Johnson & Johnson Medical, Inc.

Johnson & Johnson Medical, Inc. specializes in surgical devices used in reconstructive and repair procedures. Their portfolio includes bioabsorbable polyester sutures, such as coated multifilament varieties like Coated VICRYL, which dissolve over time after use. They also produce reusable suturing needle holders for precise stitching during surgery. Additionally, the company manufactures composite-polymer surgical meshes, including products like ARTISYN and ULTRAPRO, designed for extra-gynaecological and pelvic organ prolapse applications to support tissue repair.

Johnson & Johnson Medical, Inc. is based in the United States, which means its devices fall under the jurisdiction of the FDA (U.S. Food and Drug Administration). The FDA classifies their products into categories like Class I (low-risk), Class II (moderate-risk requiring special controls), and Unclassified (U), depending on their intended use and potential risks. This classification determines the regulatory pathway, such as 510(k) clearance for Class II devices or PMA for higher-risk products.

Johnson & Johnson Medical, Inc.’s devices are listed in the FDA’s 510(k), PMA, and UDI registries. The 510(k) pathway is used for Class II devices to demonstrate substantial equivalence to a predicate device, while PMA (Premarket Approval) applies to higher-risk Class III devices requiring rigorous clinical evidence. The UDI (Unique Device Identifier) registry ensures traceability and transparency in the supply chain, allowing healthcare providers and regulators to track devices throughout their lifecycle.

The FDA classifies Johnson & Johnson Medical, Inc.’s devices into Class I (general controls sufficient, e.g., some sutures), Class II (requires additional performance standards, e.g., coated sutures or mesh), and Unclassified (U) (new or investigational devices awaiting classification). Class II devices, like their composite-polymer meshes, require pre-market submissions (e.g., 510(k)) to ensure safety and effectiveness before commercialization, while Class I devices may only need basic compliance with FDA regulations.

Johnson & Johnson Medical, Inc. manufactures composite-polymer surgical meshes, including products like ARTISYN and ULTRAPRO, which are designed for reconstructive surgeries. These meshes are used in extra-gynaecological (e.g., hernia repair) and pelvic organ prolapse procedures to provide structural support to weakened tissues. Their composite materials aim to integrate with surrounding tissue while maintaining durability during healing.