Natrelle 133S Tissue Expanders

The Natrelle 133S Tissue Expander is a silicone elastomer device designed to develop tissue flaps for two-stage breast reconstruction following mastectomy, treatment of underdeveloped breasts, and correction of soft tissue deformities. It is temporarily implanted subcutaneously or submuscularly for no longer than six months and is filled with sequential saline injections to gradually expand the overlying tissue.

The device has the same fundamental technological characteristics as the predicate: a smooth silicone expansion envelope that expands with saline injections, an integrated self-sealing magnetic injection site (MAGNA-SITE) locatable via an external magnetic device (MAGNA-FINDER Xact), and a titanium needle guard. The only difference from the predicate is that a 21-Gauge needle infusion set accessory is not included in the packaging; all dimensions, materials, and device features otherwise remain identical.

Not stated in this summary.

The Natrelle 133S Tissue Expander is substantially equivalent to the predicate device (K182054) because it shares the same intended use, indications for use, and fundamental scientific technology. Risk analysis and design control procedures demonstrated that the device design does not raise different safety or effectiveness questions, and the only packaging change (removal of a needle accessory) does not impact the core device function or safety profile.