Medacta International Sa

Contact: Natalie Kennel
Web: http://www.medacta.com
Address: Strada Regina, Castel San Pietro 6874, Switzerland
Phone: +41-(91)-6966060 | Fax: +41-(91)-6966066 | Map/Directions >>

Profile: Medacta International Sa is an orthopaedic company providing prosthetic solutions for hip, knee and spine. We produce orthopaedics joint replacement product for hip, knee, navigation and biomaterials. Our hip joints are amis, primary, revision and gaston. Anterior minimally invasive surgery is characterized by a reduced skin incision and the preservation of muscles and tendons. Primary deals with stem, cups and heads. Revision deals with stem and cups. Quadra®stem, which belongs to the new generation of cementless hips, is suited to total hip arthroplasty. Our gaston is a pneumatic arm. It is conceived to the surgeon a practical valuable aid throughout the surgical procedure. Our knee joints are Evolis® and Cinetique®. Cinetique® knee and related ancillary provides two main targets, the respect of anatomy and optimal ligament balance. Evolis® allows a reproducible surgical act, offering at the same time several operative choices as well as checks during surgery. Our iMNSTM navigation system is designed to match both precision and ease of use. Our biomaterials include Highcross® and Mectacem®.

FDA Registration Number: 3005180920
US Agent: Christopher Lussier / Medacta Usa
Phone: +1-(901)-203-3470 E-Mail:

15 Products/Services (Click for related suppliers)

• Bone Fixation Screw (FDA Code: HWC / 888.3040)

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

• Calcium Compound Bone Void Filler (FDA Code: MQV / 888.3045)

A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.

• Calicum-Phosphate Non-Porous Metal/Polymer Uncemented Semi-Constrained Hip Prosthesis (FDA Code: MEH / 888.3353)

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A1203) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

• Cement Mixing Equipment (FDA Code: JDZ / 888.4210)

A cement mixer for clinical use is a device consisting of a container intended for use in mixing bone cement (888.3027).

• Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI / 888.3350)

A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (888.3027).

• Mechanical Operating Room Table (FDA Code: FWX / 878.4950)

A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.

• Metal/Polymer Femoral Hemi- Hip Prosthesis (FDA Code: KWY / 888.3390)

A hip joint femoral (hemi-hip) metal/polymer cemented or uncemented prosthesis is a two-part device intended to be implanted to replace the head and neck of the femur. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a snap-fit acetabular component made of an alloy, such as cobalt-chromium-molybdenum, and ultra-high molecular weight polyethylene. This generic type of device may be fixed to the bone with bone cement (888.3027) or implanted by impaction.

• Neurological Stereotaxic Instrument (FDA Code: HAW / 882.4560)

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

• Orthopedic Manual Surgical Instrument (FDA Code: LXH / 888.4540)

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

• Orthopedic Stereotaxic Instrument (FDA Code: OLO / 882.4560)

• Pneumatic-Powered Surgical Instrument Motor (FDA Code: GET / 878.4820)

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• Semi-Constrained Patellofemorotibial Knee Prosthesis (FDA Code: JWH / 888.3560)

A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).

• Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LWJ / 888.3360)

A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.

• Uncemented, Cemented Or Non-Porous Metal/Ceramic/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LZO / 888.3353)

• Vertebroplasty (Does Not Contain Cement) Injector (FDA Code: OAR / 888.4200)

A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites.