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When a mechanical alignment approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or 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.
• 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.

When a Personalized Alignment™ approach is utilized, this device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Moderate valgus, varus, or flexion deformities.

The Personalized Alignment (PA) surgical technique may only be used with Persona cemented and uncemented CR femoral components, Persona CR, Ultra Congruent (UC), and Medial Congruent (MC) articular surface components, the Persona Cemented Stemmed tibial components without a stem extension, and the Persona OsseoTi Keel Tibia and Cemented Keel Tibia.

Porous coated components may be used cemented or uncemented (biological fixation), except for the Persona OsseoTi Keel Tibia which is for uncemented use only. All other femoral, tibial baseplate and all-polyethylene (UHMWPE and VEHXPE) patella components are indicated for cemented use only.

The purpose of this submission is to add a new Porous Plasma Spray (PPS) Coating Supplier for the Persona PPS Femurs of the Persona Personalized Knee System. The addition of this new supplier does not change the intended use, design, or fundamental scientific technology of the device.

The Persona Personalized Knee System is a semi constrained modular knee prosthesis designed to resurface the articulating surface of the femoral, tibial, and patellar bones. The femoral components articulate against an articular surface of the tibial component, as well as, a patellar component, as part of a total knee system. The femoral components come in a variety of sizes to match the needs of a patient's anatomy when performing total knee arthroplasty. These components are provided sterile and single use.

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The GMK® knee prosthesis is designed for cemented application in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

The GMK 3D Metal® Tibial Baseplate is indicated for cementless or cemented application if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
• Collagen disorders, and avascular necrosis of the femoral condyle
• Post traumatic loss of joint configuration
• Primary implantation failure

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement. The screwed tibial augments are for screwed fixation to the tibial baseplate. In case a semi-constrained liner is used, an extension stem must be implanted both on the tibial and on the femoral components. In case a GMK Revision or GMK Sphere Revision tibial tray is used, an extension stem must be implanted.

It is not possible to implant tibial wedges and extension stems with the GMK 3D Metal® Tibial Baseplate.

Limitations for use for GMK SPHERE/GMK SPHERIKA used with kinematic alignment

GMK® Sphere and GMK® SpheriKA can be implanted in kinematic alignment. In this case, this knee replacement system is indicated for:

• Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis
• Collagen disorders, and/or avascular necrosis of the femoral condyle
• Moderate valgus, varus, or flexion deformities

The subject devices are sterile, single use, individually packaged implants designed for cementless or cemented use in Total Knee Arthroplasty procedures.

The GMK 3D Metal Tibial Tray Extension is available in eleven sizes plus two bridge versions with right and left configuration.

Analogously to the predicate devices, the subject devices are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder (Ti-6Al-4V) according to ASTM F2924-14.

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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 stabilized by standard fracture-management techniques.
• Ligamentous instability requiring implant bearing surface geometries with increased constraint.
• Absent or non-functioning posterior cruciate ligament.

The subject device is intended for primary or revision total knee arthroplasty.

The subject device is a sterile, single use device that is intended for use in primary or revision total knee arthroplasty with previously cleared Triathlon® femoral and tibial baseplate components. The subject device adds to the Triathlon® Total Knee System a tibial bearing insert option with an asymmetric articulating surface which is designed to increase medial conformity with the compatible femoral components. The design is intended to provide increased sagittal stability and allow for more natural rotational kinematics. This tibial bearing insert also introduces a material change to the locking wire subcomponent located on the anterior portion of the distal baseplate mating profile. The locking wire component is intended to assemble the insert with a compatible tibial baseplate. The locking wire provided with the Triathlon® X3® Medial Stabilized Tibial Bearing Insert is made from titanium alloy (Ti-6Al-4V).

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Materialise TKA Guide System consists of hardware (Materialise TKA Guides and Models) and software (SurgiCase Knee Planner) components.

Hardware

• Pin Placement Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting.

The Materialise TKA Guides must be used in conjunction with the Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Zimmer Persona® OsseoTi® Keel Tibia, Zimmer Persona® Cemented Keel Tibia, Zimmer Persona® PPS® Femur, Vanguard® Complete Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Guides are intended for single use only.

• Cut-Through Guides
The Materialise TKA Guides are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components and in guiding the marking of bone before cutting and cutting of the bone.

The Materialise TKA Guides must be used in conjunction with the Vanguard® Complete Knee System, prostheses families only.

The Materialise TKA Guides are intended for single use only.

• Models
The Materialise TKA Models are intended to be used as a surgical instrument to assist in the intra‐operative positioning of Total Knee Replacement components.

The Materialise TKA Models must be used in conjunction with Zimmer NexGen® CR-Flex fixed bearing, Zimmer NexGen® CR fixed bearing, Zimmer NexGen® LPS-Flex fixed bearing, Zimmer NexGen® LPS fixed bearing, Zimmer Gender Solutions® Natural-Knee® fixed bearing, Zimmer Persona® CR fixed bearing, Zimmer Persona® PS fixed bearing, Zimmer Persona® OsseoTi® Keel Tibia, Zimmer Persona® Cemented Keel Tibia, Zimmer Persona® PPS® Femur, Vanguard® Complete Knee System, Lima Physica PS System Knee System, Lima Physica CR Knee System, Lima Physica KR Knee System, Omni Apex CR, Omni Apex PS, Ortho Development BKS CR, Ortho Development BKS PS, Ortho Development BKS TriMax CR and Ortho Development BKS TriMax PS prostheses families only.

The Materialise TKA Models are intended for single use only.

Software
The SurgiCase Knee Planner is intended to be used as a pre-surgical planner for knee orthopedic surgery. The software is used to pre-operatively plan the positioning of knee components. The SurgiCase Knee Planner allows the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data. The software leads to the generation of a surgery report along with a pre-surgical plan data file which is used as input data to design the Materialise TKA Guides and Models.

The Materialise TKA Guide System is a medical device designed to be used to implant total knee prosthesis components during a total knee arthroplasty surgical procedure. This can be done by generating a presurgical knee plan and by manufacturing a patient-specific knee guide and models to transfer the knee plan to surgery.

The subject device is a system that consists of the following two functional components:
• A software component branded as SurgiCase Knee Planner. This software is a planning tool used to generate a personalized pre-surgical TKA plan according to either a mechanical or a restricted kinematic alignment philosophy based on patient anatomy. This initial plan can then be further edited by the surgeon.
• Hardware components branded as Materialise TKA Guides and Models: which are patient-specific guides and models that are based on a pre-surgical plan. This pre-surgical plan is generated using the software component. Materialise TKA Guides and Models is an instrument set containing a femur and/or tibia guide(s) and bone models (optional). Both femoral and tibial guides are designed and manufactured to fit the anatomy of a specific patient. If the surgeon requests it, a bone model of the femur and/or tibia are delivered with the Materialise TKA Guides. The Materialise TKA Guides and Models assist in the intra-operative positioning of total knee replacement components. The guides assist in guiding the marking of bone before cutting and cutting of the bone. The models serve as a visual reference for the surgeon in the operating room. The Materialise TKA Guides and Models must only be used within the intended use of the compatible components (510(k) cleared, legally marketed prosthesis).

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The patient should be skeletally mature to receive a knee replacement. Patients should have adequate bone stock and size to support and accept the prosthesis.

The patient's needs for knee replacement should be due to one or more of the following conditions:

• Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis
• Inflammatory degenerative joint disease including rheumatoid arthritis
• Functional deformity such as varus, valgus or flexion deformities
• Revision procedures where other treatments or device have failed
• Fractures that are unmanageable using other techniques

Signature Orthopaedics' World Knee/Active-V Knee replacement components may be intended for cemented or cementless use.

Active-V Total Knee System
The Active-V Total Knee is a modular total knee system consisting of a femoral component, a meniscal insert, a patella, tibial baseplate with a fin keel and an external tibial augment. The femoral and tibial components are intended for cemented and cementless use. The tibial insert bearing components are available in cruciate retaining (CR) and ultracongruent (UC) variants while the femoral components are available in posterior stabilizing (PS) and CR variants. All components are intended for single use only.

The femoral component is an anatomically accurate designed prosthesis manufactured from cast cobalt chrome (CoCrMo) alloy. The tibial component is a modular symmetrical tray design, manufactured from Ti6Al4V Alloy. Cementless femoral components with plasma sprayed commercially pure titanium and hydroxyapatite coating with the option of titanium nitride coating are included. Tibial components with the same coating specifications as the femoral components are available. The tibial external augment is manufactured from the same Ti6Al4V alloy. The meniscal insert is available in CR and Medialconstrained (MC) variant surfaces, and is manufactured from Vitamin-E stabilized UHMWPE (HXLPE). The patella is a spherical, 3-peg patella design manufactured from Vitamin-E stabilized UHMWPE. Components are available for cemented or cementless use.

World Total Knee System - Line Extension
The World Knee line extension presented in this 510(k) is addition of the following components:

• Cementless femoral components with new coating specifications (plasma sprayed commercially pure titanium and hydroxyapatite coating with the option of titanium nitride coating)
• Tibial components with the modified coating specifications (same as the femoral components) and tibial tray to fin keel modular design
• Constrained condylar knee (CCK) variant of the all poly tibia component and meniscal insert, and medialconstrained (MC) variant of the meniscal insert
• Tibial external augment

The femoral component is an anatomically accurate designed prosthesis manufactured from cast cobalt chrome (CoCrMo) alloy. The tibial component is a modular symmetrical tray design, manufactured from Ti6Al4V Alloy. The tibial external augment is manufactured from the same Ti6Al4V alloy. The meniscal inserts and all poly tibia are manufactured from conventional Ultrahigh Molecular Weight Polyethylene (UHMWPE) and Vitamin E Stabilized and 100 kGy Crosslinked UHMWPE (Vit-E HXLPE). Components are available for cemented or cementless use.

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When a mechanical alignment approach is utilized, these devices are 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.

These devices may also be indicated in the salvage of previously failed surgical attempts.

When the EMPOWR® Dynamic Natural Alignment (DNA) approach is utilized, these devices are indicated for patients with disability due to:

• degenerative, post-traumatic or rheumatoid arthritis;
• avascular necrosis of the femoral condyle;
• moderate valgus, varus or flexion deformities.

All EMPOWR devices except for the EMPOWR Revision Knee™, EMPOWR PS Knee™, and EMPOWR Partial Knee™ may be implanted using the EMPOWR® Dynamic Natural Alignment (DNA) surgical technique.

All devices are intended for cemented applications except for the EMPOWR Porous® Knee Femur, EMPOWR Porous® Knee Tibia, and Porous Patella 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.

Enovis™ knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use. While total 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 purpose of this submission is to obtain clearance for the EMPOWR® Dynamic Natural Alignment (DNA) surgical technique. The proposed technique is a kinematic alignment (KA) strategy, providing an alternative alignment approach to the current mechanical alignment (MA) strategy. The purpose of the KA technique is to restore normal knee function by preserving the patient's native joint line. The technique may be used to implant all EMPOWR devices except for the EMPOWR Revision Knee™ and the EMPOWR PS Knee™. This is a labeling change only. No design changes are being introduced to the implant systems.

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Balanced Knee® System TriMax® Porous Femoral Components are intended for single use uncemented or cemented total knee arthroplasty with the following indications:

1. Loss of joint configuration and joint function.
2. Osteoarthritis of the knee joint.
3. Rheumatoid arthritis of the knee joint.
4. Post-traumatic arthritis of the knee joint.
5. Valgus, varus, or flexion deformities of the knee joint.
6. Revision procedures where other treatments or devices have failed.

Balanced Knee® System TriMax® Porous Femoral Components are intended for use as part of total knee arthroplasty (TKA) procedures. Total knee arthroplasty is a procedure where worn, diseased, or damaged surfaces of the knee joint are removed and replaced with artificial surfaces.

The components are prescription products consisting of single use devices for implanting into patients in an operating room by a qualified surgeon.

Balanced Knee® System TriMax® Porous Femoral Components are a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy femoral component with Co-Cr-Mo sintered porous coating.

The device will have two configurations:

• Cruciate Retaining (CR) Femoral – (Substantially Equivalent to K152169)
• Posterior Stabilized (PS) Femoral – (Substantially Equivalent to K123457)

They have the same materials of constructions and the same articular geometry as the legally marketed TriMax cemented femoral components. The new feature is the addition of the CoCr porous coating on the bone contacting surfaces that is substantially equivalent to the reference device: Maxx Orthopedics Freedom Porous Femoral Component (K150680).

Balanced Knee® System TriMax® Porous Femoral Components are manufactured from cast Co-Cr-Mo per ASTM F75.

The subject device has a variety of sizes to accommodate variations in patient anatomies: left and right orientations, medial-lateral width (56 – 79.5mm), anterior-posterior width (50 – 74mm), and CR & PS variations.

Balanced Knee® System TriMax® Porous Femoral Components are compatible with BKS® High Flex PS Tibial Inserts (K123457, K131337), BKS® High Flex Patellar Button (K131337), BKS® TriMax® CR and US Tibial Inserts (K152169), and BKS® TriMax® PS Plus Tibial Inserts (K233093).

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• 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.
• Revision of previous unsuccessful knee replacement or other procedure.

Triathlon® Hinge Knee System is intended to be implanted with bone cement for the following condition(s):
• 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 prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with MRH femur and/or MRH tibial baseplate replacement indicated in revision of an existing prosthesis:
• Revision is required of a failed prosthesis where there has been gross instability, with or without bone loss or inadequate soft tissue.

When used with compatible GMRS components:
• Where segmental resection and/or replacement of femur and/or proximal tibia is required.

• 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 stabilized by standard fracture management techniques.

• 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 stabilized by standard fracture management techniques.

The Triathlon Tritanium Tibial Baseplate and Tritanium Metal-Backed Patella components are indicated for both uncemented and cemented use.

The devices covered by this Traditional 510(k) Premarket Notification are Stryker UHMWPE devices (including knee patella devices and hinged knee bumper) that are packaged in a N2Vac environment. The packaging for these devices consists of an impermeable foil pouch in a Polyethylene Terephthalate Glycol (PETG) blister sealed with a Tyvek lid. All subject devices are commercially available and have been found to be substantially equivalent in previous 510(k)s.

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ATTUNE™ Total Knee 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.

ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors
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.

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 consists of a metal tibial base without porous coating, and a locking polyethylene insert. Some metal components have modular stems, porous and non porous-coated sleeves and/or modular augments. The patella component is an all polyethylene design.

The ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors are designed as a component in the replacement of the natural articular surface of the knee joint or of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia. The ATTUNE Revision Sleeve LPS Femoral Adaptors are to be used to connect an ATTUNE Revision Femoral Sleeve to LPS System Components.

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The Freedom® Total Knee System is indicated for the following:

• Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Correction of functional deformities.
• Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, or prior patellectomy.
• Moderate valgus, varus, or flexion trauma.
• Knee fractures untreatable by other methods.
• Revision surgery where sufficient bone stock and soft tissue integrity are present (For PCK Components, and Primary PCK Components, and Metaphyseal Cones only).

The Freedom Porous Tibial Base Plate, and Cementless Femoral Components, and Metaphyseal Cones are indicated for Cemented or Uncemented use. All other components are indicated for cemented use only.

The Freedom Metaphyseal Cones are additionally indicated for use in addressing tibial bone voids and/or metaphyseal reconstruction.

The subject device, Freedom Knee Metaphyseal Cone implants, is a component addition to the cleared Freedom Total Knee System for addressing tibial bone voids and/or metaphyseal reconstruction. The Freedom Knee Metaphyseal Cone implants are designed with an elliptical shape, scaling larger in the Medial-Lateral (ML) direction than the Anterior-Posterior (AP) direction. The sizes are driven by the ML size, ranging from 25mm to 60mm wide in the ML direction and 29mm to 36mm AP in the AP direction. The cones are all 30mm long and feature a stepped design to further enhance the stability in the proximal-distal direction.

The Freedom Knee Metaphyseal Cone implants feature a large internal diameter to accept the largest possible Freedom Knee Stemmed Tibial Baseplate and Stem Extension possible. The internal diameters grow larger with each implant size, and all feature cement pockets to enhance the stability of the eventual TKA construct. The cone implants also feature 12mm wide relief slots to accept the fins/keel of the Freedom Knee Tibial Baseplate.

The AP and ML sides of the cone implants (which contact the metaphyseal bone) feature a 1mm thick proprietary scaffold structure. This structure, only possible via the additive manufacturing process, is designed to mimic the size and porosity of cancellous bone. The implant is comprised of Ti6Al4V ELI metal certified to ASTM F3001 and is manufactured with significant surface roughness to further add to the hydrophilic nature of the implant.

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