Surgery and procedural intelligence
Caresyntax
Surgical intelligence platform for connecting OR data, video, devices, workflow analytics, and quality-improvement programs.
Last updated: June 5, 2026
Back to directoryPathKeeper System medical AI product profile
FDA-cleared spine surgery navigation system using 3D optical technology, AI, and preoperative CT registration to support pedicle-screw placement.
Surgery and procedural intelligence
Best fit
Spine programs evaluating a portable navigation workflow that reduces intraoperative imaging dependence while preserving surgeon-controlled planning, registration, and instrument guidance.
- Primary use case
- AI-driven 3D optical spine navigation, preoperative CT-based planning, intraoperative registration, instrument tracking, and radiation-free pedicle-screw guidance workflow
- Audience
- Spine surgeons, orthopedic and neurosurgical teams, ambulatory surgery centers, hospital OR leaders, biomedical engineering, and surgical navigation governance committees
- Risk level
- High
- Pricing signal
- Commercial device pricing is not public; verify PathKeeper hardware, software version, service, training, support, and regional availability.
- Official sources
- 4 official sources
Compare within workflow: Surgery and procedural intelligence · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating PathKeeper System as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as high-risk surgical navigation and verify K222355, software version, labeling, geography, procedure eligibility, accessory setup, and hospital medical-device governance before clinical use. |
|---|---|
| Privacy | Review preoperative CT handling, optical 3D images, workstation data transfer, system logs, support access, cybersecurity controls, retention, website/contact-data terms, and whether any case data leaves the hospital environment. |
| Evidence | Validate registration, instrument-tracking accuracy, setup burden, radiation-reduction claims, screw-placement workflow, false reassurance risk, and discrepancy handling against local spine cases before wider rollout. |
| Workflow | Best governed as surgeon-controlled spine navigation with biomedical engineering oversight, trained setup staff, registration confirmation, standard-imaging fallback, and post-deployment monitoring of accuracy and workflow impact. |
Where PathKeeper System fits
PathKeeper describes the PathKeeper Full Spine Navigation System as an FDA-cleared medical device using AI-driven 3D optical navigation, preoperative CT planning, automated registration, real-time instrument tracking, and radiation-free intraoperative workflow. FDA 510(k) K222355 lists the PathKeeper System as a stereotaxic image-guidance system for posterior approach open spine fusion surgery during pedicle screw placement in the thoraco-lumbo-sacral region when preoperative CT imagery is available.
Not for: Autonomous surgery, unsupported spine procedures, use without preoperative CT, use outside cleared labeling, or replacing surgeon confirmation of anatomy and trajectory.
What to verify before using PathKeeper System
- Current 510(k) record, indications for use, software version, supported spinal region, procedure type, and whether the planned case matches posterior approach open spine fusion labeling.
- How preoperative CT data, optical topographic images, registration outputs, instrument tracking, system logs, and surgeon interactions are stored, transferred, retained, and secured.
- Whether registration accuracy, tool calibration, dynamic reference frame placement, surface scan quality, and refresh workflows hold up with local anatomy, OR lighting, staff setup, and surgeon technique.
- Training, credentialing, failure modes, sterile setup, fallback to standard navigation or imaging, post-case discrepancy review, and responsibility for responding to inaccurate registration.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- www.path-keeper.com
- www.path-keeper.com / pktechnology
- www.path-keeper.com / privacypolicy
- www.accessdata.fda.gov / cdrh_docs / pdf22
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