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510(k) Data Aggregation
K Number
K222501Device Name
Regeneten Bioinductive Implant
Manufacturer
Smith and Nephew Inc
Date Cleared
2023-05-11
(266 days)
Product Code
OWY, ORQ
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Smith and Nephew Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Regeneten Bioinductive Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.
Device Description
Regeneten Bioinductive Implant is a resorbable type I bovine Achilles-derived collagen implant that provides a layer of collagen over injured tendons. The device is designed to provide a layer between the tendon and the surrounding tissue during healing. The device features a large porosity design with a low tensile modulus to allow for recipient tissue ingrowth into the implant at the repair site for natural remodeling and the passive formation of collagen over injured tendons. The physical structure and placement of Regeneten Bioinductive Implant provides and supports an environment for healing. When hydrated, Regeneten Bioinductive Implant is an easy-to-use, soft, pliable, nonfriable, porous implant. Regeneten Bioinductive Implant is provided as a sterile, single-use device in a variety of sizes. The arthroscopic configuration of the Bioinductive implant is preloaded in a cartridge and packaged in a sterile, dual seal tray-in-tray configuration.
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