This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Oxford™ Meniscal Unicompartmental Knee System
Applicant: Biomet Orthopedics, Inc.
Address: P.O. Box 587
Warsaw, Indiana 46580
Approval Date: April 21, 2004
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf/p010014a.pdf
What is it? The Biomet Oxford™ Meniscal Unicompartmental Knee System is an artificial mobile bearing knee system that replaces one side of the knee joint. The system has three parts:
- A metal curve-shaped part (femoral component), which a doctor cements onto the end of the thigh bone,
- A flat metal ‘tray’ that is cemented onto the top of the shin bone (tibia), and
- A plastic support (bearing) that sits on the tibial tray and joins with the curved femoral component.
The plastic bearing slides in between the tibial tray and femoral component, which allows this artificial knee joint to move.
When is it used? A doctor uses this device in a patient who needs a partial knee replacement due to osteoarthritis or avascular necrosis that is limited to the inside (medial) part of the knee. Examples of osteoarthritis and avascular necrosis are:
- wearing out of the joint due to age, and
- lack of blood flow to the bone.
What will it accomplish? The Oxford™ Meniscal Unicompartmental Knee System will:
- reduce pain by replacing the painful arthritic portion of the knee joint, and
- restore movement of the knee joint.
When shouldn’t it be used? A doctor should not use the Oxford™ Meniscal Unicompartmental Knee System in a patient who has:
- an infection,
- rheumatoid arthritis (inflammatory condition that typically affects the whole joint) or other forms of inflammatory joint disease in the knee,
- had a prior knee implant,
- failed upper tibial osteotomy or post-traumatic arthritis after tibial plateau fracture,
- damaged or missing ligaments in the knee,
- disease or damage to the outside (lateral) part of the knee,
- osteoporosis and the patient’s doctor believes it may affect the knee prosthesis,
- disease or metabolic disorder (such as osteomalacia, vascular insufficiency, muscular atrophy, neuromuscular disease, or Charcot’s disease) that may impair bone formation and affect the outcome of knee implant surgery,
- rapid joint destruction, marked bone loss or bone resorption visible on x-ray,
- incomplete or deficient soft tissue surrounding the knee,
- fixed varus deformity (not passively correctable) of greater than 15°,
- flexion deformity greater than 15°, or
- is unable to follow a doctor’s instruction.
Additional information: Summary of safety and effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p010014