Tecres S.p.a

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Contact: Grazioli Massimo
Web: http://www.tecres.it
E-Mail:
Address: Via Andrea Doria 6, Sommacampagna, Verona 37066, Italy
Phone: +39-(45)-9217311 | Fax: +39-(45)-9217330 | Map/Directions >>

Profile: Tecres S.p.a specializes in offering orthopedic products. We focus on the research and development of bone cement. Cemex Genta bone cement contains gentamicin and is available in two versions, high & low viscosity, which can be used for the fixation of artificial joint prostheses to the host bone. These cements are indicated where there is the risk or presence of infections caused by organisms sensitive to gentamicin. High viscosity Cemex Genta bone cement can be prepared & handled rapidly and is ideal for manual application. Low viscosity Cemex Genta bone cement is ideal for application with injection device. Our spacers are temporary implantable devices. The spacers are made of gentamicin bone cement and they release antibiotic into the surrounding tissues to help the treatment of infection. The spacer have standardized mechanical and pharmacological properties. They have to be removed maximum 6 months after their implant. Spacer-K consists of two independent elements, one tibial and one femoral. The tibial component has a flat base upon which the femoral component articulates.

FDA Registration Number: 9614841
US Agent: Christinebrauer / Brauer Device Consultants, Llc
Phone: +1-(301)-545-1990 Fax: +1-(301)-545-1992 E-Mail:

19 Products/Services (Click for related suppliers)

• Antibiotic Bone Cement (FDA Code: MBB / 888.3027)

Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.

• Bone Cement (FDA Code: LOD / 888.3027)

• Cement Dispenser (FDA Code: KIH / 888.4200)

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

• 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).

• Cement Restrictor Hip Prosthesis (FDA Code: JDK / 878.3300)

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

• Curettes (FDA Code: HTF / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Disposable Surgical Instrument Kit (FDA Code: KDD / 878.4800)

• Humeral (hemi-shoulder) Metallic Uncemented Prosthesis (FDA Code: HSD / 888.3690)

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (888.3027). This device is not intended for biological fixation.

• Injection Cannula (FDA Code: FGY / 878.4200)

An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.

• Metal Femoral Hemi- Hip Prosthesis (FDA Code: KWL / 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.

• Metal/Polymer Cemented Semi-Constrained Shoulder Prosthesis (FDA Code: KWS / 888.3660)

A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder 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 humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (888.3027).

• 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.

• Methyl Methacrylate for Cranioplasty (FDA Code: GXP / 882.5300)

Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.

• Operating Room Scrub Brush (FDA Code: GEC / 878.4800)

• 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.

• 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).

• Templates (FDA Code: HWT / 888.4800)

A template for clinical use is a device that consists of a pattern or guide intended for medical purposes, such as selecting or positioning orthopedic implants or guiding the marking of tissue before cutting.

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

• Vertebroplasty Bone Cement (FDA Code: NDN / 888.3027)