FDA 510(k)

Signature ONE System

K-Number: K260104 · 2026-02-04

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

Decision Date2026-02-04

Product CodeQHE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Signature ONE System is a medical device manufactured by Orthosoft Inc. (d/b/a) Zimmer CAS. It received FDA 510(k) clearance on 2026-02-04 under approval number K260104. The device is classified under product code QHE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Signature ONE System?

Signature ONE System is a medical device that received FDA 510(k) clearance on 2026-02-04. It is manufactured by Orthosoft Inc. (d/b/a) Zimmer CAS. The 510(k) number is K260104.

When was Signature ONE System approved by the FDA?

Signature ONE System received FDA 510(k) clearance on 2026-02-04, under approval number K260104.

What company makes Signature ONE System?

Signature ONE System is manufactured by Orthosoft Inc. (d/b/a) Zimmer CAS.

What is the FDA product code for Signature ONE System?

The FDA product code for Signature ONE System is QHE.

Other Devices by Orthosoft Inc. (d/b/a) Zimmer CAS

K242864ROSA® Knee System K251314Rosa® Knee System

Related Devices (Code: QHE)

K192074Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K202454Smart SPACE Shoulder SystemTechmah Medical, LLC K200615Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K193560Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase PlannerMaterialise NV K212560Signature ONE SystemOrthosoft Inc (D/B/A Zimmer Cas) K202151Smart SPACE Shoulder SystemTechmah Medical, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.