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FairFix Adjustable Buttons are intended to be used during a knee ligament (i.e. anterior cruciate ligament and posterior cruciate ligament) reconstruction surgery when a Ø4.5 mm tunnel is realized. FarFix Extenders are intended to be used in association with any FairFix Adjustable Button configuration during a knee ligament (i.e. anterior cruciate ligament) reconstruction surgery with a Ø 6 - 11 mm tunnel.

The FairFix Adjustable Button Extender Round implants are a Medacta SportsMed devices line extension providing alternative implantable fixation devices to be used during knee ligament reconstruction surgery for the fixation of the graft in association with the FairFix Adjustable Buttons (cleared within K203259 and K221389) in case of large tunnel conditions (e.g. cortical blowout, revision cases, full tunnel). The subject FairFix Adjustable Button System implants are available in three different sizes and they consist of a circular metal plate provided with a recess specifically designed to house the FairFix Adjustable Button.

Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of auto- and allografts.

The MectaScrew Extension includes implantable devices used for the tibial and the femoral fixation of the graft in reconstructive treatment of knee ligament ruptures. They have been developed to provide interference between a ligament graft and a bone tunnel in the ligament reconstruction surgery. The MectaScrew Extension implants includes MectaScrew C, a composite interference screw made of RESOMER® Composite LR 706S B-TCP, a mixture of 70 % RESOMER® LR 706 S and 30 % B-TCP. MectaScrew C is available in 19 different configurations ranging from 6 to 12 mm in diameter and 15 to 35 mm in length.

The Mpact® 3D Metal™ implants are designed for cementless use in total hip arthroplasty 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, rheumatic arthritis, rheumatoid arthritis or psoriatic 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present

The Mpact® 3D Metal Implants - DMLS Technology are sterile implantable devices intended to be used during Total Hip Arthroplasty. The devices subject of this submission are: - Mpact® 3D Metal Acetabular Shells Two-Hole Ø 46-66 mm manufactured through DMLS ● Technology; - . Mpact® 3D Metal Acetabular Shells Multi-Hole - Ø 46-72 mm - manufactured through DMLS Technology: - . Mpact® 3D Metal Acetabular Shells Multi-Hole Thin - Ø 48-60 mm - manufactured through DMLS Technology; and - . Compression Polyaxial Locking Screws - 11 sizes depending on screw length: from 20 to 70mm in 5mm steps. The Mpact® 3D Metal Acetabular Shells manufactured through DMLS Technology are a line extension to the Mpact® 3D Metal Acetabular Shells and 3D Metal Augments (K171966) and to the Mpact® Acetabular Systems Shells (K103721, K122641 and K132879) and are designed to be used with the Medacta Total Hip Prosthesis System. The subject Mpact® 3D Metal Acetabular Shells are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder. DMLS is a metal additive layer manufacturing process that uses a precise and high-wattage laser to "sinter" powdered metals and alloys to form accurate, complex and fully-functional metal parts directly from CAD data. Compression Polyaxial Locking Screws have been designed to provide fixation of implants to the cancellous bone and they can be considered a line extension to the predicate devices, Cancellous Bone Screws flat head, previously cleared within K103721 and K132879. The subject screws have a thread diameter of 6.5 mm and they can be coupled with implants that have dedicated fixation holes with a spherical seat shape of Ø8mm. The outer screw of the Compression Polyaxial Locking Screws is made of titanium alloy (Ti6-Al4-V) according to ISO 5832-3:2016, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6aluminum 4-vanadium alloy, while, the inner part, not in contact with bone, is made of Co-Cr-Mo alloy according to ISO 5832-12:2019, Implants for Surgery - Metallic materials - Part 3: Wrought cobaltchromium-molybdenum alloy.

The PAO cortical screws are intended to refixate the acetabular fragment to the ilium, after Periacetabular osteotomy.

The PAO cortical screws are implantable devices for acetabular refixation after a Periacetabular osteotomy. They are provided sterile and single-packaged, for single use only. The PAO cortical screws are designed in two different sizes (Ø3.5mm and Ø4.5mm), both available in different working lengths (from 20mm to 140mm and from 50mm to 140mm respectively) to be suitable to treat all the desired population. The PAO Cortical Screws are made of Stainless Steel AISI 316 LVM according to ISO 5832-1.

The MySpine WebPlanner is a surgical pre-operative planning software intended to provide assistance to surgeons in viewing, storing, and measuring radiological images, as well as planning the surgical placement of the spinal fixation devices. The MyBalance, a module of the MySpine WebPlanner, allows to perform generic as well as specific measurements of patient's sagittal alignment and to plan spinal surgical procedures ( osteotomies or Lordosis/ Kyphosis correction in spinal fusion surgeries). To properly use the MySpine WebPlanner, and the MyBalance module, clinical judgment and experience are required.

The subject device MySpine WebPlanner & MyBalance is an interactive web application using the patient's radiological images and the related bone segmentations to allow the end-users performing a pre-operative surgical planning. The data and the information displayed in the web interface named WebPlanner are computed and loaded by an internal software named MyPlanner. The MyBalance is an optional module of the MyPlanner, thus available on the WebPlanner interface, and it allows the surgeon to verify the actual patient sagittal alignment and to simulate a sagittal correction in order to determine balance condition after the planned correction. The image format supported is DICOM. The end-user with its credentials can access the MySpine WebPlanner at https://myspine.medacta.com/.

The Evolis/GMK knee prosthesis 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, traumatoid arthritis or polyarthritis. - Avascular necrosis of femoral condyle. - · Post traumatic loss of joint configuration. - · Primary implantation failure. Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the femoral components. In case a GMK Revision tibial tray is used, an extension stem must be implanted. GMK Sphere/Spherika can be implanted using a kinematic alignment approach. When a kinematic alignment approach is utilized, this knee replacement system is indicated in the following cases: · Severely painful and/or disabled joint as a result of arthritis, traumatoid arthritis, rheumatoid arthritis. - · Collagen disorders, and/or avascular necrosis of the femoral condyle. - · Moderate valgus, varus, or flexion deformities.

The purpose of this submission is to notify the FDA of the GMK SPHERE range Extension, that includes GMK Spherika Femurs and GMK Fixed Tibial Trays Plus. Subject devices are sterile implantable devices designed for tricompartment of the natural knee joint. The subject devices are marketed as individually packaged femoral and tibial components, designed for cemented use in total knee arthroplasty procedures. GMK Spherika femoral component is an implantable device intended to be used in case of total knee arthroplasty to replace the femoral articular surfaces of the knee joint. GMK Spherika femoral component can be used in Kinematic Alignment surgical technique. The Kinematic Alignment surgical technique was already cleared in K173890. GMK Tibial Trays Plus are a range extension of the GMK Tibial trays already cleared, in details they are fixed intermediate sizes of the tibia trays. The subject devices are a line extension to Medacta previously cleared implants: GMK Sphere (K121416), GMK Sphere Extension (K140826), GMK Knee Prosthesis- GMK Sphere Tibial Insert Flex (K162035), GMK Sphere - Kinematic Alignment ( K173890), GMK Sphere CR Tibial Inserts (K181635), GMK Sphere E-Cross (K202022), GMK Total Knee System-TiNbN Coating (K202684), Medacta International SA, GMK Total Knee System (K090988), GMK Line Extension (K120790), GMK Narrow K122232, MK Extension (K142069) and The subject devices are manufactured with the same materials of the previous cleared femurs and tibial trays. The submission includes the following implants: - . GMK Spherika Femoral Component Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4) - . GMK Spherika Femoral Component Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated - . GMK Spherika Femoral Component Anatomical, Cemented, Left and Right, Sizes from 1 to 7 and from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4) - GMK Spherika Femoral Component Anatomical, Left and Right, Sizes from 1 to 7 and . from 1+ to 6+ made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated - Tibial tray fixed cemented, Left and Right, Sizes from 1+ to 5+ plus 4 intermediate sizes ● made in Co-Cr-Mo (ISO 5832-4) - Tibial tray fixed cemented, Left and Right, Sizes from 1+ to 5+ plus 4 intermediate sizes made in Co-Cr-Mo (ISO 5832-4) and TiNbN Coated The subject devices, both Femoral Components and Tibial Trays, are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery -Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Allov. In regards to the Femurs and Tibial Trays TiNbN Coating, they are manufactured from cobaltchromium-molybdenum alloy (Co-Cr-Mo) according to ISO 5832-4:2014 Implants for Surgery -Metallic Materials-Part 4: Cobalt-Chromium-Molybdenum Casting Alloy with Titanium Niobium Nitride (TiNbN) coating. Like the predicate tibial trays devices, the tibial trays plus subject of this submission have a Fixed Tibial Tray Plug that is manufactured from Type 1 Ultra High Molecular Weight Polyethylene (UHMWPE) per ISO 5834-2: 2019 Implants for Surgery - Ultra-High-Molecular-Weight Polyethylene -Part 2: Moulded Forms. The subject device also includes the utilization of the GMK Sphere E-cross tibial insert FLEX, already cleared (K202022) in case of retention of an efficient posterior cruciate ligament in the Kinematic Alignment configuration. The Kinematic Alignment surgical technique was already cleared in K173890. In this case there are no new implants or instruments, GMK Sphere E-cross tibial insert FLEX, already cleared (K202022).

The Shoulder NextAR™ RSA Platform supports the surgeon during glenoid implantation in reverse shoulder replacement procedures providing information on bone preparation, instrument guidance, and implant positioning. The Shoulder NextAR™ RSA Platform works in conjunction with NextAR™ stereotaxic instruments and general surgical instruments to implant the Medacta Shoulder System Reverse Shoulder Arthroplasty). As an optional display, the smart glasses can be used auxiliary to the Shoulder NextAR™ Platform to view the same 2D stereotaxic information as presented by the Shoulder NextARTM Platform. The Shoulder NextAR™ stereotaxic instruments are to support the surgeon during specific orthopedic surgical steps by providing information on bone preparation, instrument guidance, and implant positioning. Once registered, the NextAR™ stereotaxic instruments provide reference to a patient's rigid anatomical structures on the surface of the glenoid that are identified relative to preoperative C.T. based planning. The smart glasses should not be relied upon solely and should always be used in conjunction with the primary computer display.

The Shoulder NextAR™ RSA Platform is a CT based computer-assisted surgical navigation platform used to perform a reverse shoulder arthroplasty on the glenoid and includes the following components: - PC based hardware platform; (K193559 and K202152) - optical tracking system; (K193559 and K202152) - Augmented Reality glasses; (K193559 and K202152) - Platform (K193559 and K202152) - navigation software which displays information to the surgeon in real-time; - Reusable surgical instruments to perform the surgical steps of a shoulder reverse arthroplasty ● on the glenoid. 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 markers. Tracking sensors attached to the scapula and surgical instruments enable the surgeon to view the position and orientation of scapula and instrumentation relative to preoperative data in real-time while performing the surgical procedure. The tracking sensors are provided sterile. Shoulder NextAR™ RSA Platform aids the surgeon in executing the surgical plan by visualizing all the information in real time on a screen monitor. The NextAR™ RSA system is intended to assist the surgeon in executing a preoperative surgical planning. The navigation platform tracks the surgical instruments in real-time and displays intraoperative and planned surgical parameters on a screen, thus allowing the surgeon to match the intraoperative parameters with the planned ones. Specifically, the navigation system utilizes established technologies of navigation and via an active infrared camera rigidly coupled with the scapula and an active infrared tracker that can be rigidly coupled to the surgical instruments. The registration of the patient's scapula on the preoperative scapula model is performed through the use of dedicated surgical instruments (pointers) and a dedicated registration algorithm.

The Mpact implants are designed for cementless use in total hip arthroplasty 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 psoriatic 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present. The Mpact 3D Metal Implants are designed for cementless use in total hip arthroplasty 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, rheumatic arthritis, rheumatoid arthritis or psoriatic 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, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present. The Augments 3D Metal are intended to be used in combination with the Mpact 3D Metal Multi-hole acetabular cup in hip replacement surgeries. The Augments 3D Metal are indicated in cases of: - Congenital dysplasia. - · Acetabular fractures. · Revision of previous implants in presence of insufficient bone quality or seriously altered bone structures. The Versafitcup CC Trio and the Versafitcup CC Trio No-Hole are designed for cementless use in total hip arthroplasty 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 or psoriatic 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, arthrodesis, hemiarthroplasty, surface replacement arthroplastv, or total hip replacement where sufficient bone stock is present.

The MPACT Extension implants subject of this submission are twelve (12) sizes of Cancellous Bone Screws. The subject devices are sterile implantable devices intended to be used during Total Hip Arthroplasty. Analogously to the predicate Cancellous Bone Screws flat head (K103721 and K132879), the subject Cancellous Bone Screws, are made of titanium alloy (Ti6-A14-V) according to ISO 5832-3:2016 Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6-aluminum 4vanadium allov. As the predicate devices, they have been designed with a thread diameter of 6.5 mm to provide fixation of implants to the cancellous bone. They can be coupled with implants that have dedicated fixation holes with a spherical seat shape of Ø8mm.

The M.U.S.T. Pedicle screws system is intended for posterior non-cervical pedicle fixation (T1-S2/ilium) and non-pedicle fixation, or anterolateral fixation (78-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, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

The M.U.S.T. Midline Cortical (MC) Screw System is intended to be used as part of the M.U.S.T. Pedicle Screw system (K12115, K132878, K141988, K153664, K162061, K171170, K171758, K193365) for the stabilization and the fusion of the lumbar and thoracic spine. The M.U.S.T. pedicle screw system includes cannulated or non-cannulated poly-axial pedicle screws (K121115, K132878, K153664), cannulated or non-cannulated mono-axial pedicle screws (K132878), set screws (K121115, K171758), straight and pre-bent rods (K12115, K141988, K162061), lateral connectors (K162061) and cross connectors (K132878, K193365). The M.U.S.T. pedicle screw system also includes the enhanced screws and rods designed for percutaneous surgery (K141988). The M.U.S.T. Midline Cortical (MC) Screw System introduce new polyaxial screws and reduction screws (solid and cannulated), developed with a focus on Midline Cortical Trajectory approach. The devices subject of this submission are: - M.U.S.T. MC polyaxial screws Solid - M.U.S.T. MC polyaxial screws Cannulated - M.U.S.T. MC polyaxial reduction screws Solid - M.U.S.T. MC polyaxial reduction screws Cannulated Intended purpose and the performance specification of the devices are equivalent to the ones of the current US cleared portfolio: polyaxial screws are already used in the MUST implant construct. The M.U.S.T. Midline Cortical (MC) Screws and the Inlay are manufactured from Ti-6Al-4V ELI (ISO 5832-3 Implants for surgery -Metallic materials - Part 3: Wrought titanium 6-vanadium alloy + ASTM F136 Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401); the Tulip and the Setscrew are made of Co-Cr-Mo alloy according to ISO 5832-12:2019, Implants for Surgery - Metallic materials -Part 3: Wrought cobalt-chromium-molybdenum alloy, the same material of the previous cleared M.U.S.T. Pedicle Screw (K153664, K121115, K171170).

The Medacta Ligament Staple is intended for use in medial collateral ligament (MCL) and lateral collateral ligament (LCL) reconstruction. Reconstructive treatment of ruptured or damaged MCL and LCL.

Medacta Ligament Staple is a single size (ø11 mm) extra cortical fixation device which is impacted on the Medial Collateral Ligament (MCL) or on the Lateral Ligament (LCL) for soft tissue to bone refixation by means of a dedicated impactor. The device consists of a circular plate with protruding tapered serrated legs, made of titanium alloy (Ti6A14V ELI according to ISO 5832-3 and ASTM F136), and a staple inlay, made of PEEK according to ASTM F2026, for pressing the graft down to the bone, featuring a lower spike patterned surface for increasing soft tissue fixation.