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The NextAR Spine platform is intended as an aid for precisely locating anatomical structures in either open or percutaneous spine procedures. It is indical for any medical condition in which the use of stereotaxtic surgery may be appropriate, when reference to a rigid anatomical structure, such as vertebrae or pelvis, can be identified relative to images of the anatomy. This can include the following spinal implant procedures, such as: - · Pedicle Screw Placement (Thoracic and Lumbosacral spine) - Iliosacral Screw Placement The NextAR Spine platform is intended to be used in combination with NextAR™M Stereotaxic instruments and / or Medacta preoperative planning. In the case of pre-operative planning software is used preoperatively to plan the surgical placement of pedicle screws based upon radiological images of the patient. As an optional display, the NextAR Smart Glasses can be used auxiliary to the NextAR Spine Platform to view stereotaxic information as presented by the NextAR Spine Platform. The NextAR Smart Glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

The NextARTM Spine Platform is a CT based computer-assisted surgical navigation platform used in either open/mini open or percutaneous spine surgery procedure and includes the following components: - Navigation software which displays information to the surgeon; ● - Augmented Reality glasses; ● - Optical tracking system; ● - PC based hardware platform; ● - Fiducial Block: ● - Adaptor for sensor: - Spine attachment instruments ● - Reusable surgical instruments for spine surgery procedures. ● The system operates on the common principle of stereotaxic technology in which markers are mounted on the bones and an infrared camera is used to monitor the spatial location of the instruments. Tracking sensors attached to the bones enable the surgeon to view the position and orientation of the instrumentation relative to the intra-operative data in real-time while performing the surgical procedure. The tracking sensors, the fiducial block, and a group of pins and drills are provided sterile. The NextAR™ Spine Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time on a screen monitor. The NextAR Spine system is a surgical navigation platform which uses the information of either an intra-operative scan or pre-operative CT in combination with an intra-operative 3D-CArm scan in order to register the spine to navigation elements. The registration can be performed with one of the following approaches: - Direct 3D: based on the use of an intra-operative 3D-CArm scan ● - . 3D-3D: based on the use of a pre-operative CT scan and an intra-operative 3D-CArm scan The system's navigation technology is based on an active infrared camera coupled with an active tracker (Target). These elements allow, by means of the different registration approaches and use of compatible instruments, to accurately prepare trajectories in the vertebrae and/or to implant screws while visualizing information in real time on a screen monitor.

The Mpres stem is a cementless neck preserving stem designed for use in total or partial hip arthroplasty for primary or revision surgery. Total Hip Arthroplasty with the Mpres stem is indicated in the following cases: · Severely painful and/or disabled joint as a result of arthritis, rheumatoid polyarthritis or congenital hip dysplasia. · Avascular necrosis of the femoral head. - · Acute traumatic fracture of the femoral head. - Failure of previous hip surgery: o Conservative hip surgery, o Internal fixation, o Arthrodesis, o Hip resurfacing replacement. Partial hip arthroplasty with the Mpres stem is indicated in the following cases: - · Acute traumatic fracture of the femoral head. - · Avascular necrosis of the femoral head. · Primary pathology involving the femoral head but with a non-deformed acetabulum.

The Mpres Neck Preserving Stem is a cementless short femoral stem intended to be used in total or partial hip arthroplasty for primary or revision surgery with minimally invasive hip replacement techniques. The Mpres Neck Preserving Stem is made of titanium alloy (Ti6Al7Nb) according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite in compliance with ASTM F1185. It is available in 12 sizes (sizes 3-14) for each neck variation configuration: a standard 130° CCD angle or an high offset 123° CCD angle.

Medacta Shoulder System - Reverse Reverse Shoulder Prosthesis The Reverse Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with a grossly rotator cuff deficient shoulder joint, severe arthropathy failed joint replacement and a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application of screws for primary stability. Short Humeral Diaphysis The Reverse Shoulder Prosthesis- Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with grossly deficient rotator cuff shoulder joint with severe arthropathy. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The glenoid baseplate is intended for cementless application with the addition of screws for fixation. Medacta Shoulder System - Anatomic Anatomic Shoulder Prosthesis The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement. The patient's joint must be anatomically suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application. Short Humeral Diaphysis The Medacta Anatomic Shoulder Prosthesis – Short Humeral Diaphysis is indicated for primary total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary for the device to offer full function in vivo. The glenoid component is intended for cemented application.

The Medacta Shoulder Systems are modular systems intended to be used for shoulder arthroplasty (anatomical or reverse). System components were previously cleared by the FDA under K170910 (anatomic shoulder prosthesis) and K170452 (reverse shoulder prosthesis). The Long Humeral Diaphysis implants, subject of this 510(k), are implantable devices used to replace the humeral side of the gleno-humeral joint. The product is intended to be used with the Medacta Shoulder System components as an alternative to the Standard Humeral Diaphysis components provided with those systems. The Medacta Shoulder System Long Humeral Diaphysis couples with the Humeral Reverse Metaphysis (K170452) in the reverse configuration and the cemented and cementless Humeral Anatomic Metaphysis (K170910) in the anatomic configuration. The long humeral diaphysis, provided in 160 mm and 200 mm length options, may be used when additional distal stability in the humeral canal is needed. The subject devices are manufactured from titanium alloy (Ti6A17Nb) and are provided sterile in 11 sizes per length option.

The MectaLIF implants in combination with supplemental fixation are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2 – S1 whose condition requires the use of interbody fusion. Degenerative disc disease is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s). Patients must be skeletally mature. Patients should have received 6 months of non-operative treatment prior to treatment with the devices.

MectaLIF Transforaminal lumbar intervertebral body fusion device is characterized by different sizes of PEEK-OPTIMA LT1 (Polyetheretherketone) implants that can be applied with a TLIF procedure (Transforaminal Lumbar Intervertebral Fusion). Mectal IF Transforaminal is used to replace a degenerative disc in order to restore the height of the spinal column structure. They are made of PEEK-OPTIMA LT1 and contain Tantalum Markers as well as a titanium gear which enables the surgeon to alter the angle of the MectaLIF Transforaminal in situ in 15° increments and to reposition during surgery without switching instrumentation. MectaLIF Transforaminal is intended to be used in combination with posterior fixation (e.g. Pedicle Screw System) as well as an autogenous bone graft. The dimensions of MectaLIF Transforaminal are within the following range: Length 30-34mm; Height 8-15mm; Width 12-14mm; Lordosis 5°. The materials of the components of MectaLIF Transforaminal are as follows: Implant: PEEK-OPTIMA LT1: Implant Grade Polyetheretherketone (ASTM F 2026), Gear: Titanium: Ti6Al4V ELI (ISO 5832-3/ASTM F 136), and Marker: Tantalum (ISO 13782 / ASTM F 560).

The GMK® Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - · Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis. - · Avascular necrosis of femoral condyle. - · Post traumatic loss of joint configuration. - · Primary implantation failure. The tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components.

This modification to the original Medacta GMK® (Global Medacta Knee) Total Knee System is a line extension to include the GMK® Revision SC (Semiconstrained) liners. The GMK® Revision SC liners work with components from the GMK® Total Knee System and from the GMK® Revision, a previously cleared Special 510(k) to the GMK® Total Knee System. The GMK® Revision SC Liners, the subject of this 510(k), are a set of tibial inserts which work with the GMK® Revision femoral PS components and the GMK® tibial baseplates. These liners provide the surgeon with an additional option. The GMK® Revision SC Liners are offered in six sizes with seven thicknesses from 10 mm to 26 mm. The GMK® Revision SC Liners are attached to the GMK® tibial baseplates of the same size from the GMK® Total Knee System using a support peg made of CoCrMo. The device is used to replace the articular surface of the tibial plateau in the knee joint by limiting the movement of the prosthetic femoral component in translation and rotation. The GMK® Revision SC Liners attached to the GMK® tibial baseplates can also be combined with an extension stem, an offset connector and tibial wedges.

The Medacta Total Hip Prosthesis System – Quadra C Femoral Stems are intended for cemented use in total or partial hip arthroplasty and in primary or revision surgery. Hip replacement is indicated in the following cases: Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia; Avascular necrosis of the femoral head; Acute traumatic fracture of the femoral head or neck; Failure of previous hip surgery, joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. Size 0 implants should not be implanted in patients with a mass of 65 kg or greater.

This modification to the original Medacta Total Hip Prosthesis System -Quadra C femoral stems is a line extension to include the AMIStem C femoral stems and Quadra C Short Neck (SN) femoral stems. AMIStem C femoral stems are based on the design of the Quadra C femoral stems in the original submission. The AMIStem C femoral stems differ from the Quadra C femoral stems by a decreased length of 15% and a reduced shoulder. The Quadra C short neck femoral stems are the same design femoral stems as the Quadra C femoral stems in the original submission but the length of the neck that is 5 mm shorter. Like the Quadra C femoral stems, the AMIStem C femoral stems and the Quadra C SN femoral stems are highly polished, collarless femoral components manufactured from forged stainless steel according to ISO 5832-9. The AMIStem C femoral stems and the Quadra C SN femoral stems are straight quadratic stems with a triple taper shape. The proximal portion of the stem has a standard 12/14 taper for mechanical attachment to cleared Medacta International metallic or ceramic femoral heads. Like the Quadra C femoral stems, two different caput-collum-diaphyseal angles (CCD) are available for the AMIStem C femoral stems and the Quadra C Short neck femoral stems: 135° for the standard offset and 127° for the lateralized offset. The Quadra C short neck femoral stems come in eight sizes with a standard offset and seven sizes with a lateral offset. The AMIStem C femoral stems come in eight sizes with a standard offset and seven sizes with a lateral offset. There are no short neck versions for the AMIStem C femoral stems. The AMIStem C femoral stems and the Quadra C short neck femoral stems provide additional femoral stem options to the surgeon for use with the Medacta Total Hip Prosthesis System.

The GMK® Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis - avascular necrosis of femoral condyle . - post traumatic loss of joint configuration . - primary implantation failure. . The tibial augments are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.

The modification to the original Medacta GMK® (Global Medacta Knee) Total Knee System is a line extension to include the GMK® Revision femoral components (STD and PS), extension stems with offset adaptors, distal and posterior femoral wedges and tibial wedges. GMK® Revision femoral components are based on the design of the GMK® Primary femoral components in the original 510(k) submission K090988. The GMK® Revision differs from GMK® Primary by an internal box that allows attachment of the extension stem and the femoral pegs are replaced by two threaded holes to attach femoral wedges. GMK® Revision femoral components are available in two versions, standard and posterior stabilized femurs, left and right from size 1 to 6. The femoral posterior wedges include sizes 1- 6 with a thickness of 5mm and 10mm while the femoral distal wedges are available in the same size range (1- 6), in thicknesses of 4mm, 8mm and 12mm. Distal and posterior wedge screws are offered in 4mm, 8mm, and 12mm. GMK® Revision femoral components work with the same Tibial baseplates, UC tibial inserts, posterior stabilized tibial inserts and patellas cleared under the original GMK® Total Knee System, K090988. The offset adaptors are available in 3mm and the associated extension stems are offered in diameters of 11mm, 16mm, 19mm and 20mm with each being 65mm, 105mm or 150mm in length. The tibial wedges are available in size 1- 6 at a thickness of 5mm or 10mm.

MyKnee Cutting Blocks are intended to be used as anatomical cutting blocks specific for a single patient anatomy to assist in the positioning of total knee replacement components intraoperatively and in guiding the marking of hone before cutting. MyKnee Cutting Blocks are intended for use with GMK Total Knee System and its cleared indications for use. MyKnee Cutting Blocks are intended for single use only.

MyKnee Cutting Blocks are designed and manufactured from patient imaging data so that the cutting blocks match the patient's anatomy. The MvKnee Cutting blocks for the patient are used with Medacta's existing GMK Total Knee System.

The iMNS Medacta Navigation System is intended to be used to support the surgeon during specific orthopedic surgical procedures by providing information on bone resections, instrument and implant positioning during joint replacement. The iMNS Medacta Navigation System provides computer assistance to the surgeon based on anatomical landmarks and other specific data obtained intra-operatively that are used to place surgical instruments. Examples of some surgical procedures include but are not limited to: Total Knee Replacement Minimally Invasive Total Knee Replacement

The iMNS Medacta Navigation System is a device for computer aided navigation of surgical instruments used in total knee replacement surgery. The system works on the common principle of stereotaxic technology in which passive markers are securely mounted on the patient's bones and an infrared camera is used to monitor the spatial location of those markers. This information is used to locate the anatomical landmarks such as centers of rotation of the femur head, knee and ankle intraoperatively. These measurements are displayed on a computer screen in real time. The instruments are then outfitted with the passive markers to improve the positioning of the cutting guides. The information from the system with the "navigated" instruments assists the surgeon in conducting the bone resections and positioning of the orthopedic surgical implants. The surgeon maintains control of the surgery and makes any decisions required with regard to bone resections and implant positioning but the iMNS Medacta Navigation System provides real time support and information throughout the surgery. The iMNS Medacta Navigation System consists of the following kev components: - · An acquisition system composed of two infrared cameras equipped . with infrared light emitting diodes (LED) to track the position of the passive markers. - . A computer running the proprietary Medacta software and a monitor, - . Interface devices of a keyboard, foot pedal and optional mouse to control the system, and - Manual reusable surgical instruments. . The software application called GMK v4.2.2 is designed to work with Medacta's GMK Total Knee System, cleared under K090988. The manual reusable surgical instruments include instruments specifically designed for navigated surgery and other standard surgical instruments needed to conduct total knee replacement.

The Versafitcup™ Double Mobility Family is intended for cementless use in total hip arthroplasty and in primary or revision surgery. The patient should be skeletally mature. The patient's condition should be due to one or more of: - Severely painful and/or disabled joint as a result of osteoarthritis, post traumatic arthritis, rheumatoid arthritis, or psoriactic arthritis, - Congenital hip dysplasia - Ankylosing spondylitis - Avascular necrosis of the femoral head - Acute traumatic fracture of the femoral head or neck - Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. - Dislocation risks

The Versafitcup™ Double Mobility Highcross® HXUHMWPE liners are a modification of the polyethylene liners to be made of a highly crosslinked ultra high molecular weight polyethylene. The liners are identical in sizes, dimensions and functionality as the standard UHMWPE liners which were cleared as part of the original 510(k) submission. The Highcross® UHMWPE liners are manufactured from UHMWPE that has been crosslinked by controlled exposure to radiation followed by a stabilizing heat treatment prior to machining of the liners. The crosslinked UHMWPE has physical and mechanical properties that are similar to those of standard UHMWPE but has increased resistance to wear. The Highcross® highly crosslinked UHMWPE meets all of the specifications of ASTM F648. There is no change to the metal acetabular cup of the Versafitcup™ Double Mobility system. The polyethylene double mobility liner is designed to articulate freely within the metal acetabular cup. The Versafitcup™ Double Mobility acetabular cup has a highly polished inner surface to facilitate this articulation. The Versafitcup™ Double Mobility Family including the new highly crosslinked UHMWPE liners are designed to be used with the Medacta Total Hip Prosthesis' Quadra Stems and ball heads (K072857, K073337, K080885, K082792).