CoNextions Medical

Company overview

CoNextions Medical is a Salt Lake City, Utah orthopedic device company led by President and CEO Dan Gruppo. It develops implants and delivery systems for repairing tendons and fixing soft tissue to bone.

The CoNextions TR Tendon Repair System uses anchors connected by high-strength polyethylene yarn to repair lacerated or severed tendons. Coronet combines a soft-tissue washer, continuous suture loop and bone anchor for soft-tissue-to-bone fixation. The two products address different repair tasks and have separate FDA clearances.

The company’s current website lists U.S. distribution through Stryker, alongside availability in Chile, Kuwait and South Africa. Its product materials include operative techniques, instructions for use and clinical and biomechanical studies focused on tendon repair.

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Products & regulatory status How does MedTechIndex get this information?

Summary

FDA cleared Coronet under K200028 on March 4, 2020 and CoNextions TR under K203855 on April 22, 2022. These are separate Class II devices: Coronet provides soft-tissue-to-bone fixation, while TR is intended for repair of lacerated or severed tendons in the hand, wrist and forearm in adults. ^[1][2][3]

The TR FDA submission includes clinical evaluation of flexor tendon repair. The manufacturer also publishes biomechanical comparisons, but laboratory findings about repair strength, speed or gliding should not be treated as guarantees of better outcomes for every patient. ^[1][2][3]

Regulatory snapshot How to read this snapshot

U.S. FDA

2+

510(k) clearances

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De Novo grants

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PMA approvals

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Recall events

Latest recorded source review: 2026-11-06.

Scope: selected product families.

Commercial portfolio snapshot

Documented commercial product families.

Tendon repair implant and delivery system

CoNextions TR Tendon Repair System ↗

Single-use implant and delivery system using two stainless steel anchors connected by loops of ultra-high-tenacity polyethylene yarn. Designed for repair of lacerated or severed tendons in adult hands, wrists and forearms. ^[4][2]

FDA 510(k) cleared · K203855

Soft-tissue-to-bone fixation implant

Coronet Soft Tissue Fixation System ↗

Implant system combining a soft-tissue washer, continuous polyethylene suture loop and bone anchor. Its delivery system places the components to provide knotless soft-tissue-to-bone fixation. ^[5][1]

FDA 510(k) cleared · K200028