ATTUNE Single-Use Instrumentation vs. ATTUNE Reusable Instrumentation in Primary Total Knee Arthroplasty

This study is designed as comparative, sequential, non-randomized, multi-center
investigation.

Up to four sites will recruit approximately 88 subjects. Each site is expected to implant the
ATTUNE primary cemented total knee in approximately 22 subjects. The sequential design
requires all ATTUNE TKA with reusable instruments be completed before doing any ATTUNE TKA
with single use instruments.

The mechanical axis alignment will be assessed at the 3 month follow-up by independent
radiographic review.

Inclusion Criteria:

1. Subjects with severely painful and/or severely disabling Non-inflammatory Degenerative
Joint Disease (NIDJD) resulting from osteoarthritis (OA) or post-traumatic arthritis.

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

3. Subject requires a primary total knee replacement and is considered by the
Investigator to be suitable for the specific knee prosthesis identified in the
protocol.

4. Subject, who, in the opinion of the Investigator, is suitable for implantation using
either RUI or SUI instrumentation.

5. Subject is able to speak and read English to facilitate comprehension of the Informed
Consent Document.

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

7. 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.

Exclusion Criteria:

1. The Subject has, in the opinion of the Investigator, a severe deformity that will
hinder achieving a mechanical axis alignment target of 0° ± 3°.

2. The Subject has, in the opinion of the Investigator, an existing condition that would
compromise their participation and follow-up in this study.

3. The Subject has, in the opinion of the Investigator, a flexion deformity that will not
allow for 0° extension postoperatively.

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

5. The 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 follow-up care or
treatment outcomes.

6. The Subject has participated in a clinical investigation with an investigational
product in the last 3 months.

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

8. The Subject has previous prosthetic knee replacement (any type including
unicompartmental, total knee arthroplasty, patellofemoral arthroplasty or ipsilateral
UTO/HTO) of the affected knee or a previous patellectomy.

9. The Subject presents with ankylosis of the hip joint on the side to be treated.

10. The Subject had a contralateral TKA and that knee was previously entered into the
study.

11. The Subject requires simultaneous bilateral total knee replacements.

12. Any case in which Computer-Assisted Surgery (CAS) or TruMatch (or any other type of
Custom Patient Instruments) is to be used, or any additional instrumentation are to be
used for bone resections that are not provided as part of the ATTUNE RUI or SUI
Instrument kits.

13. The Subject requires a device not specified in the protocol or the surgeon determines
that the ATTUNE Knee System is not a suitable treatment.