance to conservative treatment. Primary replacement after fracture of the radial head. Symptomatic sequelae after radial head resection. Revision following failed radial head arthroplasty.

This document is regarding the DePuy Synthes Radial Head Replacement System-MR Conditional. The Radial Head Replacement System Implant is a one-piece, stemmed radial head replacement. The radial head is available in diameters of 19, 22 and 25mm. The radial stems range from 5.5 to 8.5mm in diameter and from 21 –24mm in length. The Radial Head is manufactured from wrought CoCrMo alloy. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone. The devices in scope of the subject submission are being reviewed for MR Conditional labeling in addition to the previously cleared indications for use.

The DePuy Synthes 2.7 mm LCP Plates (Modular Mini Fragment LCP System) is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments, particularly in osteopenic bone. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

The Synthes Modular Mini Fragment LCP (Locking Compression Plate) System consists of metallic plates and screws that merge locking screw technology with conventional plating techniques. Locking screws provide the ability to create a fixed-angle construct while utilizing familiar AO plating techniques. A fixed-angle construct provides improved fixation in osteopenic bone or multifragment fractures where traditional screw purchase is compromised. The subject plates are available in various sizes in sterile configurations and are available in stainless steel and commercially pure titanium. The system also consists of implantable screws (K112583) that correspond to the subject device.

The DePuy Synthes 2.7mm VA LCP Clavicle Plate System is indicated for fixation of fractures, and nonunions of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system. The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The DePuy Synthes 2.7mm VA LCP Clavicle Plate System consists of lateral, shaft and medial plates designed for temporary fixation, correction or stabilization of clavicle bones. The subject plates are available in various sizes in both sterile and non-sterile configurations and are available in stainless steel and titanium alloy. The system also consists of non-implantable templates that correspond to the implants. Templates are intended for implant size selection and are available in non-sterile. The DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System consists of the plate types Long, Short and Button which can be used to treat simple and complex clavicle fractures including malunions, non- unions and isolated ligamentous injuries of the AC joint. The subject plates are available in three hook depths, in left- and right-side versions, in both sterile and non-sterile configurations and are available in stainless steel and titanium. The system also consists of non- implantable templates that correspond to the implants. Templates are intended for implant size selection and are available non-sterile.