The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Friday, November 14, 2008 at the Hilton Washington DC North/Gaithersburg located at 620 Perry Parkway in Gaithersburg, Maryland. The Panel met in order to provide advice and a recommendation on the 510(k) application submitted by ReGen Biologics, Inc., for their Collagen Scaffold (CS) (K082079). This device is intended for use in surgical procedures for the reinforcement and repair of chronic soft tissue injuries of the meniscus (one to three prior surgeries to the involved meniscus) where weakness exists. In repairing and reinforcing meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the CS must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.
The meeting began with an open public hearing session, followed by presentations from the sponsor and FDA. The presentations focused on clinical data from the sponsor’s IDE, clinical data described in a 2008 journal publication, and the sponsor’s claimed predicate devices.
The Panel discussed and commented on FDA questions related to the mechanical integrity of the ReGen CS for its intended use, its ability to foster tissue ingrowth, specific clinical issues related to the use of the ReGen CS in the knee, its safety and effectiveness in comparison to the claimed predicate devices, and its appropriateness for acute soft tissue injury. The Panel generally believed that the ReGen CS was able to withstand physiological forces, would foster ingrowth of unorganized fibrocartilage tissue, was appropriate for both acute and chronic meniscal soft tissue injuries, and was as safe and effective as the predicate devices. However, the Panel cautioned that there will be confounding patient and operator factors that makes patient selection and operator training critical elements in the use of the ReGen CS. The Panel also recommended that a training course be offered for the device to evaluate surgical skills, and that the acute indication should be carefully defined.
Contact: Ronald P. Jean, Ph.D., Executive Secretary, at 240-276-3676 or firstname.lastname@example.org.
Transcripts of this meeting may be purchased from (written request only):
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