STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device

The STRATAFIX™ Spiral PRONOVA™ Knotless Tissue Control Devices are non-absorbable barbed surgical sutures made from a polymer blend of polyvinylidene fluoride and polyvinylidene fluoride-co-hexafluoropropylene. They are available in unidirectional (single-armed with fixation loop) and bidirectional (double-armed) variants and are indicated for soft tissue approximation without the need to tie surgical knots, excluding epidermal closure.

The subject devices are monofilament, synthetic non-absorbable sutures with mechanically barbed surfaces cut into the core, pigmented blue for visibility. The unidirectional variant has unidirectional barbs and a welded loop anchor; the bidirectional variant has opposite-facing barbs from a non-barbed center transition zone. Both are sterilized by ethylene oxide and available in various USP sizes and needle configurations.

USP <861> Suture Diameter, USP <871> Suture Attachment, USP <881> Tensile Strength, ISO 10993-1 Biological Evaluation of Medical Devices, and FDA's Class II Special Controls Guidance Document: Surgical Sutures (June 3, 2003).

The subject devices are substantially equivalent to the QUILL™ predicate devices (K052373 and K151112) and PRONOVA™ reference material (K001625) based on identical indications (soft tissue approximation excluding epidermis), comparable technological means (mechanically barbed monofilament strands for knotless tissue approximation), same material composition and colorant, equivalent mechanical properties, and performance testing demonstrating wound holding capability equivalent to predicates with no new safety or effectiveness concerns.