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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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The Signature Orthopaedics' Cambridge Partial Knee is designed for a single compartment replacement of the natural knee joint. The Cambridge Partial Knee is indicated for cemented use in partial knee arthroplasty procedures. Partial replacement of the articulating surfaces of the knee is indicated only when only one compartment of the joint is affected due to the compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The Cambridge Partial Knee is a unicompartmental knee system consisting of a femoral component and tibial component (meniscal insert overmoulded onto the tibial baseplate). The femoral and tibial components are intended for use with bone cement. The implant is for fixed partial knee replacement. Each size tibial implant has two variants, right lateral/left medial (RLLM) and right medial/left lateral (RMLL) condyle.

The femoral component is a spherical, symmetrically designed prosthesis manufactured from cast cobalt chrome (CoCrMo). The meniscal bearing and tibial baseplate are a monobloc fixed tibial bearing consisting of a titanium (Ti6Al4V) baseplate overmoulded with UHMWPE GUR1020-E. The meniscal bearing is moulded over the tibial baseplate and machined to the correct size and geometry.

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