(125 days)
The Balanced Knee® System Revision is intended for cemented use only in knee arthroplasty procedures whose indications include:
- Loss of joint configuration and joint function.
- Osteoarthritis of the knee joint.
- Rheumatoid arthritis of the knee joint.
- Post-traumatic arthritis of the knee joint.
- Moderate valgus, varus, or flexion deformities.
- Revision procedures where other treatments or devices have failed
The Balanced Knee® System Revision is indicated in the salvage of previously failed surgical attempts where femoral bone loss may require the use of augments or stem extensions.
Not Found
I am sorry, but based on the provided document, the information required to answer your request is not present. This document is a 510(k) clearance letter from the FDA for the "Balanced Knee System Revision" and details its indications for use. It does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.