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The Biocore9 Femoral Resurfacing Head Component, is indicated for the treatment of painful hip arthritis due to post-traumatic arthritis, or rheumatoid arthritis, as well as painful hip arthroplasty when sufficient femoral head and neck stock exist to stabilize a resurfacing femoral head. The Biocore9 Femoral Resurfacing Head Component is intended for cemented use only. This device is intended for hemi-arthroplasty only.

The Biocore9 Femoral Resurfacing Head component is a non-constrained orthopedic implant intended to replace the articular surface of the existing femoral head in the patient's hip joint. The Biocore9 Femoral Resurfacing Head Component is intended for in the reconstruction of painful and/or severely disabled hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, or previously failed prosthesis. Sufficient bone stock on the femoral head and neck is necessary to stabilize a resurfacing femoral component. This device is intended for cemented use only. Components are available in thirteen sizes with available outside diameters 39.5, 41, 42.5, 47, 49, 51, and 52.5 mm. The Biocore9 Femoral Resurfacing Head Component is manufactured from Ti-6Al-4V alloy (ASTM F136-13) with a Titanium Nitride (TiN) thin film ceramic coating. The titanium nitride coating is an inert, highly adherent, near diamond-hard surface coating. The Femoral Resurfacing component is axisymmetric with a truncated spherical shell and a tapered central alignment stem. The component consists of a thin-walled spherical shell. The internal surface of the spherical shell is covered with a porous coating consisting of titanium beads. The stem is not porous coated.

MicroPort total hip systems are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed The MicroPort total hip systems devices are single use only devices.

The subject devices are a variety of hip joint replacement prostheses. The components for these systems include an acetabular shell, acetabular liner, fixation screws, femoral head, femoral stem, modular neck, proximal body, centralizers, bone plugs, and neck sleeves. These components can be utilized in a variety of configurations to assemble the final construct. The femoral and acetabular components are manufactured from a variety of materials which include cobalt-chromium-molybdenum alloy, titanium alloy, unalloyed titanium, alumina ceramic, Alumina Matrix Composite ceramic (Biolox Delta), polymethylmethacrylate (PMMA), and ultra high molecular weight polyethylene (UHMWPE), all of which conform to ASTM or ISO standards, or internal standards. The only changes to the subject hip systems are updates to the labeling of the devices. Specifically, the package inserts and package labels are being updated to include MR Conditional language and symbols. The subjects are identical to the predicates in all aspects except for the labeling updates.

The Cormet Cementless Resurfacing Femoral Head is indicated for hemi hip resurfacing arthroplasty in patients with non-inflammatory degenerative joint disease, including osteo and rheumatoid arthritis, post traumatic disease and avascular necrosis. It is indicated for relief of pain and disability, and to restore hip function within patients who have radiographic evidence of good bone stock in the femoral head and acetabulum, the bearing surface and supportive bone structure of the acetabulum being normal. It is intended for patients having deformities of the hip that do not lend themselves to conventional total hip replacement such as: - previously failed femoral osteotomy, . - early deformities of the proximal end of the femur. . The Cormet Cementless Resurfacing Femoral Head is indicated for cementless use only.

The Cormet Cementless Resurfacing Femoral Head is a femoral component manufactured from cast cobalt-chromium-molybdenum (Co-Cr-Mo) alloy complying with the requirements of ASTM F75 and ISO 5832-4. It is designed to replace the outer surface of the natural femoral head for hemi hip arthroplasty and articulates against the natural acetabulum. The component has a central stem and three internal splines to provide anti-rotational stability. The inner, bone contacting surfaces of the component have coatings of plasma sprayed titanium and hydroxyapatite for cementless fixation. The Cormet Cementless Resurfacing Femoral Head is not approved for use with an acetabular component in the US.

The CONSERVE® Pressfit Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia. CONSERVE® Pressfit Femoral Resurfacing Component is intended for non-cemented use

The design features of the CONSERVE® Femoral Resurfacing Component are summarized below: - Manufactured from Cobalt Chrome Alloy - 12 Sizes in 2mm increments - Plasma Spray undersurface

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis. The device is a single use implant intended for press-fit application.

The ReCap® HA Press-Fit Femoral Resurfacing Head is a singleuse, hemi-hip femoral resurfacing head, designed to replace the outer surface of a natural femoral head, while preserving as much natural bone as possible.

FOR HEMI-HIP RESURFACING ARTHROPLASTY: The Durom Hip Resurfacing system femoral component, when used for hemi-hip arthroplasty, has been designed for cemented use in patients who are likely to outlive a conventional hip prosthesis. Femoral hip resurfacing hemi arthroplasty is most appropriate for patients with good bone quality in the femoral head and acetabulum, where the bearing surface and supportive bone structure of the acetabulum is normal, and where acetabular replacement is neither required nor desirable. Such patients will generally be under the age of 65. - Non inflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis if remaining bone stock is adequate, and osteoarthritis - Inflammatory joint disease (IJD), e.g. rheumatoid arthritis - Joint replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely crippled patients with multiple joint involvement for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives Additional indications include other abnormalities where major pathology affects the femoral head; where the bearing surface and supportive bone structure of the acetabulum is normal; and where acetabular replacement is neither required nor desirable * WARNING: The Durom Femoral component is not approved for use with the Durom Acetabular cup for total hip surface replacement arthroplasty in the USA.

The Durom® Hip Resurfacing System femoral component consists of a monoblock head and slim-line femoral guide pin. The head is an extended hemisphere (greater than 180°). It is available in 12 sizes with Outside Diameters (ODs) ranging from 38mm to 60mm. The spherecity of the head is tightly controlled to less than 10 microns. The underside of the head has recesses for controlled pressurization of cement into the cancellous bone, and for rotational stability after implantation.

The CONSERVE® Femoral Resurfacing Component is indicated for use in hemi resurfacing for reduction or relief of pain and/or improved hip function in skeletally mature patients with non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusion acetabuli, and painful hip dysplasia. The CONSERVE® Femoral Resurfacing Component is indicated for cemented use only.

The design features of the CONSERVE® Femoral Resurfacing Component are summarized below: - Manufactured from Cobalt Chrome Alloy . - 11 Sizes in 2mm increments .

Indications for use include a severe disabling and/or painful hip associated with the following indications: 1) Osteoarthritis, 2) Traumatic arthritis, 3) Rheumatoid arthritis, 4) Advanced avascular necrosis, 5) Congentital hip dysplasia, and 6) Slipped captial femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

The all-metal cobalt chrome TARA Resurfacing device is a single unit component and is porous coated on the inner cylindrical wall and ceiling only. The cobalt chrome porous coating is a -45 +60 Mesh x .030" thick surface coating. The all-metal TARA is only avaiable in the short stem version, again with nine head sizes from 38mm to 55mm in 2 mm increments. The all-metal TARA is fixed to the bone with cement.

The DePuy ASR™ Resurfacing Femoral Heads are intended for cemented use in hemiarthroplasty (partial hip replacement procedure). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acctabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

The DePuy ASR™ Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a onepiece cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a central guide pin. The implants range in sizes 39mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the ninimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum.

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis, and rheumatoid arthritis. The device is a single use implant intended for press-fit application.

The Press-Fit Head Resurfacing device is designed to replace the outer surface of the femoral head while preserving as much natural bone as possible. The device retains the diameter of the natural femoral head and articulates aqainst the natural acetabulum (hemi-hip). The device is manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-75. It has a highly polished outer surface and a titanium plasma spray coated inner surface. A central post is provided for stabilization. The device is available in diameters of 38mm to 60mm, in one-millimeter increments.