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AltiVate Reverse® Shoulder System, Reverse® Shoulder Prosthesis (RSP®), SMR Shoulder System, PRIMA Humeral System, and PRIMA Glenoid System are intended for various forms of partial or total, primary or revision shoulder joint replacement. Specific indications depend on the system and configuration (modular, monoblock, anatomic, reverse), addressing conditions such as: - Grossly rotator cuff deficient shoulder joint with severe arthropathy - Previously failed joint replacement with a grossly rotator cuff deficient shoulder joint - Functional deltoid muscle is necessary to use the device - Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder (including humeral head fracture or displaced 3- or 4-part fractures of proximal humerus) - Bone defect in proximal humerus - Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid - Inflammatory arthritis including rheumatoid arthritis - Correction of functional deformity - Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods - Revision of a failed primary implant (if sufficient bone stock remains) - Cuff tear arthropathy (CTA Heads only) - Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid Glenoid only) - Massive irreparable rotator cuff tear The patient's joint must be anatomically and structurally suited to receive the selected implant(s). Some components are intended for cemented and/or cementless application, often with the addition of screws for fixation. Revision surgery can include conversion from anatomic to reverse arthroplasty if the stem is stable, well positioned, and tissue integrated.

This 510(k) submission proposes updated labeling to reflect additional compatibility between previously cleared shoulder systems from Encore Medical, L.P. (AltiVate Reverse® Shoulder System) and LimaCorporate S.p.A. (SMR and PRIMA Shoulder Systems). The update allows for cross-system use of humeral and glenoid components for reverse total shoulder arthroplasty, where compatible sizes exist. There are no changes to the design, materials, function, or intended use of the devices, and no new implants or instruments are introduced. The proposed configurations include using an AltiVate Reverse® humeral stem and insert with SMR or PRIMA glenoid components, and vice versa.

Joint replacement is indicated for patients suffering from disability due to: - · Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural head; - Rheumatoid arthritis; - · Correction of functional deformity; - Femoral fracture This device may also be indicated in the salvage of previously failed surgical attempts. The EMPOWR Dual Mobility™ system has the additional indication of joint replacement due to dislocation risks. The constrained acetabular component is indicated for primary or revision at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for who all other options to constrained acetabular components have been considered.

The ceramys™ femoral head system represents the latest generation of prosthetic femoral heads used in hip arthroplasty. The ceramys™ femoral head system is applicable for use in total hip arthroplasty and the prosthetic replacement of femoral neck fractures. It offers a femoral head design with a reproducible surgical technique carefully developed to enable consistent and accurate implantation. The ceramys™ femoral head system is composed of ceramys™ femoral heads, ceramys™ choice sleeved femoral heads, and ceramys™ choice sleeves. The ceramys™ femoral head system consists of alumina toughened zirconia ceramic heads and titanium adapter sleeves that connect to femoral stems using a 12/14 taper. The ceramys™ choice femoral heads and sleeves can be used with a well fixed stem in revision hip arthroplasty. The femoral head spherical diameter will be offered as 28, 32, 36, 40, and 44 mm and the femoral head center is offered in 4 increments ranging from -4 to +8 mm.

The AltiVate Reverse® Shoulder Prosthesis is indicated as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to: Severe arthropathy with a grossly deficient rotator cuff; Previously failed joint replacement with a grossly deficient rotator cuff; Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection; Bone defect in proximal humerus; Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid; Inflammatory arthritis including rheumatoid arthritis; Correction of functional deformity. The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures. All RSP® Monoblock and AltiVate Reverse® humeral stems are intended for cemented or cementless use.

The AltiVate Reverse® Glenoid is a line extension to the existing RSP Glenoid System consisting of additional size offerings, modularity, and augment/revision offerings for varying glenoid morphologies for use in reverse Total Shoulder Arthroplasty (TSA) applications. The new implants consist of modular neutral and augmented baseplates, Torx peripheral screws, porous coated pegs, and additional offsets of glenospheres. All of the subject device implants are manufactured from Ti-6Al-4V except the glenospheres, which are manufactured from CoCrMo. New device specific accessories/instruments have been developed and are intended to facilitate proper implantation of the glenoid shoulder system.

Total joint replacement is indicated for patients suffering from disability due to: -degenerative, post-traumatic or rheumatoid arthritis; -avascular necrosis of the femoral condyle; -post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; -moderate valgus, varus or flexion deformities; This device may also be indicated in the salvage of previously failed surgical attempts where bone loss may require the use of augments, sleeves cones or extensions. The EMPOWR Revision Knee™ Symmetric Cones are indicated for the following conditions: EMPOWR™ Revision Knee™ Symmetric Cones are indicated for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental fixation in the clinical judgment of the surgeon. EMPOWR™ Revision Knee™ Symmetric Cones are indicated for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement.

Envois is adding a non-mating modular component accessory to the EMPOWR™ Knee product line and is compatible with the EMPOWR Revision Knee™ Femur (K213793), the EMPOWR PS Knee® Femur (K160342), the EMPOWR ™ Universal Tibial Baseplate (K173723), and the EMPOWR™ Knee Cemented Stems and Extender Accessories (K173723, K213793, and K230441). The EMPOWR Revision Knee™ Symmetric Cone implants (also known as Cones) are an optional accessory in primary or revision Total Knee Arthroplasty. The Cones are sterile, single-use device that are compatible for use with the EMPOWR Revision Knee™ components. The EMPOWR™ Cones are composed of Ti6Al4V alloy per ASTM F1472 and contain a modified surface composed of commercially pure titanium per ASTM F67. This modified surface (i.e. porous coating) is exactly the same as applied to existing FMP™ Porous Coated Acetabular Shells (K072888). The EMPOWR Revision Knee™ Symmetric Cones are intended to the mating femoral and/or tibial component using bone cement. The cones are intended for fixation as an assembled construct in the distal femur and/or proximal tibia, without bone cement.

The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to: · Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis - · Rheumatoid and other inflammatory arthritis - · Correction of functional deformity, including fracture malunion - · Humeral head fracture - · Revision of other devices if sufficient bone stock remains The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty. Humeral components with a porous coated surface are indicated for either cemented or uncemented applications. Glenoid components are indicated for cemented use only.

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers (Full-Wedge), as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.

Joint replacement is indicated for patients suffering from disability due to: - · degenerative, post-traumatic or rheumatoid arthritis; - · avascular necrosis of the femoral condyle; - · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; - · moderate valgus, varus or flexion deformities; - · treatment of fractures that are unmanageable using other techniques. This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, and EMPOWR POROUS Tibia which are intended for cementless applications. While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients. The EMPOWR Revision VVC+, e+ Tibial Insert should be considered for use in total knee arthroplasty for patients under the following indications: · absence or loss of both cruciate ligaments - · moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgement of the surgeon - · bone loss that requires supplemental fixation in the clinical judgement of the surgeon

The EMPOWR Revision VVC+ (Varus / Valgus Constrained) e+ Tibial Insert Implant is a line extension that offers an increased level of femoral / tibial constraint over the EMPOWR VVC Tibial Insert. This tibial insert implant provides additional internal / external and varus / valgus rotational stability. The sizing architecture for the insert includes 14 sizes (2-11, 4BU, 5BU, 6BD, 7BD) and thicknesses of 10mm, 12mm, 14mm, 16mm, 19mm, 22mm and 25mm with post medial/lateral width of 0.5520 inches for sizes 2-5 and 0.7080 inches for sizes 6 - 11. Along with the post width, the articulating geometry of the proximal side of the tibial insert accommodates an additional amount of internal / external (I/E), varus / valgus (V/V) constraint, and tibial post / femoral cam jump height when interfacing with the EMPOWR Revision Femoral implant. The material (highly crosslinked 75kGy UHMWPE with vitamin E per ASTM F2695/F2565) and distal locking mechanism geometry with the mating tibial baseplate are identical to the predicate. All tibial insert thickness options are configured to interface with a reinforcement pin accessory made of Wrought CoCr per ASTM F1537. This accessory is configured with a taper interface on the distal end to mate with the EMPOWR UNIVERSAL TIBIAL BASEPLATE, has a diameter and length configured to reinforce the post and thickness for the EMPOWR Revision VVC+ e+ tibial insert, and contains barbs to prevent the pin from backout when fully seated within the post of the EMPOWR Revision VVC+, e+ tibial insert.

Joint replacement is indicated for patients suffering from disability due to: - · degenerative, post-traumatic or rheumatoid arthritis; - · avascular necrosis of the femoral condyle; - · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy; - · moderate valgus, varus or flexion deformities; - · treatment of fractures that are unmanageable using other techniques. This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR 3DKNEE™ POROUS Femur, 3DKNEE™ Porous Coated Tibia, and EMPOWR POROUS Tibia which are intended for cementless applications. While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Stem Extender, 50mm implant is a modular accessory of the EMPOWR Revision Knee (K213793). When coupled with the EMPOWR Revision Knee, the Stem Extender is intended to be fixed to the bone by cement. The extender is connected to the mating implant, Revision Femur, by 7/16-20 UNF-2A male threaded connection on the implant, and 7/16-20 UNF-2B female threaded connection on the other side that is used to "extend" the length of cemented stem accessories (K173723) in an identical way as the EMPOWR Stem Extender, 25mm (K213793). The Stem Extender is also compatible with the EMPOWR Universal Tibial Baseplate (K173723) and will be offered for use as an accessory with the baseplate. The EMPOWR Stem 50mm Extender comes in a single diameter of 15mm and is offered a length of 50mm (Refer to Figure 1). The EMPOWR Stem Extender, 50mm is made of wrought CoCr alloy per ASTM F1537, which is identical to the material used in the 25mm extender included in the EMPOWR Revision Knee (K213793).

The AltiVate® Anatomic Shoulder System is indicated as an anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to: • Non-inflammatory degenerative joint disease including osteoarthritis, avascular necrosis of the natural humeral head and/or glenoid, and post traumatic arthritis · Rheumatoid and other inflammatory arthritis - · Correction of functional deformity, including fracture malunion - · Humeral head fracture - · Revision of other devices if sufficient bone stock remains The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for a total shoulder arthroplasty. Humeral components with a porous coated surface are indicated for either cemented applications. Glenoid components are indicated for cemented use only.

This application is to include the AltiVate® Anatomic Shoulder AG e+™ with Markers, as a component of the AltiVate® Anatomic Shoulder System. The AltiVate® Anatomic Shoulder AG e+™ with Markers are manufactured from ultra-high molecular weight polyethylene with vitamin E. The articulating surface has a radius of curvature greater than the compatible humeral heads to allow translation in the superior/inferior and anterior/posterior directions. The back surface(s) of the component is spherical in geometry and has four pegs for fixation in the glenoid. The central peg has three annular barbs and the peripheral pegs have machined fixation features, referred to as Tri-lobes, to provide immediate fixation to the patient's glenoid when inserted. Radiographic markers are found in all three peripheral pegs.