Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty

Inclusion Criteria:

- Subject is 18 to 80 years of age inclusive at the time of screening

- Subject is planned for primary unilateral total knee arthroplasty

- Subject has signed the informed consent form

- Subject is in stable health (i.e., able to undergo surgery and participate in a
follow-up program based on physical examination and medical history)

- Subject has a preoperative Hgb level > 10 g/dL

- If female of childbearing potential, the subject presents with a negative urine
pregnancy test and agrees to employ adequate birth control measures for the duration
of the study

- Subject is willing and able to comply with the requirements of the protocol

Exclusion Criteria:

- Subject has had a previous total or partial knee arthroplasty or any surgery on the
knee within the previous 6 months

- Subject has osteonecrosis or arthrotomy within the last year

- Subject has prior or current hardware in target knee

- Subject has had injections in the knee:

1. Steroids within the 3 months prior to scheduled surgery,

2. Synvisc, Hyalin, etc. within the 6 months prior to scheduled surgery

- Subject has had general surgery within 3 months

- Subject has rheumatoid arthritis or any other inflammatory or traumatic bone injuries
to the knee within the 12 months prior to scheduled surgery

- Subject has allergies to products of bovine origin

- Subject has a history of bleeding, platelet, or bone marrow disorders

- Subject has donated more than 1 unit of blood donation in the 3 weeks prior to
surgery

- Subject has a history of a coagulation disorder

- Subject is currently taking dipyridamole/ASA (Aggrenox) and/or enoxaparin (Lovenox)

- Subject has been treated with aspirin or Warfarin (Coumadin) or clopidogrel (Plavix)
within 7 days prior to surgery

- Subject is not permitted to remain without his/her anti-coagulant regimen (e.g.
Plavix) for 48 hours postoperatively

- subject has taken nonsteroidal anti-inflammatory agents or herbal supplements within
7 days of surgery

- Subject has a history of substance abuse (alcohol, drugs) or is an active smoker

- Subject has liver cirrhosis

- Subject has erythropoietin agonist/stimulating agent within 90 days prior to surgery

- Subject has an active infection or previous history of infection in the affected
joint within the previous 6 months

- Subject has participated in another clinical study involving an investigational
product (IP) or device within 30 days prior to study enrollment or is scheduled to
participate in another clinical study involving an IP or device during the course of
this study