Bioabsorbable fixation devices: status for the craniomaxillofacial surgeon.
With time, more and more types of medical devices become available to assist the surgeon in managing patients. Bioabsorbable fixation devices, which have been directed toward the orthopedic surgeon over the past 10 years, are but one example. One aim of this article is to present the current status of bioabsorbable devices in medical practice to the craniomaxillofacial surgeon who may not be aware of the inroads this technology has made. A bioabsorbable fixation system has become available for use by the craniomaxillofacial surgeon, which is described. A further aim of this article is to present concisely the testing rigor required of such devices before their introduction to the U.S. market. This has the added benefit of explaining the important role of the surgeon in developing and helping reduce to standard clinical practice the use of new technologies.
Pietrzak
W S
WS
Biomet, Inc., Warsaw, IN 46581, USA.
Verstynen
M L
ML
Sarver
D R
DR
D020341:Absorbable Implants; D001672:Biocompatible Materials / Q000737:chemistry*; D001860:Bone Plates; D001863:Bone Screws; D003399:Craniotomy / Q000295:instrumentation*; D018795:Device Approval / Q000331:legislation & jurisprudence; D006801:Humans; D016268:Internal Fixators; D019344:Lactic Acid; D008422:Materials Testing; D011100:Polyglycolic Acid; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011108:Polymers; D014481:United States; D014486:United States Food and Drug Administration
D001672:Biocompatible Materials; D011108:Polymers; D000077182:Polylactic Acid-Polyglycolic Acid Copolymer; D011100:Polyglycolic Acid; D019344:Lactic Acid