FortiShield (Biosynthetic Wound Matrix) (K212579) - FDA 510(k) Clearance

K212579 is an FDA 510(k) clearance for the FortiShield (Biosynthetic Wound Matrix). Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Organogenesis, Inc. (Canton, US). The FDA issued a Cleared decision on May 2, 2023 after a review of 624 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Organogenesis, Inc. devices