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The Prime Acetabular Cup System 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. Shells with BIOFOAM® coating are intended only for uncemented arthroplasty.

MicroPort is introducing the Prime BIOFOAM® Multi-Hole Shells as a line extension of its existing Prime Acetabular System (K170444, K171181, K180798, and K181598). The subject implants are single use only, are provided sterile, and are to be implanted only by orthopedic specialists in an operating room setting. Associated instrumentation is reusable, provided nonsterile, and are to be used only by orthopedic specialists in an operating room setting. The Prime BIOFOAM® Multi-Hole Shell includes 10, 12, or 14 screw hole variations. The subject acetabular shells can be used with existing MicroPort devices listed in Section G, Table 3 to form a complete total hip system. - Multi-Hole Acetabular Shells - Material: Ti alloy conforming to ASTM F620 O - Coating: Commercially Pure Ti Foam conforming to ASTM F67 O (BIOFOAM®) - Outer diameters: 42mm to 68mm with 2 mm increments O - Variants: 10, 12, or 14 screw holes O - Sterilized using Gamma Radiation O

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

The R3 HA Coated Acetabular Shells are line additions to the existing R3 Acetabular System. The R3 HA Coated Acetabular Shells have the same design as the existing R3 Shells. The difference is the addition of HA coating. The R3 Ha Coated Acetabular Shells will be offered in No-Hole, 3-Hole and Multi-Hole design options. The R3 HA Coated Acetabular Shells will be used with existing R3 Acetabular Liners and accessories and existing Smith & Nephew femoral heads and femoral stems.

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection: fracture-dislocation of the hin; and correction of deformity. The R3 Acetabular System is for single use only and is intended for cementless use.

The subject of this Special 510(k) is the R3® Anteverted Liners. The subject R3 Anteverted Liners are a line extension to the R3 XLPE Liners that were cleared under premarket notifications K113848 and K093363. The R3 Anteverted Liners have same overall design, indication for use and material as the predicate R3 XLPE liners. The subject R3 Anteverted Liners feature a 20° anteverted, or "face changing", entry angle to the articulating surface (Inner diameter). Also, a variable angle chamfer/bevel was added on the rim of the liner. The R3 Anteverted Liners have +4mm lateralized inside Diameter, 20° andle, and identical locking mechanism as the predicate R3 XLPE Liners, cleared under K113848 and K093363. The R3 Anteverted Liners are available with Inner diameter (ID) sizes 28, 32, 36, 40 and 44mm and the Outer Diameter (OD) sizes ranging from 44 to 76-80mm.The R3 Anteverted Liner is manufactured from 10MRAD Cross-linked Polyethylene (XLPE) confirming to ASTM F648, as the predicate R3 XLPE Liners cleared under a premarket notification K113848 and K093363. The R3 Anteverted Liners are provided sterile and is intended for single use only.

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. Total hip systems may be indicated for use (i) with bone cement , (ii) without bone cement , or (ii) for use with or without bone cement.

The subjects OXINIUM DH Femoral Heads are metal alloy devices processed via a proprietary oxidation process and are designed as a component to replace a hip joint. The subject OXINIUM DH Femoral Heads are designed for use with existing 510(k) cleared products consisting of Smith & Nephew hip stems, acetabular shells and liners and will articulate against existing acetabular shell and liner constructs. The subject Femoral Heads are comprised of Oxidized Zirconium manufactured from wrought Zirconium (Zr) -2.5 Niobium (Nb). The purpose of this 510(k) submission is to add additional OXINIUM DH femoral heads to the Smith & Nephew Total Hip System.

The DYNASTY® BIOFOAM® Shells are intended for use in cementless 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. The DYNASTY® BIOFOAM® Shell is intended for cementless hip arthroplasty.

Design features of the shells are summarized below: - Shells manufactured from Titanium alloy substrate, coated with BIOFOAM® coating ● manufactured from commercially pure (CP) titanium - Solid shell sizes: 46mm-68mm outer diameter - Three different hole patterns: - 10-hole shell sizes: 46mm-76mm outer diameter - 3-hole shell sizes: 46mm-68mm outer diameter - 5-hole shell sizes: 46mm-50mm outer diameter

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Traditional 510(k) premarket notification is a modification to the R3 22-36mm XLPE Acetabular Liners. The liners were originally cleared under K070756. Four vents have been added to the locking detail of the subject liners. The vents have been added to allow for improved fluid egress from behind the locking beads in an effort to minimize the potential for difficulty seating the liners during aggressive impaction.

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Abbreviated Premarket Notification are R3 XLPE Acetabular Liner line additions in an anteverted liner option. Anteverted liners modify the face opening of the acetabular liner component. The subject devices are intended to be used in conjunction with existing R3 Acetabular Shells, and they are intended to articulate against appropriately sized, existing Smith & Nephew femoral heads. They are manufactured from XLPE material and will initially be offered in inner diameters of 32 and 36mm and outer diameters of 48-72/74mm. R3 XLPE Acetabular Liners have previously been cleared for market under premarket notifications K070756 and K092386 in liner options of 0°,0° lateralized +4mm, 20°, and 20° lateralized +4mm. The subject R3 XLPE Anteverted Liners are very similar to the R3 XLPE 20° lateralized +4mm Acetabular Liners cleared under K070756. The differences are described below. - The face of the acetabular liner has been changed by 20° to re-orient the opening face of . the liner relative to a given shell orientation when necessary - Four vents have been added to the locking detail of the subject R3 XLPE Anteverted . Liners.

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Traditional Premarket Notification are CoCr and Oxinium Femoral Head line additions in sizes 40 and 44mm and R3 XLPE Acetabular Liner line additions with inner diameters of 40 and 44mm.

Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The Reflection 3 Acetabular System is for single use only and is intended for cementless use.

Subject of this Abbreviated Premarket Notification are line additions to the R3 Acetabular System. The line additions consist of R3 Multi-Hote Shells and 36mm XLPE Acetabular Liners.

The REFLECTION 3 Acetabular System is indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, osteonecrosis, avascular necrosis, post traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseased and anomalies, and congenital dysplasia; old remote osteomyelitis with and an extended drainage-free period, in which case, the patient should be warned of an above normal danger of infection postoperatively; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The R3 Acetabular System is for single use only. The R3 Acetabular System is intended for cementless use.

The REFLECTION 3 Acetabular System consists of Acetabular shells and liners. The R3 shells are manufactured from titanium alloy. The design of the shells and liners are similar to the REFLECTION 3 Acetabular Shell, the 10MRad REFLECTION 3 Acetabular Liner cleared under K061253 and the DePuy Pinnacle Acetabular Shell cleared under K033273. The REFLECTION 3 liners are manufactured from cross-linked polyethylene. The proposed modifications will include: - · The addition of Asymmetric Porous Coating to the outside of the R3 Acetabular Shell - · The addition of the R3 MAX shell with Asymmetric Porous Coating to the outside of the shell - · The addition of the R3 MAX shell with Titanium Bead Porous Coating to the outside of the shell The Acetabular shells feature two locking grooves that correspond to locking beads on the XLPE liners, as cleared in K061253. There are also 12 indentions in the face of the shell that mate with twelve tabs of the XLPE liner to prevent rotation. The R3 Acetabular Shells and the R3 MAX shells will be offered in sizes 40mm-68mm.