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The TriALTIS™ System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusions in skeletally mature patients. When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis, and congenital scoliosis. Additionally, the TriALTIS™ System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The TriALTIS™ Spine System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws and connectors) to link the longitudinal components for additional stability. The subject TriALTIS™ System implants are comprised of Titanium alloy conforming to ASTM F136 and Nitinol conforming to ASTM F2063.

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 with the Brainlab Navigation System and the Medtronic StealthStation® Navigation 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 aquired image (CT, MR, 2D fluoroscopic image or 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. Universal Navigation Adaptor Set (UNAS): 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 vertebrac can be identified relative to the acquired image (CT. MR, 2D fluoroscopic image or 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 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. Via the CROSSNAV Adaptor, the UNAS Navigation Arrays are also compatible with DePuy Synthes Navigation Enabled Instruments indicated for use with the Brainlab Navigation System.

Navigation Enabled Instruments (CROSSNAV™ Instruments) are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™, VIPER™, SYMPHONY™ OCT and TriALTIS™ 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 as well as with the Brainlab Navigation System. Navigation of these instruments is achieved using the VELYS Spine System as well as Brainlab Navigation System and the Medtronic StealthStation Navigation System and their associated tracking arrays. Universal Navigation Adaptor Set (UNAS) 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 as well as the Navigation Enabled 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: - a VELYS Spine Instrument Array can be attached and the instrument can be used with the VELYS Spine System as a pre-calibrated instrument, or - . a 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. Via the CROSSNAV Adaptor, the UNAS Navigation Arrays are also compatible with DePuy Synthes Navigation Enabled Instruments indicated for use with the Brainlab Navigation System. 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 TriALTIS™ System is intended to provide immobilization of spinal segments in sketally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat spinal deformities (i.e, scoliosis, or lordosis) including adolescent idiopathic scoliosis, and congenital scoliosis. Additionally, the TriALTIS™ System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The TriALTIST™ Spine System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws and connectors) to link the longitudinal components for addity. The subject TriALTIS™ Spine System implant components are comprised of Titanium alloy conforming to ASTM F136.

The TriALTIS™ Spine System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities of the thoracic, lumbar and sacral spine. The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat spinal deformities (i.e, scoliosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis. Additionally, the TriALTIS™ System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The TriALTIS™ Spine System is a posterior spinal fixation system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) to link the longitudinal components for additional stability. The TriALTIS™ System implant components are comprised of Titanium alloy conforming to ASTM F136, and Cobalt-Chromium-Molybdenum alloy conforming to ASTM F1537.

The SYMPHONY OCT System is intended to provide immobilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical unction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3): - · Traumatic spinal fractures and/or traumatic dislocations; - Instability or deformity; - · Failed previous fusions (e.g. pseudarthrosis); - · Tumors involving the cervical/thoracic spine; · Degenerative disease, including intractable radiculopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and · Degenerative disease of the facets with instability. The SYMPHONY OCT System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The SYMPHONY OCT System is compatible with occipital fusion components (plates, rods and clamps) from the SYNAPSE Occipital-Cervical-Thoracic (OCT) System and the MOUNTAINEER OCT Spinal System. Additionally, the SYMPHONY OCT System is compatible with SYNAPSE OCT System hooks and rods. The SONGER Wire/Cable System may be used with the SYMPHONY OCT System to allow for wire/cable attachment to the posterior cervical spine. The SYMPHONY OCT System may be connected to the EXPEDIUM® Spine System and VIPER® System using connectors and tapered rods. The SYMPHONY OCT System can also be linked to the USS Spinal System and MATRIX Spine System using connectors and tapered rods.

The SYMPHONY OCT System is a posterior system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the craniocervical junction, the cervical spine (C1 to C7) and the upper thoracic spine (T1-T3). The system is composed of multiple components to allow the surgeon to build an implant s anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) with optional transverse connectors) to link the longitudinal components for additional stability.

The GRYPHON™ Flex Knotless Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures: Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction, Superior Capsule Reconstruction (Glenoid Only) Hip: Acetabular Labral Repair Knee: MCL, LCL, Iliotibial Band Tenodesis Foot/Ankle: Lateral Stabilization, Medial Stabilization

The proposed GRYPHON™ Flex Knotless PEEK and BIOCOMPOSITE Anchors is a line extension to the currently marketed GRYPHON Anchor family. The proposed product is a knotless anchor intended for fixation of soft tissue to bone in various soft tissue repair procedures. In its finished good configuration, the proposed device is a two-piece design; comprised of a permanent implant (anchor) component and a disposable (inserter) component. The 2.7mm anchor implant is preloaded on the inserter and a Nitinol distal tip retains the suture and the anchor while the device is malleted into the bone. The design offers surgeons maneuverability within the joint space. The disposable inserter will be offered in two design configurations, straight or curved to accommodate varying anatomies. The proposed GRYPHON Flex Knotless PEEK and BIOCOMPOSITE Anchors will be available in a 2.7 mm size, molded from either Polyetheretherketone (PEEK) material or Absorbable Biocryl Biocomposite ((Polylactic Acid (PLA) and Tricalcium Phosphate (TCP)) material. Both the GRYPHON Flex Knotless PEEK and BIOCOMPOSITE Anchors are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.

The TriALTIS™ Spine System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The TriALTIS™ Spine System is intended for pedicle fixation of the thoracic, lumbar, and sacral spine (T1-S2) and nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies): spondvlolisthesis: trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor, pseudarthrosis; and failed previous fusion in skeletally mature patients. When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System metallic implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric screw fixation is limited to a posterior approach. When used for posterior pedicle screw fixation of the thoracic, lumbar, and sacral spine (T1-S2) in pediatric patients, the TriALTIS™ Spine System is indicated as an adjunct to fusion to treat progressive spinal deformities (i.e., scoliosis, or lordosis) including adolescent idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the TriALTIS™ Spine System is intended to treat pediatric patients diagnosed with: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. The TriALTIS™ Spine System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. When the TriALTIS™ Spine System fenestrated screws are used in conjunction with CONFIDENCE™ High Viscosity Spinal Cement, the TriALTIS™ Spine System is intended to stabilize the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. The TriALTIS™ fenestrated screws augmented with the CONFIDENCE™ High Viscosity Spinal Cement is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The TriALTIS Spine System is a posterior system intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic lumbar and sacral spine (T1-S2). The system is composed of multiple components to allow the surgeon to build an implant system to fit the patient s anatomical and physiological requirements. The system consists of bone anchors (such as screws) for connection by longitudinal components (such as rods) via an interconnection mechanism (e.g., set screws) to link the longitudinal components for addity. The TriALTS System implant components are comprised of Titanium alloy conforming to ASTM F136, and Cobalt-Chromium-Molybdenum alloy conforming to ASTM F1537.

The MITEK TIGHT-N™ Tendon Docking Anchor is indicated for use for reattachment of soft tissue to bone for the following procedures: • Shoulder: Biceps tenodesis • Knee: Medial patellofemoral ligament repair/reconstruction (MPFL), posterior oblique ligament repair (POL), medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, anterolateral ligament (ALL) reconstruction, Iliotibial (IT) Band Tenodesis

The MITEK TIGHT-NTM Tendon Docking Anchor is designed to reattach soft tissue to bone when used in conjunction with suture (provided separately). The anchor is preloaded on a disposable inserter shaft with handle, held in place by a non-absorbable "stay suture". The proposed anchor will be offered in three sizes: 5.5 mm, 7.0 mm, and 8.5 mm and is molded from PEEK (Polyetheretherketone) material. The proposed anchor is provided sterile via Ethylene Oxide (EO) sterilization and is for single use only.

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 discectorny 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 precalibrated with 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 Instrument, when used with UNAS, can be 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.

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. The Discectomy Navigation Ready Instruments are part of the DePuy Synthes Navigation Ready Instruments Portfolio. The instruments include Cobb Elevators, Curettes and a Bone Graft Delivery Device. 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 Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes: - Brainlab compatible UNAS Navigation Arrays, ● - 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 Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument, a UNAS Navigation Array can be attached and the instrument can be used only 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 PERMALOOP Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue. The PERMATAPE Suture is indicated for orthopedic procedural use in soft-tissue approximation including use with allograft tissue.

The PERMATAPE™ Suture is a 1.3mm wide, synthetic, sterile, flat braided suture composed of dyed and un-dyed (chromium cobalt aluminum oxide <2.0%, 21 CFR 73.1015), non-absorbable polyethylene. The PERMATAPE Sutures are provided with and without stainless steel needles. The PERMALOOP™ Suture is a suture loop constructed from the proposed PERMATAPE 1.3mm Suture. The PERMALOOP Sutures are offered with a curved, stainless steel needle attachment configuration or a straight, stainless steel needle attachment configuration. Both the PERMATAPE Suture and PERMALOOP suture are sterile via Ethylene Oxide (EO) sterilization and are for single use only. The devices are provided packaged in a pack of twelve (12).