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The PONTiSTM Nonabsorbable Ultra-High Molecular Weight Polyethylene Braided Sutures are indicated to secure soft tissue to soft tissue reattachment in the hand: - Collateral Ligaments around the PIP, DIP and MCP Joints . - . Flexor and Extensor Tendons The PONTiSTM 3mm Nonabsorbable Suture Anchors with Ultra-High Molecular Weight Polyethylene Braided Suture are indicated to secure soft tissue to bone reattachment in the hand: - Collateral Ligaments around the PIP, DIP and MCP Joints . - Flexor and Extensor Tendons ●

The PONTISTM 3mm anchor is made of 316L stainless steel and incorporates non-absorbable UHMWPe sutures which are available in United States Pharmacopoeia (USP) sizes 4-0 to 2-0 in various lengths and cleared to market under K094028. UHMWPe sutures and 316L Stainless steel are used in a wide variety of medical devices including previously approved implants of this type. The UHMWPe Sutures will be secured by knot tying. The UHMWPe sutures are supplied sterile and armed with cutting needles. A single use driver and hand piece will hold the excess suture, which delivers the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to bone. The anchor is the same as was cleared under K101126, PONTIS Sutures and Suture Anchor with Optional Crimps.