14022 ATTUNE Cementless RP Clinical Performance Evaluation

The secondary objectives of this study are:

- Evaluate change from preoperative baseline in post-operative outcomes using additional
patient reported measures at 2 years: PKIP (overall and sub-scores), KOOS (overall and
sub-scores), AKS and EQ-5D-3L.

- Evaluate change from preoperative baseline in pain and satisfaction over time as
measured using a modified VAS Pain Score (discrete numbers rather than a continual
scale) at 2yr.

- Evaluate type and frequency of Adverse Events

- Evaluate survivorship of the ATTUNE Primary Cementless TKA system for the CR RP and PS
RP configurations using Kaplan-Meier survival analysis at 2yr and 5yrs.

- Evaluate primary, cementless ATTUNE TKA fixation through zonal radiographic analysis of
the bone-implant interface at 6wk, 6mo, 1yr, and 2yr after surgery.

- Evaluate any changes in anatomic tibiofemoral, femoral component and tibial component
alignment at 2 years compared to the first postoperative radiographs.

Inclusion Criteria:

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

- Subject was diagnosed with NIDJD.

- Subject, in the opinion of the Investigator, is a suitable candidate for cementless
primary TKA using the devices described in this CIP with either resurfaced or
non-resurfaced patellae.

- Subject that is willing to give voluntary, written informed consent to participate in
this clinical investigation and authorize the transfer of his/her information to the
Sponsor

- Subject is currently not bedridden

- Subject, in the opinion of the Investigator, is able to understand this clinical
investigation and is willing and able to perform all study procedures and follow-up
visits and co-operate with investigational procedures.

- Subject is able to read, and comprehend the Informed Consent Document as well as
complete the required PROs in either English or one of the available translations.

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 diagnosed with radicular pain from the spine that radiates into
the limb to receive TKA.

- Subject has participated in a clinical investigation with an investigational product
(drug or device) in the last three (3) months.

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

- Subject, in the opinion of the Investigator, is a drug or alcohol abuser (in the last
5 years) or has a psychological disorder that could affect their ability to complete
patient reported questionnaires or be compliant with follow-up requirements.

- Subject was diagnosed and is taking prescription medications to treat a muscular
disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or
polymyalgia.

- Subject has a significant neurological or musculoskeletal disorder(s) 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 has a medical condition with less than five (5) years life expectancy.

- Uncontrolled gout