FDA 510(k)

OrthoGrid Hip AI® 4.0

K-Number: K260077 · 2026-05-29

Decision Date2026-05-29

Product CodeQIH

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

OrthoGrid Hip AI® 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is OrthoGrid Systems, Inc.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K260077. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OrthoGrid Hip AI® 4.0?

OrthoGrid Hip AI® 4.0 is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is OrthoGrid Systems, Inc.. The 510(k) number is K260077.

When did OrthoGrid Hip AI® 4.0 receive FDA 510(k) clearance?

OrthoGrid Hip AI® 4.0 received FDA 510(k) clearance on 2026-05-29, under 510(k) number K260077.

Who is the listed applicant for OrthoGrid Hip AI® 4.0?

The FDA 510(k) record lists OrthoGrid Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrthoGrid Hip AI® 4.0?

The FDA product code for OrthoGrid Hip AI® 4.0 is QIH.

Other records listing OrthoGrid Systems, Inc. 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.

K210136PhantomMSK Hip K192279PhantomMSK Trauma K182332PhantomMSK

Related Devices (Code: QIH)

K260811Heartvue.ProtonHeartvue.ai, Inc.K261595Ceevra Reveal 4Ceevra, Inc.K262127DS Core CBCT AnatomyDentsply Sirona K260584BoneMRIMriguidance B.V.K261641Lower Limb AI (LLAI)AI Planning Logic, Inc.K253794Prostate CoreLucida Medical, 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.