Sky Surgical

Company overview

Sky Surgical is a medical device manufacturer based in Sandpoint, Idaho. Foot and ankle surgeons Jonathan Fisher and Andrew Lundquist co-founded the company in 2015 to develop implants, instruments and surgical approaches for foot surgery.

Its SkyOPS Orthopedic Plate System includes medial bunion, dorsal bunion and hallux limitus plate configurations, alongside locking and non-locking screws and associated instruments. The company combines surgeon input and biomechanical engineering to develop an integrated sequence of surgical instruments and fixation components.

Sky Surgical’s commercial emphasis is correction around the great toe through joint-preserving osteotomies. The SkyOPS system’s FDA-cleared uses also include stabilization and repair of fractures and fusions in small bones of the foot.

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Products & regulatory status How does MedTechIndex get this information?

Summary

FDA cleared the SkyOPS Orthopedic Plate System under K233154 on December 21, 2023. It is indicated to stabilize and aid in repair of fractures, fusions and osteotomies of small bones and bone fragments of the foot, in adults and pediatric patients older than 12 years. ^[1]

Sky Surgical emphasizes joint-preserving osteotomy procedures in its commercial materials. The system’s cleared indication is broader and also includes fusion and fracture repair; the medial bunion, dorsal bunion and hallux limitus plates are configurations within the SkyOPS system. ^[7][6][1]

Regulatory snapshot How to read this snapshot

U.S. FDA

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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: 2026-11-01.

Commercial portfolio snapshot

Documented commercial product families.

Foot fixation implants and surgical instruments

SkyOPS orthopedic plate and instrument system ↗

Integrated foot fixation system with medial bunion, dorsal bunion and hallux limitus plates, locking and non-locking screws, and associated surgical instruments. Plates are offered in right and left configurations. Titanium-alloy implant components and 2.4mm screws support fixation for small-bone procedures, including osteotomy correction around the great toe. ^[4][7][6][1]

Commercially available · FDA-cleared plate system