Acorn 3D Software

The original segmentation metrics and test exclusions were confirmed. They remain attributed to K252103, not relabeled as new Correction-module performance. Automatic segmentation scope is T1–T12, L1–L5 and sacrum; manual and semi-automatic tools have a broader scope.

The new dossier reports bench testing of simulated corrections against surgeon-defined inputs, with target angular metrics within 3°. It does not establish better surgical or patient outcomes. The summary states that there have been no algorithm improvements since K252103 and no changes to the inherited PCCP. The decision letter includes PCCP language while the database field says No; these sources are not fully aligned, so this record does not claim a newly authorized PCCP. Expert clinical judgment remains required.

FDA K260322 decision and summary (PDF) · Later FDA database record

FDA database record K252103 · Decision Dec 2, 2025.

Source locations: K252103 PDF pp. 13–14 (summary pp. 9–10); K260322 PDF pp. 4–7, 12–13.

No matching recall was returned by the identifier query. Recall queries used the listed 510(k) identifiers and product/manufacturer names. The retrieved openFDA recall dataset was last updated September 3, 2026. A missing match does not establish that a device is free of recalls, adverse events, or risk; reporting and indexing can lag.

No product-matched patient-outcome study published August 17–September 6, 2026 was verified in this targeted search. This is a search result, not proof that no new evidence exists. Older or differently named systems and company announcements were not treated as evidence of benefit for the listed version.

Targeted check of FDA decision records, cited summary sections, device-linked recall records, and indexed clinical literature. This is not a systematic review or continuous safety surveillance. Next planned safety scan: Oct 6, 2026. This check does not reset the original summary-review date.