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Mfinity femoral stems are indicated in patients requiring hip arthroplasty. Total or partial hip arthroplasty is indicated in the following cases: - Severely painful and/or disabled joint as a result of osteoarthritis, post-traumatic arthritis, inflammatory arthritis or hip dysplasia. - Avascular necrosis of the femoral head. - Acute fracture of the femoral head. - Acute fracture of the proximal femur, suitable to be treated by means of hip arthroplasty. - Non-union of proximal femur fracture, suitable to be treated by means of hip arthroplasty. - Primary pathology involving the femoral head but with a non-deformed acetabulum. - Failure of previous hip surgery: - Conservative hip surgery. - Internal fixation. - Arthrodesis. - Partial or total hip arthroplasty. - Hip resurfacing replacement.

The Mfinity Femoral System includes implantable devices provided individually packed, sterile and single-use intended for cementless use in total or partial hip arthroplasty to replace the native femoral neck for primary or revision surgery. The product range is composed of three different versions (Mfinity collarless, Mfinity collared and Mfinity L) available in standard and lateral offset. The Mfinity femoral stem can be combined with the CoCr ball head (K072857, K080885 and K103721), Endo Head (K111145), the MectaCer BIOLOX® forte (K073337), MectaCer BIOLOX® Delta Femoral Heads (K112115) or MectaCer BIOLOX® Option Heads (K131518). The subject devices are made of titanium alloy according to ISO 5832-11 and coated with Titanium plasma spray according to ASTM F1580 and Hydroxyapatite according with ASTM F1185.

Mpact 3D Metal Augments are intended for cementless use to the bone interface and are affixed to a compatible Medacta Acetabular shell using bone cement in hip replacement surgeries. Mpact 3D Metal Augments are indicated in cases of: - Acetabular dysplasia; - Acetabular fractures; - Revision of previous implants in the presence of insufficient bone quality or seriously altered bone structures.

The Mpact 3D Metal Augment II is an acetabular implant intended to be used in Total Hip Arthroplasty cemented to its Medacta compatible Acetabular Shell. It is provided sterile and individually packaged to the end user. The devices subject of this submission are: - Mpact 3D Metal Augments II from size Ø46 to Ø80, made of Ti6Al4V according to ASTM F2924; - Double Augment Technique Screw, made of Ti6Al4V according to ISO 5832-3. The Mpact 3D Metal Augments II represent the second generation of the Mpact 3D Metal Augments cleared within K171966.

The MySpine WebPlanner software is designed to be used by a competent person who will generate a preoperative plan that may give relevant information to an authorized orthopedic or neurosurgeon before spinal posterior fixation surgery. The MySpine WebPlanner is a surgical preoperative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of Medacta's spinal fixation and fusion devices in skeletally mature and immature individuals. The MySpine WebPlanner software is designed to support the surgeon in producing a preoperative plan and making preliminary decisions on implant size and positioning. To properly use the MySpine WebPlanner, clinical judgment, and experience are required.

The MySpine WebPlanner is an interactive web application using the patient's radiological images and the related bone segmentations to allow the end-users to perform preoperative surgical planning. The data and the information displayed in WebPlanner web interface are computed and loaded by Medacta International's internal software named MyPlanner. The image format supported is DICOM. The end-user can access the MySpine WebPlanner at https://myspine.medacta.com/. The purpose of the current submission is to obtain clearance to expand the indications for use of MySpine WebPlanner include surgical planning of fusion devices (i.e., cages).

Versacem is designed for use in total hip arthroplasty, for selected primary or revision surgery. Total hip arthroplasty is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthrosis, traumatic arthritis, rheumatoid polvarthritis 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, partial hip arthroplasty, hip resurfacing replacement or total hip arthroplasty. Versacem is also recommended when dislocation prevention is the main driver for the prosthesis choice and the acetabular bone quality is damaged, as in the following cases: - · Elderly patients or poor bone quality. - · Revision for recurrent dislocation in elderly patients with poor bone quality. - · Patients treated with radiotherapy or chemotherapy. Versacem is intended for cemented use only.

The purpose of this submission is to gain clearance for the Versacem Acetabular Shell and to add two new sizes of the compatible Double Mobility HC Liners previously cleared within K092265, K131458 and K143453. The Versacem Acetabular Shell implants and the Double Mobility HC liners are sterile, individually packaged, implantable medical devices intended to be used in Total Hip Arthroplasty. The devices subject of this submission are: - . Versacem Acetabular Shell from size Ø40 to size Ø56; - . Double Mobility HC liner Ø22.2/DMAZ; - Double Mobility HC liner Ø28/DMC. ●

The MyShoulder Planner software is a medical device intended for use by surgeons as a preoperative planning tool for total shoulder replacement surgery in skeletally mature individuals. The MyShoulder Planner software is specifically designed to support the planning of the humeral and glenoid components in a total shoulder replacement using Medacta Shoulder System prosthesis. The MyShoulder Planner software should not be used for diagnostic purposes. The MyShoulder Planner software processes CT scan images in DICOM format to allow surgeons to visualize, measure, and reconstruct anatomic data. These features enable surgeons to make decisions on implant size and positioning, including the ability to annotate anatomical structures. The MyShoulder Planner software leads to the generation of patient-specific planning reports, which summarize the preliminary decisions regarding implant size and positioning. The MyShoulder Planner software allows the surgeons to request the MyShoulder patient matched guides according to the pre-surgical plan.

The MyShoulder Planner is a software designed to create patient-specific preoperative plans based on CT scans. It is used to visualize the effect of different devices and positioning options on the patient's shoulder joint biomechanics. It allows the surgeon to preoperatively plan the humeral and glenoid components in total shoulder replacement after the segmentation of a 3D model of the patient's anatomy that can be performed automatically by the software, which uses machine learning algorithms, or manually by a designated Medacta engineer.

· M.U.S.T. Fenestrated Pedicle Screw The M.U.S.T. Fenestrated Pedicle Screw System when used without cement is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5). These devices are indicated as an adjunct to fusion for all of 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; pseudoarthrosis; and failed previous fusion in skeletally mature patients. When used in conjunction with Meta+ Spine cement, the M.U.S.T. Fenestrated Pedicle Screw System is 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 thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. M.U.S.T. Fenestrated Pedicle Screw System augmented with Meta+ Spine cement is intended for use at spinal levels where the structural integrity of the spine is not severely compromised. · Meta+ Spine Cement Meta+ Spine cement, when used in conjunction with the M.U.S.T. Fenestrated Pedicle Screw System, is 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 thoracic and lumbar spine, in whom life expectancy is of insufficient duration to allow for achievement of fusion. The M.U.S.T. Fenestrated Pedicle Screw System, augmented with Meta+ Spine Cement, is for use at spinal levels where the structural integrity of the spine is not severely compromised.

The purpose of this submission is to gain the clearance for the Meta+ Spine Cement to be used in conjunction with the M.U.S.T. Fenestrated Pedicle Screw System, a Medacta M.U.S.T. Pedicle Screws System line extension including the following screws: - A. Poly-Axial Screws with standard screw head design, Ø 5, 6 mm (Dual Diameter) and 7mm (Single Diameter) - B. Poly-Axial Screws with large screw head design, Ø 7, 8, 9, 10 mm (Dual Diameter) - C. Mono-Axial Screws, Ø 5, 6, 7 mm (Dual Diameter) - D. Long Tab (LT) Poly-axial screws Ø 4.5. 5. 6. 7. 8 mm (Single Diameter). The Meta+ Spine Cement as well as the M.U.S.T. Fenestrated Pedicle Screws are provided individually packed, sterile and single-use.

The Mbrace Cable is designed as a cerclage system for long bones and to reattach the greater trochanter in case of fractures or osteotomies. The device is intended for long-term implantation inside the human body for single use only. The Mbrace Cable is not intended for use as a suture cable in soft tissue approximation and/or ligation.

The Mbrace cable is an implantable flexible braided cable made of UHMWPE and designed as a cerclage bone system. The Mbrace cable is provided individually packed, sterile and single-use.