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FDA 510(k)

Signature™ ONE System

K-Number: K261510 · 2026-06-04

ApplicantOrthosoft Inc. (d/b/a) Zimmer CAS
Decision Date2026-06-04
Product CodeQHE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Signature™ ONE System is the device name listed in this FDA 510(k) record. The listed applicant is Orthosoft Inc. (d/b/a) Zimmer CAS. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K261510. 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 2026-06-04. The listed applicant is Orthosoft Inc. (d/b/a) Zimmer CAS. The 510(k) number is K261510.

When did Signature™ ONE System receive FDA 510(k) clearance?

Signature™ ONE System received FDA 510(k) clearance on 2026-06-04, under 510(k) number K261510.

Who is the listed applicant for Signature™ ONE System?

The FDA 510(k) record lists Orthosoft Inc. (d/b/a) Zimmer CAS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Signature™ ONE System?

The FDA product code for Signature™ ONE System is QHE.

Other records listing Orthosoft Inc. (d/b/a) Zimmer CAS as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260582ROSA® Shoulder SystemK260104Signature™ ONE SystemK251314Rosa® Knee SystemK242864ROSA® Knee SystemK233199ROSA® Shoulder SystemK232425Signature™ ONE System

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Related Devices (Code: QHE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260802Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder PlannerMaterialise NVK260104Signature™ ONE SystemOrthosoft Inc. (d/b/a) Zimmer CASK251558Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.K243509Archer PSI System3D-SideK241470CORE Shoulder SystemLinkBio Corp.K243955Precision AI Surgical Planning System (PAI-SPS)Precision AI Pty, Ltd.

Official Source

View on FDA Database →

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

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