ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves; DePuy Sigma PS Femoral Components; DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components; S-ROM™ NOILES™ Rotating Hinge Knee System; DePuy P.F.C. ™ SIGMA™ Total Knee System; DePuy SIGMA™ Total Knee System;

ATTUNE™ Revision Knee System

Candidates for total knee replacement include patients with

• A severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis

• Moderate valgus, varus, or flexion deformities

• Avascular necrosis of the femoral condyle

• A previous unsuccessful knee replacement, osteotomy, or other knee procedure

ATTUNE Revision Knee System implants are designed for use in total knee arthroplasty for patients with:

• Absence or loss of both cruciate ligaments

• Moderate varus-valgus or flexion instability that requires a bearing surface with increased constraint in the clinical judgment of the surgeon

• Bone loss that requires supplemental fixation in the clinical judgment of the surgeon

The porous-coated metaphyseal sleeves are intended for either cemented or cementless applications.

ANY NON POROUS-COATED COMPONENTS ARE INTENDED FOR CEMENTED USE ONLY.

DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral Metaphyseal Sleeves

The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are intended for use with the PFC, PFC Sigma, Sigma TC3 Revision Knee, or S-ROM knee prosthesis in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. These devices are for cemented use only.

The DePuy Universal Femoral Metaphyseal Sleeve and Universal Stem components are also intended for use with the DePuy LPS prosthesis for 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, gian cell tumors, bone tumors) requiring extensive resection and replacement; patient conditions of noninflammatory degenerative join disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g. rheumatoid arthritis, requiring extensive resection and replacement; revision for failed previous prosthesis cases requiring extensive resection and replacement. The LPS prosthesis is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The Universal Stem and the Universal Metaphyseal Sleeve components are intended for cemented use only.

DePuy Sigma PS Femoral Components and DePuy Sigma Cruciate Retaining (C/R) Porocoat Femoral Components

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.

Total knee replacement may be considered for younger patients if, in the opinion of the surgeon, an unequivocal indication for total knee replacement outweighs the risks associated with the age of the patient, and if limited demands regarding activity and knee joint loading can be assured. This includes severely crippled patients with multiple joint involvement for whom a gain in knee mobility may lead to significant improvement in the quality of their lives.

THE SIGMA C/R POROCOAT® FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED OR CEMENTLESS USE AS THE FEMORAL COMPONENT OF A TOTAL KNEE REPLACEMENT SYSTEM.

THE SIGMA PS FEMORAL COMPONENTS ARE INTENDED FOR CEMENTED USE AS THE FEMORAL COMPONENTS OF A TOTAL KNEE REPLACEMENT SYSTEM.

S-ROM™ NOILES™ Rotating Hinge Knee

The S-ROM NOILES Rotating Hinge Knee is indicated in cases for cement use in patients who have reached skeletal maturity and for whom the surgeon has decided to resect both cruciate ligaments due to the following conditions:

1. Severe instability, gross deformity and/or bone loss.

2. Failure of a previous knee reconstruction procedure.

3. Trauma or tumor resection.

4. Absent or markedly insufficient collateral ligaments.

DePuy P.F.C. ™ SIGMA™ Total Knee Prosthesis and DePuy SIGMA™ Total Knee Prosthesis

The DePuy SIGMA™ and P.F.C. ™SIGMA™ Total Knee Prosthesis are intended for use in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention.

The DePuy SIGMA™ and P.F.C. ™SIGMA™ Total Knee Prosthesis are intended for cement use only.