In Reply

Abstract

We thank the author for his kind comments regarding our article, “Scapholunate instability: current concepts in diagnosis and management,”1Kitay A. Wolfe S.W. Scapholunate instability: current concepts in diagnosis and management.J Hand Surg Am. 2012; 37: 2175-2196Abstract Full Text Full Text PDF PubMed Scopus (142) Google Scholar as well as his comprehensive review of the Food and Drug Administration position on off-label use of prosthetic implants. Although certain radial wrist hemiarthroplasty devices are approved for use in humans in Europe under an approved Conformité Européenne mark, the author correctly notes that radial wrist hemiarthroplasty implants are not approved by the Food and Drug Administration for use in America. Dr. Kitay and I wish to make the readership of the Journal of Hand Surgery aware of this fact, and apologize for our omission of this notation in our article. A radial wrist hemiarthroplasty may only be performed in the United States as an off-label use with full patient understanding and the appropriate institutional review board approval, as applicable. We thank the author for his kind comments regarding our article, “Scapholunate instability: current concepts in diagnosis and management,”1Kitay A. Wolfe S.W. Scapholunate instability: current concepts in diagnosis and management.J Hand Surg Am. 2012; 37: 2175-2196Abstract Full Text Full Text PDF PubMed Scopus (142) Google Scholar as well as his comprehensive review of the Food and Drug Administration position on off-label use of prosthetic implants. Although certain radial wrist hemiarthroplasty devices are approved for use in humans in Europe under an approved Conformité Européenne mark, the author correctly notes that radial wrist hemiarthroplasty implants are not approved by the Food and Drug Administration for use in America. Dr. Kitay and I wish to make the readership of the Journal of Hand Surgery aware of this fact, and apologize for our omission of this notation in our article. A radial wrist hemiarthroplasty may only be performed in the United States as an off-label use with full patient understanding and the appropriate institutional review board approval, as applicable. “Off-Label” Use of Orthopedic Implants in the WristJournal of Hand SurgeryVol. 38Issue 2PreviewImplants are used in the upper limb for disease and injury. The majority of new pins, rods, plates, screws, and joint replacement implants are approved by the Federal Food and Drug administration (FDA) through a process defined in May 1976 as the Safe Medical Device Act or 510K process. The latter requires a “predicate” device, or equivalent implant, previously approved for development and marketing by the FDA before 1976. An example is a prosthetic replacement of a carpal bone with metal or pyrolytic carbon implant, which is based on the prior approval of silicone implants. Full-Text PDF