Evaluation of Commercially Available Knee Cartilage Restoration Techniques Stratified by FDA Approval Pathway.

Background: Commercially available products used in knee cartilage reconstructive and restorative surgical practices fall under unique US Food and Drug Administration (FDA) regulatory pathways that determine the level of evidence required to market each product.

Purpose: To evaluate the levels of evidence in the literature supporting commercially available cartilage repair procedures stratified by FDA regulatory pathway (section 351 vs section 361 of "Human Cells, Tissues, and Cellular and Tissue-Based Products" [HCT/P] in the Code of Federal Regulation) with the hypothesis that products requiring approval under a stringent regulatory pathway (351 HCT/P) have higher levels of evidence in the literature supporting use and that products with a less stringent regulatory pathway (361 HCT/P) have a higher number of products available for use in the United States.

Study Design: Systematic review; Level of evidence, 4.