Signature ONE System— 510(k) K260104

Name: FDA 510(k) clearance K260104
Creator: U.S. Food and Drug Administration
Published: 2026-02-04

Substantially Equivalent

Orthosoft Inc. (d/b/a) Zimmer CAS

FDA 510(k) clearance K260104 for Signature ONE System, Substantially Equivalent on 2026-02-04. Applicant: Orthosoft Inc. (d/b/a) Zimmer CAS. Device class: 2.

Clearance details

Applicant: Orthosoft Inc. (d/b/a) Zimmer CAS
Product code: Code QHE
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2026-01-13
Decision date: 2026-02-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Montreal, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code QHE

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K260802 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner2026-06-09
K261510 — Signature ONE System2026-06-04
K251558 — Precision AI Surgical Planning System (PAI-SPS)2026-01-12
K243509 — Archer PSI System2025-05-12
K241470 — CORE Shoulder System2025-02-20

More clearances from Orthosoft Inc. (d/b/a) Zimmer CAS

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K260582 — ROSA® Shoulder System2026-05-21
K251314 — Rosa® Knee System2025-11-13
K242864 — ROSA® Knee System2024-10-18
K233199 — ROSA® Shoulder System2024-02-21
K232425 — Signature ONE System2023-12-12

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