K142879 - BTM Wound Dressing (FDA 510(k) Clearance)

K142879 is an FDA 510(k) clearance for the BTM Wound Dressing. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Polynovo Biomaterials Pty, Ltd. (Port Melbourne, AU). The FDA issued a Cleared decision on December 23, 2015 after a review of 447 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 Polynovo Biomaterials Pty, Ltd. devices