Prospective, Multiconfiguration Study to Assess Functional Performance of Primary Total Knee Arthroplasty System

The study is designed as a prospective, single arm stratified, multi-center investigation.

Approximately 20 study sites, worldwide, will enroll 1040 subjects (1040 knees). Each study
is expected to enroll approximately 52 subjects (approximately 52 knees). An additional 10
subjects per site may be recruited at sites which have Sub-Investigators participating in the
study. Cohort reallocation is permitted. There will be no control group. One thousand and
forty (1040)Subjects will be stratified into 4 subgroups of 260: cruciate retaining fixed
bearing(CR FB), posterior stabilized fixed bearing (PS FB), cruciate retaining rotating
platform (CR RP), and posterior stabilized rotating platform (PS RP). Treatment assignment in
this study is not randomized.

Each site will only enroll patients in one of the four knee configuration sub-groups most
commonly used as their standard of care.

Inclusion Criteria:

- Subject is male or female and between the ages of 22 and 80 years, inclusive.

- Subject was diagnosed with NIDJD.

- Subject is a suitable candidate for cemented primary TKA using the devices described
in the Clinical Investigation Plan (CIP)with either resurfaced or non-resurfaced
patellae.

- Subject has given voluntary, written informed consent to participate in this clinical
investigation and has authorized the transfer of his/her information to DePuy.

- Subject is currently not bedridden.

- Subject, in the opinion of the Clinical Investigator, is able to understand this
clinical investigation and co-operate with investigational procedures.

- Subject must be comfortable with speaking, reading, and understanding questions and
providing responses in an available translated language for the PROs in the CIP.

- The devices specified in this CIP were implanted.

Exclusion Criteria:

- The Subject is a woman who is pregnant or lactating.

- Contralateral knee has already been enrolled in this study.

- Subject had a contralateral amputation.

- Previous partial knee replacement (unicompartmental, bicompartmental or patellofemoral
joint replacement), patellectomy, high tibial osteotomy or primary TKA in affected
knee.

- Subject is currently experiencing radicular pain from the spine.

- Subject has participated in an IDE/IND clinical investigation with an investigational
product in the last three months.

- Subject is currently involved in any personal injury litigation, medical-legal or
worker's compensation claims.

- Subject is a known drug or alcohol abuser or has a psychological disorder that could
affect their ability to complete patient reported questionnaires.

- Subject was diagnosed with fibromyalgia that is currently being treated with
prescription medication.

- Subject has significant neurological or musculoskeletal disorders or disease that may
adversely affect gait or weight bearing (e.g. muscular dystrophy, multiple sclerosis,
Charcot disease).

- Subject is suffering from inflammatory arthritis (e.g. rheumatoid arthritis, juvenile
rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, etc.).

- Subject is not comfortable with speaking, reading, and understanding questions and
providing responses in an available translated language for the PROs in the CIP.

- Subject has a medical condition with less than 2 years of life expectancy.