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The DePuy Attune Total Knee System is intended for use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, or a failed previous implant.

A Total Knee Prosthesis is composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. Femoral Components The ATTUNE CR and PS Femoral Components are a metal femoral knee component intended for cemented use. The Femoral Component may be used with the native patella or a resurfaced patella. The congruency is variable and optimized throughout the range of motion. Fixed Bearing (FB) Tibial Base The ATTUNE FB Tibial Base is designed to utilize a central universal locking mechanism intended for cemented use. The tibial base incorporates a stem and keel to provide additional stability and recessed cement pockets for enhanced cement fixation. The tibial base fixation surface is textured. Fixed Bearing (FB) Tibial Insert The ATTUNE CR and PS FB Tibial Insert is a polyethylene component. The FB Tibial Inserts are secured to the metal FB Tibial Base. Patella Components The ATTUNE Medialized Dome Patella and Medialized Anatomic Patella is a polyethylene component. The patellar components are cemented to the native patella and articulate with the trochlear groove and condyles of the Femoral Component. The subject Attune medialized dome and medialized anatomic patellae are available in sizes 29, 32, 35, 38, and 41mm. The fixation surface incorporates 3 pegs to provide stability and recessed cement pockets for enhanced cement fixation. The patella components are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The articular surface is offset medially proportional to the size of the component.

The DePuy Attune Total Knee System is intended for cemented use as a total knee replacement system. Candidates for total knee replacement include patients with and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The subject device is a polyethylene tibial inserts and patella component made from AOX Polyethylene that mates with existing cemented and noncemented femoral and tibial base components

The A200 Knee System is intended for use in total knee arthroplasty for the following indications: 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. 2. Correction of varus, valgus, or posttraumatic deformity. 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is intended for cemented use only.

The A200 Knee System consists of the following components: Femoral Components - nine (9) sizes in a cruciate-retained (CR) design, each for left and right sides, manufactured from Co-Cr-Mo allov: Tibial Tray Components - nine (9) sizes, each for the left and right sides, and each in two stem designs, a conical design manufactured from Co-Cr-Mo alloy, and a keeled design manufactured from Ti 6Al 4V alloy: Tibial Insert Components - three (3) footprint sizes, each for the left and right sides, with articulating thicknesses ranging from 10 mm to 20 mm, all in CR designs, in standard and deep dish configurations, manufactured from highly crosslinked ultra-high molecular weight polyethylene with and without vitamin E: Patellar Components five (5) sizes, in dome design, manufactured from highly crosslinked ultra-high molecular weight polvethylene with and without vitamin E: and A200 Knee Instrumentation including instruments for use with the system components, trial implant components, and general instruments. The A200 Knee System implants are manufactured from Co-Cr-Mo alloy conforming to ASTM F75, Ti-6A1-4V alloy conforming to ASTM F136, and ultra-high molecular weight polyethylene conforming to ASTM F648 and ASTM F2695. All UHMWPE is crosslinked by gamma irradiation. The metallic implant components (femoral components and tibial tray components) are sterilized by Co6 gamma irradiation, and all UHMWPE components are sterilized by ethylene oxide.

The Movation Knee System is Indicated For: 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. This system is to be used for cemented applications.

The Movation Highly Cross Linked Vitamin E Tibial Inserts are manufactured from HXL VE (75KgY) ultra high molecular weight polyethylene (UHMWPE). The tibial inserts are available in 11 sizes (1,2,3,4,5,6,7,8,10,12, and 14) and 6 thicknesses (9mm -21mm) and are provided neutral in orientation. The tibial insert is identical in design to the compression molded UHMWPE Movation tibial insert cleared via K100900. The tibial insert is identical in materials to the Highly Cross-Linked Vitamin E UHMWPE Tibial Insert cleared via K091956.

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. This system is to be used for cemented applications.

This submission is to request clearance for a line extension to the current patella product line to include a highly cross linked polyethylene patella infused with pharmaceutical grade alphatocopheral.

The DePuy Attune™ Knee System is intended for cemented use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The Attune™ posterior stabilized (PS) femoral components have an asymmetric trochlear groove and are available in sizes 1-10 in right and left options. Sizes 3-6 are available in standard and narrow options. The fixation surface is textured. It incorporates two lugs (pegs) to provide additional stability and recessed cement pockets for enhanced cement fixation. The Attune femoral components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The Attune PS fixed bearing tibial insert is designed with a topography that, in the sagittal view, consists of multiple radii. The sagittal anterior radii are relatively conforming to the femoral component to aid in anterior constraint while the posterior radius is less conforming to allow rollback. The Attune PS fixed bearing tibial inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, 18, 20, and 22mm. The inserts are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The Attune PS femoral components and PS fixed bearing inserts are compatible with the Attune FB tibial bases (K101433) and patellae (K103756). The Attune PS Total Knee is designed to accommodate knee flexion to 145 degrees in those patients able to attain a high degree of knee flexion.

The DePuy Attune™ Total Knee System is intended for cemented use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/ or severely disabled joint resulting from osteoarthritis, posttraumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The Attune medialized dome and medialized anatomic patellae are available in sizes 29, 32, 35, 38, and 41mm. The fixation surface incorporates 3 pegs to provide stability and recessed cement pockets for enhanced cement fixation. The patella components are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The articular surface is offset medially proportional to the size of the component. The Attune CR Knee System is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion.

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; - Treatment of fractures that are unmanageable using other techniques . This device may also be indicated in the salvage of previously failed surgical attempts. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.

Subject of this Traditional 510(k) Premarket Notification is a request for labeling claims for the DJO Surgical 3DKnee HXL VE Tibial Insert. The in vitro wear claim will be made for the use of the 3DKnee femoral component coupled with a 3DKnee HXL VE Insert. It is important to note that there are no new total knee components being introduced as a result of this Traditional 510(k) premarket notification.

The DePuy Attune™ Knee System is intended for cemented use as a total knee replacement system. Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

The Attune™ femoral components are available in a cruciate retaining (CR) version. The CR femoral components have an asymmetric trochlear groove and are available in sizes 1-10 in right and left options. Sizes 3-6 are available in standard and narrow options. The fixation surface is textured. It incorporates two lugs (pegs) to provide additional stability and recessed cement pockets for enhanced cement fixation. The Attune Femoral Components are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The Attune fixed bearing CR tibial insert is designed with a topography that, in the sagittal view, consists of multiple radii. The sagittal anterior radii are tight to aid in anterior constraint while the posterior radius is larger to allow rollback. The Attune design allows for the retained posterior cruciate ligament and/or balanced posterior capsule to assist in appropriate rollback of the femur. The design offers minimal but appropriate constraint in the posterior direction for maximal rollback and full range of motion. The Attune fixed bearing CR tibial inserts are available in sizes 1-10 and in thicknesses of 5, 6, 7, 8, 10, 12, 14, 16, and 18mm. The inserts are manufactured from AOX ultra high molecular weight polvethvlene conforming to ASTM F648. The Attune tibial bases are available in sizes 1-10. The Attune tibial base fixation surface is textured. It incorporates a stem and keel to provide additional stability and recessed cement pockets for enhanced cement fixation. The Attune tibial base utilizes a central universal locking mechanism to capture the tibial insert. The Attune tibial bases are manufactured from cast Co-Cr-Mo alloy conforming to ASTM F75. The Attune patellae are available in sizes 29, 32, 35, 38, and 41mm. The fixation surface incorporates 3 pegs to provide stability and recessed cement pockets for enhanced cement fixation. The patella components are manufactured from AOX ultra high molecular weight polyethylene conforming to ASTM F648. The Attune Knee System is designed to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion. Total knee replacement is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The Attune Knee System is intended to accommodate knee flexion to 150 degrees in those patients able to attain a high degree of knee flexion.

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. This device is intended to be used with the 3DKnee System for cemented or uncemented applications.

The Highly Cross-Linked Vitamin E UHMWPE (HXL VE) Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) powder that is blended with pure liquid pharmaceutical grade alpha-tocopheral, compression molded and then highly cross-linked. The tibial inserts are available in 9 sizes (2- 12) and 5 thicknesses (9-19) and are provided in right and left orientations. The HXL VE Tibial Insert design is identical to the 3DKnee Tibial Insert cleared via K020114. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle. The baseplate attachment mechanism is the same as the previously cleared 3DKnee System inserts.