ClearPoint System (Software Version 3.0)

K243657

ClearPoint Neuro, Inc. · cleared 2025-01-24 · product code HAW · Neurology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The ClearPoint System is intended to provide stereotactic guidance for the placement and operation of instruments or devices during planning and operation of neurological procedures within an operating room environment and in conjunction with MR and/or CT imaging. During planning, the system is intended to provide functionality for the automatic identification, labeling, visualization, and quantification of segmentable brain structures from a set of loaded MR images.”
AlgorithmAlgorithm to automatically identify anterior commissure (AC) and posterior commissure (PC) locations within the brain. Algorithms to automatically locate and identify marking grid, targeting frame components, cannula, and device tip from both MR and CT image sets. Automated measurement of brain tissue volumes and structures from MR images. Automatic segmentation and quantification of brain structures using proprietary shape-constrained segmentation algorithms from MR images.
source quote (p.14)
“Algorithm to automatically identify anterior commissure (AC) and posterior commissure (PC) locations within the brain. Algorithms to automatically locate and identify marking grid, targeting frame components, cannula, and device tip from both MR and CT image sets. Automated measurement of brain tissue volumes and structures from MR images. Automatic segmentation and quantification of brain structures using proprietary shape-constrained segmentation algorithms from MR images.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: Positional Error (mm); Angular Error (deg.)

Bench

sample size not stated

endpoints: Positional Error (mm); Trajectory Angle Error (Degrees)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

5
recalls in product code, 24mo
1922
MAUDE reports in code, 12mo
-39%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code HAW (Howmedica Osteonics Corp., initiated 2025-11-12): "When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an in" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97988

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243657