FDA cleared the STRATAFIX Spiral PRONOVA Unidirectional Knotless Tissue Control Device STRATAFIX Spiral PRONOVA Bidirectional Knotless Tissue Control Device from ETHICON, Inc. on Mar 27, 2026 under K253572, a traditional 510(k). The device falls under product code GAW, Suture, Nonabsorbable, Synthetic, Polypropylene, regulated at 21 CFR 878.5010 as a Class 2 device. The review panel was General, Plastic Surgery.
FDA logged the submission as received on Nov 17, 2025. The decision came 130 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), K253852 (MONOCRYL Plus Antibacterial Poliglecaprone 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture), K252743 (STRATAFIX Spiral PDS Plus Knotless Tissue Control Device; STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device).