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Wright Medical total hip systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use - 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 functional deformity; and, - revision procedures where other treatments or devices have failed. Rough grit blast surfaces are intended for uncemented arthroplasty. The PROFEMUR® Z Revision Hip Stem is intended for cementless hip arthroplasty.

Design features of the subject stems are summarized below: - Cementless modular stems - Available in 9 sizes - Manufactured from Titanium alloy with a heavy grit blasted surface. The subject device is available in 9 sizes (from size 3 to 11). Although the proximal geometries are identical to the predicate from size 3-9, the distal stem length has increased, with two larger sizes (10 and 11) introduced.

Total hip replacement for patients with: - Noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, . osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis. - . Femoral neck fractures. - . Failed previous surgery where pain, deformity, or dysfunction persists. - Revision of previously failed hip arthroplasty. . Hemi-hip replacement for patients with: - Femoral neck fractures. . This femoral stem is for cementless use only.

The CLS Brevius Stem with Kinectiv Technology is a modular, titanium alloy femoral stem designed to replace the proximal femur in total or hemi-hip arthroplasty. It is a wedge-shaped, collarless design with a proximal-to-distal taper and a trapezoidal cross-section. The proximal portion of the stem contains a tapered female junction to allow for attachment to Kinectiv Technology modular necks and features for attachment of insertion/extraction instrumentation.

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Porous coated components are intended for uncemented biological fixation.

The TaperIoc® Complete Microplasty Stems are an update to the existing TaperIoc® Microplasty Stems and are designed to replace the patient's natural hip, femoral neck, and head, due to disease or accident. The Taperloc® Complete Microplasty Stems will combine the design features of the Taperioc® Complete full-length stems to the shortened design of the existing Taperloc® Microplasty Stems. These design features include: a reduced neck angle, shorter/longer neck lengths, reduced Type 1 taper geometry with neck flats, polished neck, standard and high offset versions, two distal profiles, and an updated insertion hole. Stem sizes ranges are within the ranges of legally marketed predicates. The substrate material is Ti-6AI-AV, ASTM F-136. The proximal intramedullary region is sprayed with porous plasma spray.

The PROFEMUR® E Cementless Hip Stem is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications For Use: The PROFEMUR® E Cementless Hip Stem is indicated for use in total 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 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 PROFEMUR® E Cementless Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

The modular PROFEMUR® E Cementless Hip Stems hip stem is an uncemented distal femoral implant designed to couple with Wright Medical Technology's PROFEMUR® CoCr modular necks. The stem design was developed from the previously marketed PROFEMUR® Z Hip Stem (STEM) K021346) and possesses the identical modular neck taper socket and is made of the identical Titanium alloy (ASTM F620) as previous hip stem designs by Wright. The PROFEMUR® E Cementless Hip Stem is made of the same Titanium alloy and features a corundum blast surface finish similar to the PROFEMUR® Z Hip Stem (K021346). The PROFEMUR® E Cementless Hip Stem shares the rectangular cross-section of the predicate devices, and is designed to feature additional tapered lateral fins on each stem side.

The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem is indicated for use in total hip arthroplasty 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 functional deformity; and. - revision procedures where other treatments or devices have failed The PROFEMUR® Z Titanium Plasma Sprayed Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of an uncemented total hip arthroplasty.

The modular PROFEMUR® Z Titanium Plasma Sprayed hip stem is an uncemented distal femoral implant designed to couple with Wright Medical Technology's PROFEMUR® CoCr modular necks. The stem design was developed from the previously marketed PROFEMUR® Z Hip Stem ('STEM' K021346) and features the identical modular neck taper socket and is made of the identical Titanium alloy (ASTM F620) as previous hip stem designs by Wright. The PROFEMUR® Z Titanium Plasma Sprayed Hip Stem features the identical substrate cross-sectional geometry as the PROFEMUR® Z Hip Stem (K0213146) with the addition of titanium plasma spray coating conforming to ASTM F1580 applied according to WMT specifications which covers the proximal 1/3 of the stem.

The GLADIATOR® Plasma Classic Hip Stem is intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. Indications for Use: 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 GLADIATOR® Plasma Classic Hip Stems are intended for use during uncemented hip arthroplasty.

The GLADIATOR® Plasma Classic Hip Stem is a straight uncemented stem, and features a rectangular cross-section, proximally a trapezoidal section manufactured from base material of Titanium alloy (Ti6Al4V - ASTM F620, equivalent to ISO 5832-3). The profile tapers vertically both in frontal and lateral view, to achieve fixation stability in three planes. The stem possesses a 0.5mm thick titanium plasma spray coating on the proximal third of the stem surface, conforming to ASTM F1580. The stem length ranges from 125 mm in length, is available in 10 sizes (1-10), and features 0.5mm thick titanium plasma spray on the proximal third of the stem surface. The stem is available in standard and extended neck offsets.

The Taperloc Complete hip stems are intended for uncemented biological fixation. This is the same intended use as the predicate Taperloc® stems cleared in K101086. Indications For Use: 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Porous coated components are intended for uncemented biological fixation.

The Taperloc® Complete hip stems are a line extension of the legally marketed Taperloc® Complete stems cleared in K101086.

Indications for the Arcos™ Interlocking Distal Stem include: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. The Arcos™ Interlocking Distal Stems are single-use implants, intended for uncemented applications.

The Arcos™ Interlocking Distal Stem was designed to be a part of the Arcos™ Modular Femoral Revision System, a modular system using interchangeable stems and proximal bodies commonly seen in femoral revision surgery. The proximal bodies consist of broached, calcar-replacing, and cone-style implants, made from Ti-6Al-4V (ASTM F-136) and featuring a roller hardened taper, is fully porous coated (Ti-6AL-4V, ASTM F-1580) with a fine buffed finish on the bullet-tip. The distal stems will be offered in a range of diameters from 15-26mm and lengths of 200mm, 250mm, and 300mm. The stems are offered in porous cylindrical with proximal taper and splined tapered designs. The stem provides holes for interlocking screws to provide temporary rotational stability. The system also includes auxiliary implants to aid in fixation. The system is intended for uncemented applications

The Compress® Segmental Femoral Replacement System is indicated for: 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. 2. Tumor resections. 3. Revision of previously failed total joint arthroplasty. 4. Trauma. The Compress® Segmental Femoral Replacement System components are intended for uncemented use.

The Compress® Seqmental Anti-Rotation Spindles are not joint replacements but rather a method of fixing a segmental joint replacement to the patient's host bone. It utilizes the same spring-enhanced, stress-sharing design as the predicate Compress® Segmental Femoral Replacement System to generate stress on the host bone which helps prevent bone atrophy and promotes bone growth. It is intended to be used in conjunction with a knee or hip implant. The complete device consists of an anchor plug, a spindle and either a proximal or distal femoral component. This 510(k) addresses modifications to the spindles. Holes are being added to the collar of the spindles to allow placement of pins to prevent rotation of the initial weeks following implantation. Additional sizes of spindles are also being added to the line.

Indications for the Biomet® Modular Revision Femoral System Include: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. 5. Revision of previously failed total hip arthroplasty. The Biomet® Modular Revision Femoral System hip components are single-use implants, intended for uncemented applications.

The Blomet® Modular Revision Femoral System is a comprehensive, press-fit revision stem design that provides the surgeon with multiple styles of modular proximal and distal bodies for reconstruction of various defects commonly seen in femoral revision surgery. The proximal bodies will consist of broached, calcarreplacing, and cone-style implants. The system also includes auxiliary implants to aid in fixation. A single set of instrumentation is provided for all styles. The system is intended for uncemented applications