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The STRATAFIX™ Spiral PRONOVA™ Unidirectional Device is indicated for use in soft tissue approximation where the use of a non-absorbable barbed suture is appropriate, excluding closure of the epidermis.

The STRATAFIX™ Spiral PRONOVA™ Bidirectional Device is indicated for use in soft tissue approximation where the use of a non-absorbable barbed suture is appropriate, excluding closure of the epidermis.

The STRATAFIX™ Spiral PRONOVA™ Knotless Tissue Control Devices (KTCD) are monofilament, synthetic non-absorbable devices composed of a polymer blend of poly (vinylidene fluoride) and poly(vinylidene fluoride-co-hexafluoropropylene). The STRATAFIX™ Spiral PRONOVA™ KTCD are pigmented blue to enhance visibility in the surgical field. The STRATAFIX™ Spiral PRONOVA™ KTCD has two variations based on the orientation of the barbs and needle attachment: STRATAFIX™ Spiral PRONOVA™ Unidirectional KTCD and STRATAFIX™ Spiral PRONOVA™ Bidirectional KTCD.

The STRATAFIX™ Spiral PRONOVA™ Unidirectional KTCD consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The STRATAFIX™ Spiral PRONOVA™ Unidirectional Device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. The STRATAFIX™ Spiral PRONOVA™ Unidirectional Device barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.

The STRATAFIX™ Spiral PRONOVA™ Bidirectional KTCD Design consists of barbed suture material, armed with a surgical needle on each end. The device also contains an unbarbed center transition zone that facilitates the initiation of the device use. The STRATAFIX™ Spiral PRONOVA™ Bidirectional Device barbs allow for tissue approximation without the need to tie surgical knots.

The subject devices are for single-use and are sterilized by Ethylene Oxide. The subject devices are available in various lengths and USP diameter sizes armed with various needle sizes. STRATAFIX™ Spiral PRONOVA™ KTCD is intended for use only by Healthcare Professionals who are trained in surgical suturing techniques.

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