BETA
California biomaterials manufacturer developing synthetic absorbable gels for spine surgery and postoperative adhesion prevention.
Fziomed is a San Luis Obispo, California company founded in 1996. It develops and manufactures synthetic absorbable biomaterials using a dual-polymer platform based on carboxymethylcellulose and polyethylene oxide.
Its portfolio spans lumbar spine, tendon and peripheral nerve, intrauterine, and abdominal and pelvic procedures. Oxiplex is marketed in the United States; the other named families are offered in international markets.
Oxiplex received FDA De Novo classification on June 17, 2025, under DEN240038, followed by 510(k) K253326 on May 1, 2026. Its U.S. indication concerns adjunctive use in adult lumbar discectomy to reduce leg pain and neurological symptoms. [1][2][7]
Dynavisc and the Intercoat IU / Oxiplex IU and Intercoat AP / Oxiplex AP families are listed for international markets. Fziomed explicitly states these products are not available in the United States. [8][6][5]
Latest recorded source review: 2026-10-31.
Scope: selected product families.
Documented commercial product families.
Synthetic, absorbable carboxymethylcellulose and polyethylene oxide gel applied around nerves as an adjunct to adult lumbar discectomy to reduce leg pain and neurological symptoms. Supplied sterile in a syringe with an applicator. [7][1][2]
U.S. marketed · De Novo grant and subsequent 510(k)
Absorbable gel supplied in a 1 mL syringe to provide temporary separation around soft tissues and neural elements following tendon or peripheral nerve surgery. [8]
International markets · not available in the United States
Absorbable adhesion-barrier gel for intrauterine procedures, supplied with an applicator. Intercoat IU and Oxiplex IU are market-specific names for the family. [6]
International markets · not available in the United States
Absorbable adhesion-barrier gel for abdominal and pelvic procedures, provided in two 20 mL syringes with a laparoscopic applicator. [5]
International markets · not available in the United StatesFziomed began developing synthetic absorbable biomaterials in 1996. [3]
Accessed 10/31/2026
Last substantive review: 10/31/2026