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NEXUS® Hip stems 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 Titanium plasma spray and HA coatings applied to implant surfaces are intended for uncemented arthroplasty.

The MicroPort NEXUS® Hip Stem is manufactured from titanium alloy (Ti6Al4V per ASTM F620) and includes titanium plasma sprayed coating conforming to ASTM F1580 and a hydroxyapatite (HA) coating conforming to ASTM F1185. The proximal body of the hip stem has a dual titanium and HA plasma spray coating while the distal portion of the hip stem has HA coating only. The NEXUS Hip Stem features collared and collarless options and sizes 0 through 12 with standard and high offsets. The NEXUS Hip Stem is provided sterile and is a single use device. The subject NEXUS Stems are compatible with previously cleared MicroPort femoral head and shell/liner components.

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 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 modular Ceramic Femoral Head is composed of alumina matrix composite, manufactured as per ISO 6474-2. It has a 12/14 taper which is identical to the taper on MicroPort Orthopedics' range of femoral heads. The device articulates with an acetabular liner and is compatible for use across any of MicroPort Orthopedics' total hip component range.

The DYNASTY® Dual Mobility Inserts and Liners, when used with compatible acetabular shells and femoral heads, are intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients. In revision arthroplasties, all devices associated with the wear couple must be removed and replaced. 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; 5) dislocation risks; 6) treatment of non-union, femoral neck fractures of the proximal femur with head involvement which are unmanageable by other techniques Dual Mobility Inserts and Liners are single use implants intended for uncemented arthroplasty.

The Dual Mobility (DM) Inserts and Liners are designed for use with compatible DYNASTY® acetabular shells, MicroPort Orthopedics non-skirted femoral heads and PROFEMUR® femoral stems, to create a system with two articulating interfaces in the acetabular joint space of the hip. The E-CLASS® DUAL MOBILITY INSERTS are manufactured from Vitamin E cross linked polyethylene conforming to ASTM F2695 and are available with an inner diameter of 28 mm and outer diameters from 38 mm to 56 mm in 2 mm increments. The E-Class® DM Inserts are compatible with and provide a primary articulating surface for all 28 mm, non-skirted femoral heads. DM CoCr Liners are manufactured from cobalt chrome (CoCr) alloy conforming to ASTM F1537 (Type 1) and are available with inner diameters from 38 mm in 2 mm increments. The DM CoCr Liners are designed to mate with all DYNASTY® acetabular shells via a taper locking mechanism and provide the secondary articulating surface for the E-Class® DM Inserts.

The EVOLUTION® BIOFOAM® Tibial, EVOLUTION® Revision Tibial, and EVOLUTION® Revision CCK Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis; 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity; 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® BIOFOAM® Tibial System implants are for cementless use only. The EVOLUTION® Revision Tibial and EVOLUTION® Revision CCK Systems are for cemented use only.

A labeling change is taking place to include MR Conditional language and symbols to the implant components of the predicate device systems identified above. The changes only apply to the device labeling; therefore, the subject devices are identical to the predicate devices. The non-clinical testing provided establishes the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The subject devices include the following components and basic design features: - . Metal femoral components manufactured from cobalt chrome alloy - . Femoral revision accessories, including augments, manufactured from titanium alloy - . CCK tibial inserts manufactured from UHMWPE with locking screws and posts manufactured from titanium alloy - . Tibial bases manufactured from titanium alloy available in porous and non-porous versions - Tibial revision accessories, including keels, augments, stem extensions, and adapters, . manufactured from titanium alloy. - . Patellae manufactured from UHMWPE and cobalt chrome alloy

PROCOTYL® PRIME hip 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, ankyloses, protrusion 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® metal foam coating are intended only for uncemented arthroplasty.

The PROCOTYL® PRIME E-CLASS™ XLPE Liner is an additional liner option for MicroPort Orthopedics' PROCOTYL® PRIME Acetabular Cup System (K170444). The design features are summarized below: - Manufactured from E-CLASS™ vitamin E blended highly crosslinked ultra high . molecular weight polyethylene (VEXLPE) conforming to ASTM F2695-12 - Available in Standard, Lipped, or Face-Changing Lateralized Configurations . - Inner Diameter sizes 22mm to 44mm o

The ADVANCE® BIOFOAM® and EVOLUTION® BIOFOAM® tibial bases are indicated for use in knee athroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, or avascular necrosis; 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity; 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The ADVANCE® BIOFOAM® Tibial System and EVOLUTION® BIOFOAM® Tibial System implants are for cementless use only. The DYNASTY® BIOFOAM® Acetabular Shell 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, ankyloses, protrusion acetabuli, and painful hip dysplasia; 2. Inflammatory degenerative joint disease such as rheumatoid arthritis; 3. Correction of functional deformity; 4. Revision procedures where other treatments or devices have failed. The DYNASTY® BIOFOAM® Acetabular Shell is for uncemented use only.

A process change is taking place to introduce BIOFOAM® Additive Manufacturing (BIOFOAM® AM) as an alternative to the currently manufactured BIOFOAM® material used as a porous coating. BIOFOAM® AM will be used as a porous coating for MicroPort Orthopedics' tibial bases and acetabular shells with the current BIOFOAM® material as a porous coating. The BIOFOAM® AM is a porous material manufactured from the same raw material as the predicate, Commercially Pure Titanium conforming to ASTM F67, The surface treatment of BIOFOAM® AM is identical to the predicate and helps to provide initial fixation. The structure and porosity of BIOFOAM® AM is designed to encourage bone apposition.

The EVOLUTION® Revision Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

The EVOLUTION® Revision Tibial System is being introduced to supplement MicroPort Orthopedics' knee product lines to provide revision surgery options with a cemented tibial base. The design features are summarized below: - Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought) . - Available in 8 standard sizes, left and right ● - . Available in 3 plus sizes, left and right - Tibial base has holes for augment attachment screws - System includes tibial base, modular keels, block augments, stem adapters (offset & extension), stem extensions (cemented & canal-filling cementless) and stem caps (metallic and poly)

MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. ADVANCE® 913 Medial Pivot Tibial Base and Insert Components (not licensed for sale in Canada) are for use with bone cement. Porous-Coated Total Knee Replacement Components are for use without bone cement. The EVOLUTION® Total Knee System is for cemented use only.

The subject devices for this submission are all the predicate devices listed above, which consists of implant components used in knee arthroplasty. The only changes to the subject devices are updates to their labeling. 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. Testing is provided in this Traditional 510(k) that establishes the conditional safety and compatibility of the passive implants in a magnetic resonance (MR) environment. The basic design features are the following: - Metal Femoral component manufactured from cobalt chrome alloy ● - Femoral components available in porous and non porous versions - Tibial inserts manufactured from UHMWPE - Tibial bases manufactured from cobalt chrome alloy or titanium alloy ● - Tibial bases available in porous and non porous versions ● - All-poly patellae manufactured from UHMWPE - Metal portion of metal backed patellae manufactured from titanium allov .

The EVOLUTION® BIOFOAM® Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity; 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The EVOLUTION® BIOFOAM® Tibial System is for use without bone cement. The ADVANCE® BIOFOAM® Tibial System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis; 2. Inflammatory degenerative joint disease, including rheumatoid arthritis; 3. Correction of functional deformity; 4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. The ADVANCE® BIOFOAM® Tibial System is for use without bone cement and is intended for use with EVOLUTION® and ADVANCE® modular keels.

The EVOLUTION® BIOFOAM® Tibial System is a line extension of the EVOLUTION® MP Total Knee System product line. The device is an asymmetrical tibial base with a BIOFOAM® coating on the distal surface. The design features are summarized below: . Manufactured from titanium alloy conforming to ASTM F620/F136 (forged/wrought) . Available in 11 sizes, left and right Tibial base is available with and without holes for bone screws ● . System includes 3 options of modular keels consisting of a two fin bullet-tip, a four fin bullet-tip and a four fin stem-accepting keel Compatible with 510(k) cleared EVOLUTION® Tibial Inserts, ADVANCE® . Keels and ADVANTIM® Stems The keel compatibility for the ADVANCE® BIOFOAM® Tibia is being expanded to include all keels subject to this 510(k). The subject design and indications remain identical according to K063128.

The PROFEMUR® Preserve Sizes 1-3 Hip Stems are intended 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® Preserve Sizes 1-3 Hip Stems are single use components, intended for use in conjunction with associated ceramic or metal femoral heads as part of uncemented total hip arthroplasty.

The purpose of this submission is to provide additional sizing options for the predicate PROFEMUR® Preserve Hip Stems (K112080) by adding a line extension. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are modular stems manufactured from a forged titanium alloy (ASTM F620) and designed for use in uncemented total hip arthroplasty. The PROFEMUR® Preserve Sizes 1-3 Hip Stems are available in three configurations and are coated with titanium plasma spray conforming to ASTM F1580.