BETA
Massachusetts medical device manufacturer commercializing Ortho EDG, a sterile, single-use electronic depth gauge for orthopedic procedures.
EDGE Surgical is a medical device manufacturer based in Burlington, Massachusetts and founded in 2015. Led by CEO Leo Carayannopoulos, it develops and commercializes single-use digital instruments for orthopedic surgery.
Its Ortho EDG electronic depth gauge measures the depth of a drilled bone hole to help surgeons choose screw length. The instrument combines a digital readout with a measurement probe and hook. Its sterile, single-use format provides a fresh instrument for each procedure.
The company’s universal depth-gauge configuration uses calibration technology designed for use across major orthopedic plating systems. EDGE sells through a growing distributor network, including a documented BioIntegris agreement covering select hospitals in greater Cincinnati.
FDA cleared the Eidosmed electronic depth gauge under K091992 on December 9, 2009. The device measures the depth of a passageway in bone or other tissue to help select appropriately sized screws and implants. The original applicant was Eidosmed LLC; EDGE Surgical’s current Ortho 65mm device record explicitly identifies K091992 as its premarket submission. [6][9][7]
Latest recorded source review: 2026-11-01.
Documented commercial product families.
Sterile, disposable electronic depth gauge for measuring bone-hole depth and selecting screw length in orthopedic procedures. A sliding measurement probe and hook work with a digital display. The universal configuration incorporates dynamic calibration for use with different plating systems. [1][3][6][7][9]
Commercially available · electronic depth gaugePublicly documented relationships; coverage may be incomplete.
| Partner | Territory / scope | Products |
|---|---|---|
| BioIntegris [8] | Greater Cincinnati, Ohio · select hospitals | Ortho EDG Universal Electronic Depth Gauge |
Sources checked November 1, 2026.
EDGE named BioIntegris as an authorized distributor of Ortho EDG for select hospitals in greater Cincinnati. [8]
EDGE announced funding to support commercial expansion, restructure debt and introduce additional Ortho EDG sizes. [4]
Accessed 11/01/2026
Last substantive review: 11/1/2026