FDA cleared the STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device from ETHICON, Inc. on Dec 22, 2025 under K252743, a traditional 510(k). The device falls under product code GAM, Suture, Absorbable, Synthetic, Polyglycolic Acid, regulated at 21 CFR 878.4493 as a Class 2 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on Aug 28, 2025. The decision came 116 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
ETHICON, Inc. has 6 other decisions in the tracker over the last 12 months: K253394 (Coated VICRYL (Polyglactin 910) Plus Antibacterial Suture), K252047 (STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices), K253572 (STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device), K253852 (MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture).