Endotec, Inc.

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Web: http://www.endotec.com
E-Mail:
Address: 20 Valley Street, South Orange, New Jersey 07079, USA
Phone: +1-(973)-672-9300 | Fax: +1-(973)-672-3939 | Map/Directions >>

Profile: Endotec, Inc. is a manufacturer, distributor & designer of orthopedic and maxillofacial implants. We offer products such as hip system, shoulder system, knee system & TMJ system. We offer the B-P integrated hip replacement system which includes a rich variety of component types & sizes and, therefore, offer a near custom fit for most patient pathologies. It has an integrated system that provides a great number of surgical options. In the event of the need for the revision of a component of an integrated system, the need to remove properly functioning, well fixed, components is eliminated. Our Ultracoat is a highly adherent, near diamond hard, titanium nitride (TiN) ceramic coating of about 10 microns thickness. This coating reduces wear by about two thirds and friction by about one-half compared to Co-Cr alloy heads when articulated against an UHMWPe bearing surface.

FDA Registration Number: 3006001176
US Agent: Rene Van De Zande / Emergo Global Representation Llc
Phone: +1-(512)-327-9997 Fax: +1-(512)-327-9998 E-Mail:

22 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.

• 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).

• Femoral Metal Ball Hemi Hip Prosthesis (FDA Code: LZY / 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.

• Femoral Stem Systems

• Hip Joint (Hemi- Hip) Acetabular Metal Cemented Prosthesis (FDA Code: KWB / 888.3370)

A hip joint (hemi-hip) acetabular metal cemented 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 an acetabular component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).

• 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.

• Humeral Shoulder Prosthesis (FDA Code: MJT)

• Metal Cemented Femoral Component Hip Prosthesis (FDA Code: JDG / 888.3360)

• Metal Femoral Hemi- Hip Prosthesis (FDA Code: KWL / 888.3360)

• Metal/Polymer Cemented Non-Constrained Shoulder Prosthesis (FDA Code: KWT / 888.3650)

A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 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 Constrained Hip Prosthesis (FDA Code: KWZ / 888.3310)

A hip joint metal/polymer constrained cemented or uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device prevents dislocation in more than one anatomic plane and has components that are linked together. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular component made of ultra-high-molecular-weight polyethylene with or without a metal shell, made of alloys, such as cobalt-chromium-molybdenum and titanium alloys. This generic type of device is intended for use with or without bone cement (888.3027).

• Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LPH / 888.3358)

A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.

• Non-Constrained Cemented Ankle Prosthesis (FDA Code: KXC / 888.3120)

An ankle joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (888.3027).

• 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.

• Resurfacing Femoral Hip Prosthesis (FDA Code: KXA / 888.3400)

A hip joint femoral (hemi-hip) metallic resurfacing 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 resurfacing component made of alloys, such as cobalt-chromium-molybdenum.

• 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).

• Shoulder Joint Glenoid (hemi-shoulder) Metallic Cemented Prosthesis (FDA Code: KYM / 888.3680)

A shoulder joint glenoid (hemi-shoulder) metallic cemented prosthesis is a device that has a glenoid (socket) component made of alloys, such as cobalt-chromium-molybdenum, or alloys with ultra-high molecular weight polyethylene and intended to be implanted to replace part of a shoulder joint. This generic type of device is limited to those prostheses intended for use with bone cement (888.3027).

• Spinal Pedicle Fixation Orthosis (FDA Code: MNI / 888.3070)

Pedicle screw spinal systems are multiple component devices, made from a variety of materials, including alloys such as 316L stainless steel, 316LVM stainless steel, 22Cr-13Ni-5Mn stainless steel, Ti-6Al-4V, and unalloyed titanium, that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of anchors (e.g., bolts, hooks, and/or screws); interconnection mechanisms incorporating nuts, screws, sleeves, or bolts; longitudinal members (e.g., plates, rods, and/or plate/rod combinations); and/or transverse connectors.

• Spondylolisthesis Spinal Fixation Orthosis (FDA Code: MNH / 888.3070)

• Total Ankle Systems

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