Dissolvable Skin Stapler for Orthopedic Surgery

Yes. SubQ It! holds FDA 510(k) clearance (K131563) specifically for closing incisions in orthopedic, abdominal, thoracic, gynecologic, plastic, and reconstructive surgery. The manufacturing facility is also ISO 13485 registered, ensuring full compliance with international medical device quality management standards.

The SubQ It! system deploys each bioabsorbable fastener in approximately 7 seconds, compared to roughly 42 seconds per stitch with manual suturing — making it 7X faster. For a 25 cm incision using the SU-25 model, this represents a significant reduction in closure time and associated OR costs.

Choose the SU-10 for incisions up to 10 cm, such as trocar or small orthopedic incisions in minimally invasive procedures. For larger orthopedic incisions up to 25 cm, the SU-25 model with 25 bioabsorbable fasteners is recommended. Both are pre-sterilized, single-use, and sealed in foil laminate pouches.

No. Unlike traditional metal skin staplers, the SubQ It! system places fasteners subcutaneously — beneath the skin surface — so the external skin is never pierced. This eliminates the train-track scarring pattern common with percutaneous metal staples and produces superior cosmetic outcomes for patients.

The SubQ It! stapler includes a safety tab, automatic needle retraction after deployment, and a safety stop mechanism to prevent accidental firing. The two small surgical needles retract immediately after subcutaneous placement, reducing the risk of needlestick injuries for the surgical team.

Yes. Opus KSD provides in-service training videos, detailed Instructions for Use (IFU) documentation, and direct technical support for surgical teams and facilities. Distribution support and opportunities are also available for healthcare organizations interested in stocking or distributing the SubQ It! system. Contact the sales team at sales@subq-it.com.