Search Results

For the reconstruction of painful and/or severely disabled shoulder joints resulting from post-traumatic degenerative disease or avascular necrosis. The humeral head and neck should be of sufficient bone stock to support loading. The rotator cuff should be intact or reconstructable. The device is a single use implant intended to be used with bone cement.

The Contoured Articular Prosthetic (CAP) consists of two components, a taper post component and an articular component, that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface. The taper post component is manufactured of a Ti-6Al-4V ELI alloy per ASTM F136. The taper post has a tapering distal tip, a full-length cannulation, and a proximal female taper bore. The taper post is available in a 25mm and 30mm length to provide for variation in humeral head size. The articular component is a dome shaped component manufactured of a Cobalt-Chromium-Molybdenum alloy per ASTM F799 and ASTM F1537. The articular component has a bone contact surface that is coated with a CP Titanium coating and a polished articular bearing surface. Utilizing the drill guide provided within the CAP instrumentation set, a surgeon is able to define a working axis that is normal to the articular cartilage surface at the site of the defect. After drilling a pilot hole, the taper post is driven into place using the trial cap to ensure that the surface of the articular component will be tangent and congruent to the existing cartilage surface when seated. Using the contact probe instrument corresponding to the implant diameter, offset measurements are taken to define the topography of the patients surrounding articular surface by revolving the probe around a centering shaft coaxial to the working axis of the taper post. With these offset measurements, the surgeon is able to select the articular component from a range of sizes that will allow it to seat flush to the surrounding articular surface. Offset increments in .5mm sizes will allow for an optimal fit to the existing articular cartilage. A reamer, which matches the articular component internal geometry is used to prepare the site for the prosthetic to be implanted. This allows for a precise fit of the implant to the prepared site and minimizes bone resection, so as to provide minimal impact to any future arthroplasty procedure. The articular component is then impacted to seat the taper interlock between the two components.

Relief of pain and disability, and restoration of hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, with the bearing surface and supportive bone structure of the acetabulum being normal. The device is a single use implant intended to be used for cemented, hemi-hip, resurfacing applications only.

The Contoured Articular Prosthetic (CAP) system is intended for resurfacing of the femoral head in patients with post-traumatic degenerative disease or avascular necrosis. The natural acetabulum bearing surface and supportive bone structure should be essentially normal. The device is a single use implant intended to be used with bone cement. The CAP implant consists of two components, a fixation component and an articular component, that mate together via a taper interlock to provide stable and immobile fixation of the implant and stress bearing contact at the bone/ prosthetic interface. The fixation component is a modified cancellous screw manufactured of a Ti-6Al-4V ELI alloy per ASTM F136. The screw has a tapering distal tip, a full-length cannulation, and a proximal female taper bore. The articular component is a dome shaped component manufactured of a Cobalt-Chromium-Molvbdenum alloy per ASTM F799 and ASTM F1537. The articular component has a bone contact surface that is coated with a CP Titanium coating and a polished articular bearing surface. Utilizing the drill quide provided within the CAP instrumentation set, a surgeon is able to define a working axis that is normal to the articular cartilage surface at the site of the defect. After drilling a pilot hole, the fixation component is screwed into place using the trial cap to ensure that the surface of the articular component will be tangent and congruent to the existing cartilage surface when seated. Using the contact probe instrument corresponding to the implant diameter, offset measurements are taken to define the topography of the patients surrounding articular surface by revolving the probe around a centering shaft coaxial to the working axis of the screw. With these offset measurements, the surgeon is able to select the articular component (sized to match femoral head sizes from 40mm to 58mm) that will allow it to seat flush to the surrounding articular surface. Offset increments in .5mm sizes will allow for an optimal fit to the existing articular cartilage. A reamer, which matches the articular component internal geometry is used to prepare the site for the prosthetic to be implanted. This allows for a precise fit of the implant to the prepared site and minimizes bone resection, so as to provide minimal impact to any future arthroplasty procedure. The articular component is then impacted to seat the taper interlock between the two components. The prosthetic is intended to provide an effective means for managing pain and disability in the younger patient until a total or joint arthroplasty treatment option becomes more necessary and less likely to create an early-age-revision scenario. The prosthetic may also provide a treatment option for the older patient who may not tolerate the morbidity of a total joint arthroplasty procedure.

The Vascular Closure Device indications for use are to approximate vascular, small tubular structures, and general tissue for achieving hemostatic closure of wound or puncture site to aid healing in minimally invasive or open procedures for full body applications.

See Product Description Section on pages 17 and 18.