BETA
Swiss spine-surgery company combining fixation and fusion implants, surgical access tools, and augmented-reality rod-planning software.
Neo Medical develops and commercializes technologies for spine surgery. Founded in 2013 and based in Bourg-en-Lavaux, Switzerland, the company serves European and U.S. markets. Its Neo Universal platform combines spinal fixation, interbody cages, surgical access and intraoperative software.
The company announced a Gyrus-led equity investment of up to US$68 million in September 2024, including conversion of shareholder loans, with U.S. expansion among its stated priorities. In July 2026, it announced U.S. commercial availability of Neo Instant MIS Access for posterior minimally invasive procedures.
Clinical evidence includes a published observational post-market study of Force Control fixation. That evidence, FDA marketing authorizations and manufacturer performance claims should be assessed separately; neither clearance nor commercial availability establishes comparative clinical superiority.
Fixation, cage and ADVISE records are Class II 510(k) clearances. The ADVISE applicant is Comerge AG. Exact regulatory mapping for Instant MIS Access remains unresolved; no clearance is inferred from its launch or broad platform marketing claims. A product-specific authorization for Instant MIS Access was not established. [22][25][26][5][7][21][19][1]
No matching FDA recall event was identified in the completed company/applicant, linked-identifier and product-name searches. [14][10]
Latest recorded source review: 2026-10-20.
Documented commercial product families.
Posterior spinal fixation family with screws, rods and force-control instrumentation; includes labeled use with BonOs Inject cement. [22][26]
FDA-clearedMarketed in the U.S. and Europe; exact indications and configurations depend on labeling.
Titanium interbody cage family used in spinal fusion. Current catalog availability does not establish that every historical model remains marketed. [22]
FDA-clearedCurrent platform lists interbody cages; regional availability and configuration require confirmation.
iPad-based augmented-reality tool that estimates screw relationships and supports rod selection and manual contouring when used with the NEO Pedicle Screw System. [22][25]
FDA-clearedIncluded in Neo's current platform; FDA-cleared software filed by Comerge AG.
Sterile-ready access platform for posterior minimally invasive spine procedures. [22][23]
Marketed ยท regulatory scope variesU.S. commercial launch announced July 6, 2026; international rollout described separately.
Recent work includes the U.S. MIS access rollout and continued development of the integrated spine platform. No complete, separately verified investigational pipeline was established. [23][24]
Neo announced U.S. commercial availability of its posterior minimally invasive access platform. Its release names collaborating surgeons, including Robert Eastlack of Scripps Clinic; this does not establish a system-wide procurement agreement or installed base. [23]
A 75-patient, literature-controlled observational study reported one-year screw loosening of 2.7% and functional outcomes. It was not a randomized head-to-head trial; clinical interpretation and full-text review remain pending. [20][24]
K243693 covers modifications and extensions to the existing NEO Pedicle Screw System. [26]
Gyrus-led financing of up to US$68 million (CHF58 million), including conversion of existing shareholder loans, was announced to support expansion, particularly in the U.S. This is an announced financing amount, not revenue or an independently verified lifetime funding total. [16]
FDA cleared the software under K230195, with Comerge AG as applicant, for rod-planning support with the NEO Pedicle Screw System. [33]
Accessed 10/29/2026