Self-Forming Magnet (Flexagon Plus OTOLoc)

The Flexagon Plus OTOLoc System is a magnetic compression anastomosis device used to create side-to-side connections between small bowel segments (jejunum-to-jejunum or ileum-to-ileum) during minimally invasive laparoscopic surgery. The device uses self-forming magnets that align due to opposing polarity, compress tissue to create the connection, and are naturally expelled from the body in 3-6 weeks once the anastomosis is healed. It is intended for adult patients over 21 years old.

The Flexagon Plus OTOLoc maintains identical magnetic strength to the cleared predicate Flexagon SFM, as the self-forming magnets are unchanged. The key addition is the OTOLoc component, which preserves the enterotomy (opening) to permit immediate fluid flow through the intestinal lumen upon implantation—a feature already established in other cleared devices like Valtrac and the NiTi Compression Anastomosis Clip. The alternating dipoles prevent improper apposition while allowing the body to control healing timing.

ISO 10993 series (cytotoxicity, sensitization, irritation, acute/chronic toxicity, genotoxicity, implantation); ISO 11137-1:2006 and EN ISO 11137-1:2015 (radiation sterilization validation); ASTM D 4169:2022 (transportation and shipping); ISO 10993-18 and ISO 10993-17 (chemical characterization and leachable substance limits).

The device is substantially equivalent because it performs the same surgical function using the same magnetic compression technology as the primary predicate (Flexagon SFM, K243482) with identical magnetic strength and intended use. The OTOLoc feature—enabling immediate luminal flow—replicates functionality already cleared in predicate devices Valtrac and NiTi CAC. Performance testing using identical methods to the predicate shows the device meets or exceeds safety and effectiveness benchmarks, with clinical data from 84 patients demonstrating no anastomotic leakage, bleeding, obstruction, or deaths—performance at least as safe as commercially available devices and the predicate.