TSolution One® Total Knee Arthroplasty

This clinical investigation will be conducted as a prospective, non‐randomized, multicenter
study. The primary objective of this study is to demonstrate that the TSolution One System is
safe and effective for use as an alternative to manual planning and sawing/cutting
techniques. The primary effectiveness objective of this study is to demonstrate that the
TSolution One® System is effective for use as an alternative to manual planning and
sawing/cutting techniques by comparing the rate of malalignment for mechanical axis greater
than 3° at 3 months to the rate reported in the literature (i.e. 32%) and to demonstrate
significant clinical benefit by reducing the number of malaligned patients by at least 50%
(i.e. from 32% to ≤ 16%). The safety objective of this study is based on the rate of
intraoperative and postoperative TKA complications, with a follow-up period of no less than 6
months and no more than 12 months, and to compare this rate to the rate reported in the
literature. The secondary objective of this study is to summarize the distribution of
improvements in patients' self-reported assessment of postoperative function and
quality-of-life from baseline to a maximum of 12 months. Additionally, other preoperative
planning alignment goals (e.g. Knee V‐V Alignment; Femoral Joint Line Alignment Angle; Tibial
Joint Line Alignment Angle; Tibial Slope Angle) will be compared to the post‐operative
alignment at 3 months.

Investigators will recruit subjects from patients in their practice who require unilateral
total knee arthroplasty. Patients will be screened to identify eligible candidates based on
the inclusion and exclusion criteria. A total of one hundred fifteen (115) patients will be
enrolled in the study across the participating sites. All patients will sign an informed
consent form prior to participating in the study.

Prior to undergoing the investigational procedure, the patients will complete baseline
surveys of function and quality of life (Knee Society Score survey and the SF‐12 Health
Survey) and have baseline radiographs and a CT scan of the knee.

Each patient will then undergo robotic‐assisted total knee arthroplasty with the TSolution
One® System. The investigators will evaluate intra‐ and postoperative complications.
Postoperative radiographs and a CT scan will be used to measure limb alignment using a
standardized radiographic evaluation protocol. Each patient will complete a postoperative
Knee Society Score survey and the SF‐12 Health Survey to assess functional outcomes and
quality‐of‐life following the investigational procedure.

Inclusion Criteria:

1. At least 21 years of age.

2. Skeletally mature, as evidenced by closed epiphyses.

3. Eligible for primary unilateral TKA due to osteoarthritis defined radiographically by
a Kellgren‐Lawrence Grade of 3 or higher.

4. Able to understand and willing to comply with the requirements of the study.

5. Able to give voluntary, written informed consent to participate and has signed an
Informed Consent Form specific to this study.

Exclusion Criteria:

1. Has undergone previous open knee surgery in the operative knee.

2. Has a body mass index (BMI) > 40 kg/m2.

3. Is a candidate for bilateral TKA.

4. Has a coronal deformity greater than 20° or a sagittal flexion contracture greater
than 15°.

5. Has an active systemic infection or an active local infection in or near the operative
knee joint, or has a previous history of joint infection.

6. Has a pathological skeletal condition or skeletal immaturity which would significantly
compromise the ability of the bone to withstand the stress required for preparation of
the bones and proper implantation of the prostheses (e.g., severe osteoporosis,
Paget's disease, renal osteodystrophy, AVN, sickle cell disease, etc.).

7. Has femoral or tibial bone stock that is of poor quality or inadequate to provide
stability for femoral or tibial fixation.

8. Has any type of metallic implant in the operative leg.

9. Has a known or suspected sensitivity to any of the materials in the investigational
device or implant components (i.e. cobalt, chromium, titanium, stainless steel,
titanium nitride, aluminum, polyethylene, PVC plastic)

10. Has a systemic illness or a neuromuscular, neurosensory, or musculoskeletal deficiency
that would render the patient unable to perform appropriate postoperative
rehabilitation.

11. Has a neuromuscular disorder that would create an unacceptable risk of prosthesis
instability or fixation failure.

12. Has significant comorbidities or conditions associated with high risk for surgical or
anesthetic survival (e.g. peripheral vascular disease, unstable cardiac disease,
poorly controlled diabetes, immunosuppression, etc.).

13. Is pregnant or intends to become pregnant during the course of the study.

14. Has previously experienced a stroke.

15. Is participating concurrently in another clinical trial, or has participated in a
clinical trial within the last 90 days, or intends to during the course of the study.

16. Has a medical or psychiatric condition which, in the opinion of the investigator,
poses a risk of the patient being unable to complete the study or presents risks
associated with study participation.