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The Symmetric™ Total Knee Augments consist of single use components intended for attachment to the Symmetric Total Knee implants during total knee arthroplasty with the following indications. 1. Osteoarthritis 2. Rheumatoid Arthritis 3. Traumatic Arthritis or correction of posttraumatic joint deformity 4. Where the use of a more conservative procedure has failed or is unacceptable. All components are for cemented use. Additional indications for use: Whenever a cone is used, a revision stem is to be used as well.

The Symmetric™ Total Knee Augments are intended to complement the Symmetric Total Knee System. The system consists of metallic wedges, stems, cones, sleeves, and offset trunnions that can be used with the Symmetric Total Knee System to provide increased bone contact and support during total knee arthroplasty when more conservative methods have failed. The FEMORAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral component. These wedges are made of Titanium 6Al-4V and have grit blasted surfaces where they are designed to be cemented to Symmetric Total Knee femoral implants and titanium plasma sprayed surfaces to provide good cemented fixation to bone. The components are available for the distal and posterior surfaces individually or combined. These wedges are symmetric so they will work on the medial or lateral side of either knee. The TIBIAL WEDGES are designed to fill voids remaining in the peripheral bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the tibial component. These wedges are made of Titanium 6A1-4V and are designed for cemented fixation to Symmetric Total Knee tibial implants. The titanium plasma sprayed surfaces provide increased fixation for bone cement. The components are available in flat and wedged designs, and are able to be used on the medial or lateral side of the symmetric trays. The TIBIAL and FEMORAL Cones are designed to fill voids remaining in the central bone stock after the removal of diseased and damaged bone, and to provide indirect bone support for the femoral or tibial component. These cones are symmetrically designed components designed for cemented fixation around the trunnion or revision stem of a Symmetric total knee implant. The cones are made of Titanium 6Al-4V and are internally grit blasted for cement fixation against the implant and externally plasma sprayed to provide increased cemented fixation to bone. The OFFSET TRUNNIONS are designed to be attached to the trunnion of the femoral or tibial component utilizing a Morse Taper, and then has a Morse Taper of its own to receive a revision stem. The offset stems are made of Titanium 6A1-4V, and are designed to provide adjustments in stem position with respect to the primary implants trunnion, allowing the stem to line up with the patient's medullary canal more effectively. The COATED AND PARTIALLY COATED REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6Al-4V and are titanium plasma sprayed to provide increased fixation. The RECTANGULAR REVISION STEMS are designed to be attached to the trunnion of the femoral or tibial component utilizing the Morse Taper. The stems are made of Titanium 6AI-4V and are available in non-coated and titanium plasma spray coated styles. The rectangular shape is designed to provide cortical bone support while reducing cancellous bone loss.

The wires are intended for use in the fixation of bone fractures, for bone reconstruction, or as a guide/aid for the insertion of other medical devices.

The device consist of various diameter and length wires for use in the fixation of bone fractures, bone reconstruction, or as a quide or aide for insertion of other medical devices. The wires are made of 316LVM Stainless Steel.

Indications For Use: Triple arthrodesis Isolated rearfoot arthrodesis Midfoot arthrodesis Comminuted trauma Diabetic Charcot reconstruction Most foot pathology not requiring fixation above the ankle

The E-Z Frame Surgical Boot is manufactured of light weight stable materials to allow the surgeon to stabilize the foot at or below the ankle for post surgical conditions. Presently liizarov or Sheppard Rings are used for this purpose and require multiple avenues of surgical intervention in the tibia to stabilize the distal support ring. With the E-Z Frame system a boot is stabilized on the distal leg (tibia) and further stabilized to the distal ring about the foot with carbon fiber rods that are attached to the boot and ring respectfully. Light weight materials are employed using 6061 Aluminum, ABS plastic, carbon fiber rods, FR10/11 laminate and small ASTM F 17-4 Stainless Steel Fixtures. The foot is stabilized to the distal ring using Kirshner Wires (K-Wire) purchased from PROMEX of Indianapolis, IN under 510 K: K960023. The boot utilized to stabilize the device on the tibia is purchased and modified from Darco International of Virginia.

OSTEOARTHRITIS RHEUMATOID ARTHRITIS TRAUMATIC ARTHRITIS WHERE THE USE OF A MORE CONSERVATIVE PROCEDURE HAS FAILED OR IS UNACCEPTABLE INTENDED FOR NON-CEMENTED USE SINGLE USE ONLY

The Signal Medical Corporation HHS Acetabular Component is manufactured of ASTM I-136 or F-75. The design is made available in twelve (12) sizes ranging from 48mm to 70mm, in two mm increments. The cup is coated with an F-67 sintered beaded surface for F-136 or F-75 beads for an F-75 cup to enhance bone ingrowth. The device is designed in three models, one with three circumferentially spaced pins or spikes at 120 degree intervals to provide for a primary skeletal fixation and reduce the chance of rotation, one with screw holes and one with both screw holes and spikes. The ultra high molecular weight polyethylene inserts, ASTM F648, are secured to the acetabular shell using a crown-taper fit. They are designed to accept 28mm femoral heads on their inside diameter from 48mm to 70mm and 32mm femoral heads from 54mm to 70mm. This device is intended for single use only.

Osteoarthritis. Where the use of a more conservative procedure has failed or is unacceptable. The device is intended for non-cemented use.

The Signal Medical Corporation Great Toe Implants are manufactured from ASTM F75 Cobalt Chrome. The porus coating is ASTM F75 sintered beads, -45+60 mesh. The device is intended for non-cemented use. The stem of the device is intended to be inserted into the proximal end or base of the first phalangel bone. The convex surface of the implant is intended to articulate with the distal end or head of the first metatarsal bone. The design is made available in multiple sizes equivalent to the toe implants in the Townley Great Toe Joint 510K (K911378) and the Zimmer Great Toe 510K (K823405).

- Osteoarthritis - Rheumatoid Arthritis - Traumatic Arthritis - Where the use of a more conservative procedure has failed or is unacceptable.

The Signal Medical Corporation 28mm Ceramic Femoral Heads are manufactured from zirconium oxide. The design is made available in three (3) sizes identical to the cobalt chrome femoral heads in the Signal Medical Corporation 510K (K971681) (-3.5, 0, +3.5). These ceramic femoral heads should only be used on the Signal Medical Corporation (SMC) femoral component of the hip, and should never be resterilized.

This femoral component of the hip is indicated for use in patients with: 1 - Osteoarthritis - 2 Rheumatoid Arthritis - 3 Traumatic Arthritis and when the use of a more conservative procedure has failed or is unacceptable.

The Signal Medical Corporation Femoral Component of the Hip is manufactured with cobalt chromium alloy (ASTM F-75). The design is made available in four (4) sizes ranging from 10.5mm to 15mm. The stem portion of the femoral component is essentially identical to the DePuv AML Femoral Component (K852198) and the BioPro Horizon Femoral Component (K962769). The collar will be available in two different angular settings of 20 degrees to the horizontal and 35 degrees to the horizontal. The device will be offered with and without a sintered beaded surface, as depicted on the engineering drawings. The taper on the trunnion is a standard 5.708 degree angle as found on the Whiteside Biomechanics (K961625) and the StelKast Proform Cemented Femoral Component (K951083). The device has a circumfrential collar to load the bone on the cortical arc and distribute the compressive load of the implant as proximally as possible. The stems distal to the collar are essentially identical in geometry and size as the DePuy AML (K852198) and the BioPro Horizon (K962769). The non-sintered beaded surface device will have a 5mm hole in the distal tip of the implant to accommodate a cement centralizer from the StelKast Corporation (K951083). This device is designed for cemented use only in the non-porous coated version. With the porous sintered beaded surface, the device is designed for both cemented and non-cemented press-fit use.

Osteoarthritis Rheumatoid Arthritis Traumatic Arthritis Where the use of a more conservative procedure has failed or is unacceptable

The Signal Medical Corporation Acetabular Component is manufactured of forged titanium, 6 aluminum, 4 vanadium, ELI metal (ASTM F-136, F620). The design is made available in thirteen (13) sizes ranging from 48mm to 72mm. The outside diameter of the cup is coated with a commercially pure titanium sintered beaded surface to enhance either bone ingrowth or cement adherence depending on the choice of the surgeon. Also three circumferentially spaced pins or spikes at 120 degree intervals provide for a primary skeletal fixation and reduce the chance of rotation. The inside assembly of the device and the polyethylene insert are identical to the StelKast Corporation Proform Porous Acetabular Assembly (K950827). The inside diameter system provides a locking ring and three pegs that secure the ultra high molecular weight polyethylene articular surface in place. The acetabular inserts are identical to the StelKast Corporation (K950827) inserts. The ultra high molecular weight polyethylene inserts are secured to the acetabular shell as described above and are designed to accept 28mm femoral heads on their inside diameter.