2D Hip Planning Software— 510(k) K261352

Name: FDA 510(k) clearance K261352
Creator: U.S. Food and Drug Administration
Published: 2026-06-08

Substantially Equivalent

One Ortho

FDA 510(k) clearance K261352 for 2D Hip Planning Software, Substantially Equivalent on 2026-06-08. Applicant: One Ortho. Device class: 2.

Summary

One Ortho's 2D Hip Planning Software is filed under LLZ, radiological image processing systems. The record doesn't describe the software beyond its name and the code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel. It was a Traditional 510(k).

One Ortho filed from Saint-Genis-Laval, France. The decision came 45 calendar days after receipt (April 24 to June 8, 2026).

Clearance details

Applicant: One Ortho
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2026-04-24
Decision date: 2026-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint-Genis-Laval, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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K263048 — Syngo Carbon Space (VA4)2026-09-29
K261874 — Syneris PACS v.1.0.1.02026-09-23
K262442 — HipStudio Analysis2026-09-22
K261855 — Elucid PlaqueIQ2026-09-18
K254214 — OOOPDS2026-09-15

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.