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Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: - **Non-inflammatory degenerative joint disease including** - osteoarthritis - traumatic arthritis, and - avascular necrosis (not applicable to Physica TT Tibial Plate); - **Inflammatory degenerative joint disease including rheumatoid arthritis;** - **Correction of functional deformity;** - **Revision procedures where other treatments or devices have failed; and** - **Treatment of fractures that are unmanageable using other techniques.** **Additional indications for Physica LMC component are:** - Moderate varus, valgus, or flexion deformities. In patients with preserved and well functioning collateral ligaments, Physica PS, PS Pro and HPS components are also indicated for: - **Absent or not-functioning posterior cruciate ligament;** - **Severe antero-posterior instability of the knee joint.** **Additional indications for Physica HPS component are:** - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. - Collagen disorders, and/or avascular necrosis of the femoral condyle. - Moderate varus, valgus, or flexion deformities. Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use. Tibial liners can be used with cemented or uncemented tibial or femoral components.

This 510(k) submission aims at introducing the Physica CR Porous Femoral components as part of the subject Physica system. The subject device components are intended to be used without cement, articulating with other components of the cleared Physica system. The Physica system (including subject Physica CR Porous Femoral components) is intended for a total knee replacement. Physica CR Porous Femoral components are designed based on the cemented Physica CR Femoral components already cleared (K151266). They are made of CoCrMo (ISO 5832-4 / ASTM F75) and are intended to replace the condyles of the distal femur. The femoral components are available in ten sizes (left and right) and are intended to replace the condyles of the distal femur. The femoral components are available in left and right versions and have an asymmetric anterior flange (to adapt left and right knees) with symmetric condyles for the articulation with the tibial liner.

The MedalOne Total Knee System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or 1) avascular necrosis; - 2) inflammatory degenerative joint disease including rheumatoid arthritis; - 3) correction of functional deformity: revision procedures where other treatments or devices have failed: and treatment of fractures 4) that are unmanageable using other techniques. The MedalOne Total Knee System is for cemented use only.

The subject device, MedalOne Total Knee System, is intended for reduction or relief of pain and/or improved knee function. The subject device is a total knee replacement system composed of four different component types: MedalOne Femoral Component, MedalOne CS Tibial Insert, MedalOne Tibial Base and SoSuperior Patella. The subject system is based on, and substantially equivalent to, the predicate EVOLUTION® MP Total Knee System in terms of size availability, geometry, nominal dimensions, manufacturing tolerances, overall device processing steps, and materials of construction. The articulation adheres to the same "Medial-Pivot" philosophy as the predicate device. The femoral components are made from Cobalt Chrome alloy conforming to ISO 5832-4 and are offered in sizes 1-8 in left and right variants. The tibial inserts are made from standard UHMWPE conforming to ISO 5834-2 and are available in sizes 1-8 in standard and "extended" versions with thickness options of 10, 12, 14, 17, 20, and 24mm. The tibial bases are made from Cobalt Chrome alloy conforming to ISO 5832-4 and are available in 8 standard sizes and 3 plus sizes to permit 1-up/1-down size interchangeability. The patellas are made from UHMWPE conforming to ISO 5834-2 and are offered in a tri-peg design in 4 sizes: 26, 29, 32, and 35mm. The system is intended to be used with bone cement for fixation. The system also includes device-specific instrumentation to facilitate implantation of the subject devices. The instrument system includes new MedalOne instrumentation and is fully compatible with the predicate Evolution instrumentation.

General Total Knee Arthroplasty (TKR) Indications: • Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. · Post-traumatic loss of knee joint configuration and function. · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Revision of previous unsuccessful knee replacement or other procedure. - Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques. The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented use. The Triathlon® Total Knee System beaded with Peri-Apatite components are intended for uncemented use only. The Triathlon® All Polyethylene tibial components are indicated for cemented use only. Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components: - · Ligamentous instability requiring implant bearing surface geometries with increased constraint. - · Absent or non-functioning posterior cruciate ligament. · Severe anteroposterior instability of the knee joint. Additional Indications for Total Stabilizer (TS) Components: · Severe instability of the knee secondary to compromised collateral ligament integrity or function. Indications for Bone Augments: · Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatic arthritis, complicated by the presence of bone loss. · Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss. Additional Indications for Cone Augments: - · Severe degeneration or trauma requiring extensive resection and replacement - · Femoral and Tibial bone voids - Metaphyseal reconstruction The Triathlon TS Cone Augment components are intended for cemented or cementless use. Triathlon Pro Posterior Stabilized Femoral Components Indications for Use: General Total Knee Arthroplasty (TKR) Indications: · Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. - · Post-traumatic loss of knee joint configuration and function. · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. · Revision of previous unsuccessful knee replacement or other procedure. · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture -management techniques. Additional Indications for Posterior Stabilized (PS) components: - · Ligamentous instability requiring implant bearing surface geometries with increased constraint. - · Absent or non-functioning posterior cruciate ligament. - · Severe anteroposterior instability of the knee joint. The Triathlon® Pro PS Femoral Components are intended for cemented use only. Triathlon Tritanium Tibial Baseplate Indications for Use: General Total Knee Arthroplasty (TKR) Indications: · Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or rheumatoid arthritis - · Post-traumatic loss of knee joint configuration and function - · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability - · Revision of previous unsuccessful knee replacement or other procedure - · Fracture of the distal femur and/or proximal tibia that cannot be standard fracture management techniques Additional General Total Knee Arthroplasty (TKR) Indications specific to the PS implant: - · Ligamentous instability requiring implant bearing surface geometries with increased constraint - Absent or non-functioning posterior cruciate ligament - · Severe anteroposterior instability of the knee joint The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use. Triathlon Low Profile Tibial Tray Indications for Use: The Triathlon Low Profile Tibial Tray is intended to be used with commercially available Triathlon® femoral components and associated patellar components, and tibial bearing inserts in primary cemented total knee arthroplasty. The indications for the Triathlon® Low Profile Tibial Tray are outlined below: Indications for Use: · Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. · Post-traumatic loss of knee joint configuration and function. · Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. Triathlon Metal Backed Patella Indications for Use: - · Noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis; - Rheumatoid arthritis; - · Correction of functional deformity; - · Revision procedures where other treatments or devices have failed; - · Post traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, - · Irreparable fracture of the knee. These products are intended to achieve fixation without the use of bone cement. Triathlon Partial Knee System Indications for Use: Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis · Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis · As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis · Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau. These components are intended for implantation with bone cement. Avon Patello-femoral Joint Prosthesis Indications for Use: The Avon Patello-femoral Joint Prosthesis is intended to be used in cemented patellofemoral arthroplasty in patients with degenerative arthritis in the distal femur and patients with a history of patellar dislocation or patella fracture, or patients with failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity, or dysfunction persists. These components are single use only and are intended for implantation with bone cement. Restoris Multi-Compartmental Knee System Indications for Use: Restoris MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include: - Medial unicondylar - Lateral unicondylar - Patellofemoral - · Medial bi-compartmental (medial unicondylar and patellofemoral) Restoris Multi Compartmental Knee is for single use only and is intended for implantation with bone cement.

All of the subject devices have been found substantially equivalent in previous 510(k)s. All the subject devices have been cleared for MR conditional labeling in previous 510(k)s. The purpose of this submission is to modify the MR conditional information in the instructions for use to update the parameters in which a patient who has the device can be safely scanned, per testing conducted accordance to updated FDA guidance. There have been no changes made to the devices requiring 510(k) clearance - only the MR conditional information in the instruction for use is being modified. An additional contraindication is being added to the components of the Triathlon Total Knee System. This contraindication regarding material sensitivity to implant materials is being added.

ATTUNE™ Total Knee System Indications for Use 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. ATTUNE™ Cementless Knee System Indications for Use The ATTUNE™ Cementless CR and PS Femoral Components are intended for cementless use within the ATTUNE™ 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, or a failed previous implant (provided that adequate bone is present). LPS TM Limb Preservation System Indications for Use The DePuy LPS System is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include: - · malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection and replacement; - · patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement; - · revision cases for a failed previous prosthesis requiring extensive resection and replacement; - · severe trauma requiring extensive resection and replacement. The LPS System is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required. The S-ROM tibial tray and the non-porous coated straight and bowed stems are intended for cemented use only. The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications. Sigma™ High Performance (HP) Partial Knee System Indications for Use The SIGMA™ High Performance Partial Knee System is indicated for single compartmental knee replacement in skeletally mature individuals with osteoarthritis, post-traumatic arthritis of the tibiofemoral surfaces or a history of gout or pseudogout. All components are intended for CEMENTED USE ONLY.

ATTUNE™ Total Knee System: 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. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design. ATTUNE™ Cementless Knee System: 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. The femoral component is a metal implant with or without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design. LPS - Limb Preservation System: The DePuy LPSTM Limb Preservation System is designed for the replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The DePuy LPS system offers a variety of component options (including, but not limited to, proximal femoral bodies, segmental components, distal femoral components, femoral stems, tibial stems, proximal tibial components, hinged tibial insert bearings, metaphyseal sleeves, and adapters). The components, which can be used in conjunction with certain components from other systems, are for treatment of patients presenting bone loss and deformity associated with bone tumors resection, trauma, infection, and difficult revision arthroplasty. A total femoral replacement is possible in those cases where no part of the femur can be salvaged. Sigma High Performance (HP) Partial Knee System: The DePuy SIGMATM High Performance Partial Knee System is a single compartmental knee prosthesis, composed of individually packaged femoral, and tibial components designed to be used in various combinations to replace the natural articular surfaces of the knee joint. The unicompartmental femoral components are Co-Cr-Mo metal implants. The metal backed tibial components are Co-Cr-Mo with polyethylene inserts. The all-polyethylene unicompartmental tibial component are manufactured from polyethylene. The unicompartmental femoral components are designed for individuals who require a higher than normal degree of flexion (up to 155°).

The Modular Rotating Hinge Knee System is intended to be implanted with bone cement for the following conditions: - · There is destruction of the joint surfaces, with or without significant bone deformity - · The cruciate and/or collateral ligaments do not stabilize the knee joint - · The ligaments are inadequate and/or the musculature is weak and/or · Revision is required of a failed prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue Indication for Use for Duracon Components (Cobalt Chrome & Titanium Stems, and Tibial Wedges) and Stryker Stem Components: Indications for use of total knee replacement prostheses include: - · noninflammatory degenerative joint disease including osteoarthritis or avascular necrosis; - rheumatoid arthritis; - · correction of functional deformity; - · revision procedures where other treatments or devices have failed; - · post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and - · irreparable fracture of the knee. Indications for US and Rest of World for Total Stabilizer Offset Adapter: Indications for use of total knee replacement prostheses include: 1) Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis; - 2) Rheumatoid arthritis; 3) Correction of functional deformity: 4) Revision procedures where other treatments or devices have failed; 5) Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy: and. 6) Irreparable fracture of the knee When the Total Knee Replacement Prosthesis is used with the components of the Modular Rotating Hinge Knee System, the indication for the Modular Rotating Hinge Knee with Offset Adapters is as follows: The Rotating Hinge Knee Systems are intended to be implanted with bone cement for the following condition(s): 1) There is destruction of the joint surfaces, with or without significant bone deformity. 2) The cruciate and/or collateral ligaments do not stabilize the knee joint. 3) The ligaments are inadequate and/or the musculature is weak and/or, 4) Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue. GMRS Pediatric Tibial Bearing Component: Replacement of the distal femur and/or proximal tibia in Oncology cases where radical resection and replacement of bone is required, and in limb salvage procedures where radical resection and replacement of the bone is required. Limb salvage procedures would include surgical intervention for severe trauma, failed previous prosthesis, and/or Oncology indications. This smaller size component is intended to be used in patients with a smaller bone structure, or in skeletally immature patients. This component is intended for use with bone cement. MRS Pediatric All Poly Tibial Component: MRS Pediatric All Polyethylene Tibial Component is intended to be used in oncology patients where radical resection of the distal femur/proximal tibia is required. Additional indications include limb salvage procedures where radical resection and replacement of the distal femur/proximal tibia is required. Limb salvage includes surgical intervention for severe trauma, failed previous knee arthroplasties, and/or oncology indications.

The Modular Rotating Hinge (MRH) Knee System is a tri-compartmental knee system that consists of a stemmed femoral component and a stemmed tibial rotation component, connected by a set of bushings and an axle. A bumper locks this assembly. This assembly provides motion through the axle/bushing combinations in the flexion/extension plane. The articulation between the cylindrical bearing surfaces on the underside of the tibial rotating component and a tibial insert provide motion in the rotation plane. The tibial insert is assembled to a tibial stemmed tray which incorporates a longitudinal bore to accept a tibial sleeve. The Modular Rotating Hinge Knee System is designed to provide varus/valgus stability throughout the range of motion, internal/external rotation about the tibial axis, constrained by the bearing surface radius on the tibial rotating component, and an extensive range of size, modularity and resection options. The implant system consists of a femoral component in five sizes, a tibial rotating component in five sizes, tibial crossover bearing components in various sizes, bumper inserts, tibial and femoral augmentation components and a tibial sleeve. The MRH Knee System is compatible with components of the Kinemax/Kinematic Knee System, Duracon Knee System, Howmedica Total Stabilizer Knee System, and the GMRS/MRS System.

RESTORIS™ Multicompartmental Knee (MCK) System is indicated for single or multi-compartmental knee replacement used in conjunction with RO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or posttraumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include: - · Medial unicondylar - · Lateral unicondylar - · Patellofemoral - · Medial bi-compartmental (medial unicondylar and patellofemoral) RESTORIS™ Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.

The purpose of this Changes Being Effected premarket notification is to add a contraindication for the Restoris Multicompartmental Knee (MCK) System. Additionally, minor modifications are being made to the contraindications for clarity. There is no change to the intended use, indications, design, technological characteristics or operational principles for the devices. The subject implant components are identical to the predicate components. The Restoris MCK system was most recently cleared in K180612, and has also been cleared previously in K172326, K150307, K090763, K082172, K082088, K082081, and K080368.

Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: - · Non-inflammatory degenerative joint disease including - o osteoarthritis - o traumatic arthritis, and - avascular necrosis (not applicable to Physica TT Tibial Plate); - Inflammatory degenerative joint disease including rheumatoid arthritis; - · Correction of functional deformity; - Revision procedures where other treatments or devices have failed; and - · Treatment of fractures that are unmanageable using other techniques. Additional indications for Physica LMC component are: - Moderate varus, valgus, or flexion deformities. In patients with preserved and well functioning collateral ligaments, PS Pro and HPS components are also indicated for: - Absent or not-functioning posterior cruciate ligament; - · Severe antero-posterior instability of the knee joint. Additional indications for Physica HPS component are: - Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. - The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. - · Collagen disorders, and/or avascular necrosis of the femoral condyle. - · Moderate varus, valgus, or flexion deformities. AMF Revision TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon. Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement. Tibial liners can be used with cemented or uncemented tibial or femoral components.

The Physica system is a total knee replacement system consisting of a Femoral component, a Tibial plate, a Tibial liner, a Tibial stem and a Patella component; the Tibial stem and the Patellar component are optional to be used as required for each individual patient and as allowed in the Instructions for Use. The Physica PS PRO Femoral component is made of CoCrMo alloy; Physica PS, PS PRO and HPS Tibial liners are made of cross-linked UHMWPE with Vitamin E. The PS PRO Femoral component is intended to be used with bone cement. The addition of the High Posterior Stabilized (HPS) LimaVit articular surface will provide the surgeon with a more constrained option in obtaining moderate varus/valgus and/or internal/external rotation constraint compared to Physica system posterior stabilized articular surfaces.

Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: - · Non-inflammatory degenerative joint disease including - o osteoarthritis - o traumatic arthritis, and - o avascular necrosis (not applicable to Physica TT Tibial Plate); - · Inflammatory degenerative joint disease including rheumatoid arthritis; - · Correction of functional deformity: - Revision procedures where other treatments or devices have failed; and - · Treatment of fractures that are unmanageable using other techniques. Additional indications for Physica LMC component are: - . Moderate varus, valgus, or flexion deformities. In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated for: - · Absent or not-functioning posterior cruciate ligament; - · Severe antero-posterior instability of the knee joint. AMF Revision TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the clinical judgment of the surgeon. Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the bone and are fixed to the femoral and tibial implants using bone cement. Tibial liners can be used with cemented or uncemented tibial or femoral components.

Physica LMC Knee System is a modular knee system which consists of Physica LMC tibial liner, made of UHMWPE or LimaVit, used in combination with a Physica CR femoral component, Physica tibial plate, cemented or uncemented versions, Physica patellar component, made of standard UHMWPE or LimaVit and Physica tibial stem, that were cleared as part of the Physica Knee System in K141934, K151266 and K201084. The Physica LMC knee system is intended to be used in patients with or without a functioning posterior cruciate ligament.

General: The LinkSymphoKnee System is intended for primary and revision total knee replacement in skeletally mature patients with the following conditions. This device is intended for cemented use only unless a cementless modular stem is indicated for use. Indications: Primary degenerative arthritis / osteoarthritis Secondary arthritis resulting from rheumatoid arthritis Fracture

The LinkSymphoKnee System is available in multiple versions with different applications, characteristics, and materials. The LinkSymphoKnee Cruciate Retaining (CR) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for crucial retaining applications made from CoCrMo, a cemented tibial component for fixed bearing (FB) applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for crucial retaining and fixed bearing applications made from cPE or X-LINKed Vit-E PE (E-Dur). The LinkSymphoKnee Posterior Stabilized (PS) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for posterior stabilized applications made from CoCrMo, a cemented tibial component for fixed bearing applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for posterior stabilized and fixed bearing applications made from cPE or X-LINKed Vit-E PE (E-Dur). Additonally, the tibial components can also be replaced by an All-Poly tibial component made from cPE. The LinkSymphoKnee Posterior Stabilized Plus (PS+) Fixed Bearing (FB) (cemented) consists of a cemented femoral component for posterior stabilized applications made from CoCrMo, a cemented tibial component for fixed bearing applications made from CoCrMo as monoblock or modular with a modular stem or a taper cap, and an articulating surface for posterior stabilized plus and fixed bearing applications that provides more stability than the standard PS. The articulating surface PS+ provides a constraint from 0 to 3 degrees of varus/valgus and from 0 to 3 degrees of internal/external rotation and is made from cPE or X-LINKed Vit-E PE (E-Dur). The LinkSymphoKnee Condylar Constrained (CCK) Fixed Bearing (FB) consists of a cemented femoral component for condylar constrained applications made from CoCrMo with a cemented modular stem made from CoCrMo or with a cementless modular stem made from TiAl6V4 (Tilastan), a cemented modular tibial component for fixed bearing applications made from CoCrMo with a cemented modular stem (CoCrMo with or without LINK PorEx (TiNbN) modification) or with a cementless modular stem made from TiAl6V4 (Tilastan), and an articulating surface for condylar constrained (CCK) and fixed bearing (FB) applications made from cPE or X-LINKed Vit-E PE (E-Dur). The femoral components can be used with distal, posterior, and L-shaped femoral augments made from TiAl6V4 (Tilastan). The modular tibial components can be used with tibial augments made from TiAl6V4 (Tilastan). The femoral and tibial components are also available in LINK PorEx (TiNbN) coated version. Additionally a 3-peg patella can be used with the LinkSymphoKnee System. It is made from cPE or X-LINKed Vit-E PE (E-Dur). The LinkSymphoKnee System is compatible with previously cleared Tibial and Femoral Cones of Waldemar Link GmbH & Co. KG (K200113 and K201364).

Physica system is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: - · Non-inflammatory degenerative joint disease including - o osteoarthritis - traumatic arthritis, and o - avascular necrosis (not applicable to Physica TT Tibial Plate); o - · Inflammatory degenerative joint disease including rheumatoid arthritis; - · Correction of functional deformity; - Revision procedures where other treatments or devices have failed; and - · Treatment of fractures that are unmanageable using other techniques. Additional indications for Physica LMC component are: - . Moderate varus, valgus, or flexion deformities. In patients with preserved and well functioning collateral ligaments, Physica PS components are also indicated for: - · Absent or not-functioning posterior cruciate ligament; - · Severe antero-posterior instability of the knee joint. AMF Revision TT Cones are intended for use in skeletally mature patients with bone defect or poor bone quality (osteoporotic bone) or in case of sclerotic bone that requires supplemental metaphyseal fixation in the surgeon. Femoral, tibial and patellar components of the Physica system are intended for cemented use, with the exception of Physica Porous Femoral components and Physica TT Tibial Plates that are intended for uncemented use, and tibial and femoral cones that are intended for uncemented fixation to the fixed to the femoral and tibial implants using bone cement. Tibial liners can be used with cemented or uncemented tibial or femoral components.

The Physica system is a total knee replacement system consisting of a Femoral component, a Tibial plate, a Tibial liner, a Tibial stem and a Patella component; the Tibial stem and the Patella component are optional to be used as required for each individual patient and as allowed in the Instructions for Use. The Physica Porous Femoral components are made of CoCrMo alloy and the internal surface is PoroTi coated; they are intended to be used without bone cement; the components to be used in combination with (Tibial plate, TT Tibial plate, Tibial liner, Tibial stem, Patella) were previously cleared (K141934, K152008, K190911, K201084).