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The ProAM ALIF System is an intervertebral body fusion device intended for spinal fusion procedures at one or two contiguous levels of the lumbosacral (L2-S1) spine in skeletally mature patients with degenerative disc disease (DDD), degenerative spondylolisthesis, and/or spinal stenosis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and imaging studies (radiographs, CT, MRI). DDD patients may also have up to grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). The ProAM ALIF System can be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis and sagittal deformity. However, when used in these patients at multiple levels, and for patients with degenerative spondylolisthesis and spinal stenosis at one or two adjacent levels, the system must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation. Interbody devices used with three fully threaded bone screws and which have a lordotic angle of 20° or less can be used as standalone interbody fusion devices at one or two contiguous levels without the need for supplemental fixation. Interbody devices with a lordotic angle greater than 20° must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation. Interbody devices used with fewer than three fixation components (OLIF devices and 2-Hole ALIF devices) or used with anchors or impacted screws must be used with supplemental spinal fixation systems cleared by the FDA for fusion of the lumbar spine in addition to the integrated fixation. The ProAM ALIF System is intended for use on patients who have had at least six months of nonoperative treatment. It is intended to be used with autograft and/or allogenic bone graft comprised of cortical, cancellous, and/or corticocancellous bone, and/or demineralized allograft bone with bone marrow aspirate.

The ProAM ALIF System is an intervertebral body fusion system that consists of an intervertebral body fusion device manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F3001) and fixation devices manufactured from titanium alloy (Ti-6Al-4V conforming to ASTM F136). The intervertebral body fusion device has a cross-sectional shape that is somewhat oval, and the device is otherwise box-shaped in stature with cavities for containment of bone graft material. The device is available in sizes that vary in footprint size, height, and lordotic angle. It is available in configurations meant for direct anterior insertion (ALIF) or oblique-anterior (OLIF) insertion. Devices for implantation via a direct anterior approach are available with 2 or 3 holes through which screws are placed to affix to bone. Devices for implantation via an oblique-anterior approach have 2 holes through which screws are placed to affix to bone. All devices have an open, porous architecture throughout and a pyramidal textured porous surface at the endplate contacting surfaces that helps prevent device migration. The fixation devices consist of Bone Screws, Impacted Screws, and Curved Anchors. Bone Screws are available in various diameters and lengths and engage the vertebral bodies by passing through the intervertebral body fusion device and into bone. They are turned to fixate to the bone. Impacted Screws are available in various lengths. They are first impacted through the intervertebral body fusion device into bone and then turned to further fixate to the bone. Curved Anchors are available in various lengths and are impacted into the bone through the intervertebral body fusion device. The purpose of this premarket notification is to add the Impacted Screws and Curved Anchors as fixation devices for the ProAM ALIF System

The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools. The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System. The TMINI® Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications: - Enovis™ EMPOWR Knee System® - Ortho Development BKS® and BKS TriMax® Knee System - Total Joint Orthopedics Klassic® Knee System - United U2™ Knee Total Knee System - Medacta® GMK® Sphere / SpheriKA Knee Systems - Zimmer Biomet Anterior & Posterior Referencing Persona® Knee - b-ONE MOBIO® Total Knee System - Maxx Orthopedics Freedom® Total & Titan Knee - LINK® LinkSymphoKnee System

The TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation (TPLAN® Planning Station) including THINK Case Manager (TCM) the web-based method for surgeons to review, approve and download approved surgical plans, an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components. The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool. The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively using TNav.

For implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.

Restrata Soft Tissue Reinforcement (STR) is an electrospun fiber matrix intended for implantation to reinforce soft tissue where weakness exists, in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery. Restrata Soft Tissue Reinforcement is composed of resorbable synthetic fibers engineered from biocompatible materials. The fibers comprising Restrata STR are produced from polyglactin 910 (PGLA 90:10) and polydiaxonone (PDO). Contents of the package are provided sterile. The device is intended for one-time use.

The Vessel Sealer Curved is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue, and for bipolar coagulation and mechanical transection of blood vessels (veins and arteries) up to 7 mm in diameter, lymphatic vessels, and tissue bundles that fit in the jaws of the instrument. The Vessel Sealer Curved has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Vessel Sealer Curved is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing. The Vessel Sealer Curved device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the Intuitive Electrosurgical generator, E-200. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Models: IS4000 and IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically-assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

This 510(k) is for a labeling modification only, to include "tracheobronchoplasty for symptomatic, severe tracheobronchomalacia" as an additional representative, specific procedure under the previously cleared "General Thoracoscopic Surgical Procedures and Thoracoscopically-Assisted Cardiotomy Procedures" Indications for Use for the da Vinci Xi Surgical System, Model IS4000 (K131861) and the da Vinci X Surgical System, Model IS4200 (K171294). There are no changes to the technological characteristics of the cleared da Vinci Xi or X Surgical Systems (Models IS4000 and IS4200) proposed in this submission. The da Vinci Xi and X Surgical Systems, Models IS4000 and IS4200, are software-controlled, electro-mechanical systems designed for surgeons to perform minimally invasive surgery. The Model IS4000 and Model IS4200 Surgical Systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an Endoscope, EndoWrist Instruments, and Accessories.

The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, using near-infrared imaging.

The *da Vinci SP* Firefly Imaging System is a fully integrated, adjunct imaging system for the *da Vinci SP* Surgical System. The *da Vinci SP* Surgical System is a robotic-assisted surgical device (RASD) that is designed to enable complex surgery using a minimally invasive approach. The system consists of three major subsystems: the Surgeon Console, the Vision Cart, and the Patient Cart. The *da Vinci SP* Firefly Imaging System consists of the following components of the *da Vinci SP* Surgical System (refer to *Figure 1*): o the *Endoscope Controller (light source)* on the Vision Cart o the *SP Endoscope, 0° (subject device)*, which is installed on the Patient Cart The *Endoscope Controller* provides a light source, either visible light or a near-infrared (NIR) excitation laser. The *Endoscope* transmits visible light or NIR light from the Endoscope Controller via optical fibers to illuminate the surgical site. The stereoscopic camera at the Endoscope tip images the surgical site in either visible light mode or fluorescence imaging mode.

da Vinci SP Surgical System, Model SP1098: The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical da Vinci SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. da Vinci SP Instruments: Intuitive Surgical da Vinci SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The da Vinci SP Surgical System is designed to enable complex surgery using a minimally invasive approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories. The surgeon seated at the Surgeon Console controls all movement of the instruments and camera by using two hand controls and a set of foot pedals. The surgeon views the camera image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features. The Vision Cart includes supporting electronic equipment, such as the camera light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the camera image and adjust system settings. The Patient Cart is the operative component of the da Vinci SP Surgical System. Its primary function is to support the positioning of the surgical port and to manipulate the surgical instruments and camera. The Patient Cart is positioned at the operating room and contains an instrument arm that is positioned with respect to the target patient anatomy. The instrument arm contains four instrument drives that hold up to three surgical instruments and the camera. The patient-side assistant installs and removes the camera and instruments intra-operatively. This 510(k) is for a labeling modification only, to add "transanal local excision (TALE)" as a new representative, specific procedure in the Professional Instructions for Use.