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: Total Temporomandibular Joint Replacement System
Manufacturer: Walter Lorenz Surgical, Incorporated
Address: 1520 Tradepost Drive, Jacksonville, Florida 32218-2480
Approval Date: September 21, 2005
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf2/p020016a.pdf
What is it? The Total Temporomandibular Joint Replacement System is a prosthetic jaw joint.
How does it work? The device is a ball and socket joint with one side mounted to the jaw and the other side mounted to the head in front of the ear. A surgeon implants the joint after removing any old devices, unsuccessful grafts, and badly damaged bone.
When is it used? The device is used for patients who need a total jaw replacement due to one or more of the following conditions:
- severe arthritic conditions
- fused joints
- previous multiple surgeries
- severe fractures
- severely degenerated joints
- severe developmental abnormalities that cannot be treated by other means
What will it accomplish? The device may reduce jaw pain, reduce interference with eating and increase the ability to open the mouth. Patients who have had many previous jaw surgeries may have more complications during joint reconstruction.
When should it not be used? The device should not be used for partial TMJ joint reconstruction, or if the patient:
- has an active or chronic infection
- has insufficient bone to support the device
- has a systemic disease with increased susceptibility to infection
- has an allergy to any materials used in the device
- has mental or neurological conditions, and is unwilling or unable to follow postoperative care instructions
- is skeletally immature
- has severe hyper-functional habits (e.g. clenching or grinding teeth).
- has a foreign body reaction due to previous implants
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p020016