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Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. A. Proximal femoral fractures. B. Avascular necrosis of the femoral head. C. Non-union of proximal femoral neck fractures. D. Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities. UNISYN stems used with roughened and plasma coated bodies are intended for cemented or uncemented use. UNISYN stems used with plasma/HA or HA coated bodies are intended for uncemented use only.

The UniSyn Hip System was originally cleared as a modular hip system for Hayes Medical under the name "Triton", modifications to the system were cleared in a subsequent submission by Hayes under the UniSyn name. Hayes Medical changed its name to Consensus Orthopedics in 2008. This system consists of three primary components: the neck, the body, and the stem. This submission is to addition of a set of modified ("Plus") stems. These minor modifications in body thickness are designed to allow for better contact between the implant and the inner surface of the medullary canal during revision surgery. The sizes of stems offered with the modified design are within the ranges previously cleared for the UniSyn system. The Plus stems are offered in neutral or +1 mm styles, short or long, in 10 to 20 mm diameters, and lengths from 110 to 210 mm. There is no change to the manufacturing, packaging, or sterilization processes. This change will not affect the indications for use nor any of the labeling.

The indications for the Trinity Acetabular System as a total hip arthroplasty include: - o Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis - Rheumatoid arthritis o - o Correction of functional deformity - Developmental dysplasia of the hip (DDH) or congenital dysplasia of the hip (CDH) o The Trinity Acetabular System is intended for cementless use only.

The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell (48mm through 68mm in 2mm increments) for use with ultra high molecular weight polyethylene (UHMWPE) liners (28mm and 32mm inner diameters in neutral, +4mm offset, EPW and 10° hooded designs) and a dedicated range of 28mm and 32mm modular 12/14 taper femoral heads providing ceramic (i.e., zirconia and Biolox delta in the USA) or metal on UHMWPE articulation for use in total hip replacement procedures using Corin titanium femoral stems with a 12/14 taper connection. The acetabular shell is coated with a rough titanium plasma spray with an additional top layer of electrochemically deposited calcium phosphate (Bonit™). The acetabular shell is provided with screw holes permitting the use of dedicated titanium bone screws to provide additional fixation if required. Titanium occluders are provided to occlude unused screw holes and an apical introducer hole. The purpose of this submission is to modify the labeling for the Trinity Acetabular System to include additional Corin titanium femoral stems with a 12/14 taper connection as compatible components, intended for use with the Trinity Acetabular Cup and Liner and the Trinity CoCr Femoral Heads. The Trinity Acetabular System is intended for use in total hip arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged hip joint articulation where there is evidence of sufficient sound bone to seat and support the components.

All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment. Components of Exactech Hip Systems are also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Cemented femoral stems and cemented acetabular cups are intended for cemented fixation only. Press-fit femoral stems and acetabular cups are intended for press-fit fixation. Press-fit components without hydroxyapatite (HA) coating may also be used with bone cement at the discretion of the surgeon. Femoral heads and endoprostheses are intended for use in cemented and press-fit applications.

The proposed Novation CFS Press-Fit and Cemented Femoral Stems are modifications to the existing Novation Press-Fit and Novation Cemented Plus femoral stem devices previously cleared in K042842 and K083392, respectively. The proposed Novation CFS Press-Fit stem has the same general design features as the predicate device. The modifications include the addition of a calcar collar, grit-blast body, and a satin finish neck. The proposed CFS Cemented stem has the same general design features as the Novation Cemented Plus stem, but the proposed stems are cast instead of forged cobalt chrome alloy and the neck is a satin finish. Both proposed stems contain a modified 12/14 femoral head taper connection. The proposed stems mate with previously cleared 12/14 Co-28Cr-6Mo femoral heads (K041906), Zirconia ceramic femoral heads (K050398 and K060107) and 12/14 Unipolar Sleeves (K010081). The proposed stems are not compatible with alumina ceramic femoral heads (K032964 and K051682). The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities: · the same indications for use · similar design features · incorporate the same materials · the same shelf life · are packaged and sterilized using the same materials and processes.

The Metha® Short Stem Hip System (uncemented, press-fit fixation) is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement; patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with acute femoral neck fractures.

The Metha® Short Stem Hip System XL Femoral Head is manufactured CoCrMo and conforms to ISO 5832. The XL femoral head is offered in two diameters (28mm and 32mm). The CoCrMo head allows the surgeon a further option to meet the patient's needs.

Indications for use of the ConsensusTM Hip System or UNISYN™ Hip System - A) Significantly impaired joints resulting from rheumatoid, osteo, and post-traumatic arthritis. - B) Revision of failed femoral head replacement, cup arthroplasty or other hip procedures. - C) Proximal femoral fractures. - D) Avascular necrosis of the femoral head. - E) Non-union of proximal femoral neck fractures. - F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa vara, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, osteoporosis, pseudarthrosis conversion, and structural abnormalities Acetabular components are indicated for cemented and cementless use. Consensus femoral stems are indicated for cemented and cementless use. UniSyn femoral stems are indicated for cementless use only. HA coated implants are indicated for cementless use only.

The Consensus Hip 36mm CoCrMo (ASTM F799 or ASTM F1537) femoral head is offered with four different offsets, -5mm, neutral, +5mm and +10mm. Other than size, it incorporates no new design features. Female head taper is identical to the head taper design for the cleared devices. The 36mm acetabular insert is offered in sizes 54 - 68 (2 mm increments), in neutral, 10 and 20 degree hooded configurations. Material for all 36mm insert sizes is crosslink UHMWPE (ASTM F648). Hooded configurations incorporate a titanium alloy x-ray marker (Ti 6Al-4V ELJ ASTM F136). Insert locking detail of the subject device is identical to the locking detail of the cleared devices.

This device is indicated in hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - 1. Non-inflammatory degenerative joint disease such as osteoathritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - 2. Inflammatory degenerative joint disease such as rheumatoid arthritis; - 3. Correction of function deformity; - 4. Revision procedures where other treatments or devices have failed; and - 5. Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. This device is a single use implant and intended for cementless use only.

The U2 Hip Stem, Ti plasma spray is composed of a metallic femoral stem, which is designed to articulate with commercially available U1 and U2 acetabular components and They are manufactured from titanium alloy (ASTM F620). The stems femoral heads. are designed to provide secure fit and fixation in revision hip arthroplasty for anteroposterior bone loss, calcar area defects, metaphyseal bone loss situation. The U2 Hip Stem have a 130° neck angle and Morse taper to receive modular femoral heads. The U2 Hip Stem are available in with collar and collarless types. Each type is available in two lengths, 180mm and 230mm, and 7 diameters: 11mm, 12mm, 13mm, 14mm, 15mm, 16.5mm, 18mm. Distally, the stem is cylindrical with a polished bullet shape tip. The 180mm U2 Hip Stem is available as a straight stem, the 230mm femoral stem has an anterior bow for left and right specific applications. The U2 Hip Stem are fully coated with CP Ti (ASTM F1580). The coating is sprayed with CP Ti powder in thickness 500 um +/-100 um using 200~350 um powder to establish a rough surface for press-fit fixation. This device is a single use implant and intended for cementless use only.

Indications for use of the UNISYN™ HIP SYSTEM A) Significantly impaired joints resulting from rheumatoid, osteo, and posttraumatic arthritis. B) Revision of failed femoral head replacement, hip arthroplasty or other hip procedures. C) Proximal femoral fractures. D) Avascular necrosis of the femoral head. E) Non-union of proximal femoral neck fractures. F) Other indications such as congenital dysplasia, arthrodesis conversion, coxa magna, coxa plana, coxa vara, coxa valga, developmental conditions, metabolic and tumorous conditions, osteomalacia, pseudarthrosis conversion, and structural abnormalities

The Body, HA Plasma, Modular Hip is part of the Unisyn modular hip system. The system consists of three parts; the neck, the body, and the stem. There are thirty-three different proximal bodies with six different cone diameters with multiple medial projections for each size. There are also cone-only bodies with and without collars. The surface of the body is plasma sprayed with a secondary coating of hydroxylapatite.

The Excia Hip System is intended to replace a hip joint. The device is intended for: - Patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fractures of the femur. - Patients with congenital hip dysplasia, protrusion acetabuli, or slipped capital femoral . ephiphysis - Patients suffering from disability due to previous fusion ● - Patients with acute femoral neck fractures . The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti. With a Ti. Plasma spray.

The Acetabular Cups (Plasmacup® NSC and MSC) are manufactured from Ti. and are offered with a plasmapore® coating. The Plasmacup® is offered in two designs: NSC and MSC (no holes or multiple holes). Both designs are available in sizes ranging from 40mm - 68mm. The new Plasmacup® Acetabular Cups are a line extension to the existing Excia Total Hip System. The Excia Hip System is available with two femoral stems. One is manufactured from CoCr and intended for cemented fixation. The other femoral stem is for uncemented fixation and is manufactured from Ti. With a Ti. Plasma spray.

The BetaCone is intended for non-cemented use to replace the anatomy of the femur in cases of total hip replacement. It is indicated in the treatment of the following: - Patient conditions of noninflammatory degenerative joint disease, e.g., avascular necrosis and osteoarthritis; and inflammatory joint disease, e.g., rheumatoid arthritis; - Those patients with failed previous surgery where pain, deformity, or dysfunction persists; and - Revision of a previously failed hip arthroplasty.

Both the BetaCone and the predicate Encore, CLS, and Alloclassic Hip Stems use titanium alloy straight, tapered stems to replace the femur in hip replacement procedures. The BetaCone is fabricated from Ti-6Al-4V titanium alloy. BetaCone stems are available in 9 standard and 9 XL sizes. with lengths ranging from 135 to 175 mm. The BetaCone stem has a rectangular cross-section slightly rounded in both planes. BetaCone XL neck lengths are 5 mm longer than standard stem neck lengths. The Beta Cone neck angle is 126°. A 12/14 taper connects with Link's prosthesis heads using the same size taper. The BetaCone is compatible with Link standard acetabular cups. The BetaCone stem is designed for uncemented, press-fit fixation. A proximal trochanter fin supports proximal press-fit fixation.

This device is used for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: - Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; - Inflammatory degenerative joint disease such as rheumatoid arthritis; - Correction of function deformity; - Revision procedures where other treatments or devices have failed; and - Treatment of nonunion, femoral neck, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques. The U2 Acetabular Components are designed for uncemented application and single use only.

The U2 Acetabular Component is designated to be used with United U1 hip stem (K994078) and U2 hip stem (K003237) of total hip replacement. It is a modular type of product system. The U2 Acetabular Component has 14 sizes, hemispherical design and without or with clustered bone screw holes for variable screw locking angle. The metallic shell is manufactured from forged Titanium alloy (ASTM F620) and its outer surface has two types of coating. Ti plasma spray and IIA/Ti plasma spray. The acetabular liner is machined from extruded UHMWPE bars (ISO 5834/1) and its minimum thickness is 4 18 mm to reduce contact stress. If supplemental bone screw fixation is deemed necessary, Titanium Cancellous Bone Screws (ASTM F136) can be inserted through the screw holes without interfering with the seating of the acetabular liner.