Ossentra

Craniosynostosis · SickKids

Robotics for the smallest skulls.

The first articulating, robot-ready bone-cutting instrument for minimally invasive pediatric skull surgery.

How it worksWhy it matters

Investigational device. Bench-stage prototype, not cleared for clinical use. Advancing toward FDA Class II 510(k).

Ossentra articulating instrument following the curved endoscopic path beneath the scalp
A steerable instrument for curved osteotomy trajectories.

Open surgery vs. Ossentra

Blood transfusion rate
83→10%
Open versus endoscopic, life-altering for a 3-month-old
Less OR time per case
40–50%
Open surgery cut to 1.5–2 hours
Saved per converted case
$80K
Open ~$120K vs. endoscopic ~$40K
ICU stay
3→1day
Recovery within the 3–6-month window

The instrument

Others cut bone. Others articulate. We do both.

Tools that cut bone are rigid and straight. Tools that bend are made for soft tissue. No instrument has done both, until now.

3 sliding curved joints

Articulate

Follows the curved endoscopic path along the infant cranium.

Punch · Burr · Ultrasonic

Cuts bone

Interchangeable tips: bone punch, burr, ultrasonic cutter.

⌀ 13 mm shaft

Right scale

Purpose-built for the 3–6-month infant skull.

Technology

Competition

Others cut bone. Others articulate. We do both.

Bone cutters are straight. Articulating tools are for soft tissue. The closest thing, JPI's bur, is built for adult joints. Ossentra is the only device that does all five.

Competitive comparison: Ossentra vs. bone cutters, articulating tools, and robots
Cuts bone × articulates × infant scale × endoscopic access × cleared. Ossentra satisfies all five.
How it works

Development status

Where the programme is.

Each stage gates the next. Nothing skipped, nothing finished early.

  1. 01

    Handheld prototype, published

    Cable-driven bending section, integrated end-effector, flexible endoscope. ASME J. Medical Devices, 2025.

    complete
  2. 02

    Bench characterization

    Stiffness, cutting force, and workspace on CT-derived skull phantoms.

    complete
  3. 03

    Surgeon evaluation

    TIAP study of 10 US surgeons. Half would trial it, and articulation was the feature they valued most.

    complete
  4. 04

    Powered cutting, suction-irrigation

    Adding the functions surgeons need for a real osteotomy: 12–18 months to 510(k) filing.

    in progress
  5. 05

    Phantom & porcine testing

    Osteotomies compared against open and endoscopic technique.

    planned
  6. 06

    FDA 510(k), Class II

    Predicate-based clearance; CE Mark and Health Canada filed in parallel.

    planned
Global craniosynostosis market today, ~$850M by 2031
$570M
Global craniosynostosis market today, ~$850M by 2031
Growth in US endoscopic procedures, 2012–2024
+195%
Growth in US endoscopic procedures, 2012–2024
FDA 510(k), predicate-based pathway
Class II
FDA 510(k), predicate-based pathway
Get in touch

We want surgeons who'll tell us it doesn't work.

Bench and cadaveric evaluation is open to craniofacial and pediatric neurosurgeons. Procurement and investor materials on request.

Contact Ossentra