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FDA 510(k)

RECLAIM Monobloc Revision Femoral Stem

K-Number: K251292 · 2025-05-23

ApplicantDepuy Ireland UC
Decision Date2025-05-23
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RECLAIM Monobloc Revision Femoral Stem is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Ireland UC. It received FDA 510(k) clearance on 2025-05-23 under 510(k) number K251292. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECLAIM Monobloc Revision Femoral Stem?

RECLAIM Monobloc Revision Femoral Stem is a medical device that received FDA 510(k) clearance on 2025-05-23. The listed applicant is Depuy Ireland UC. The 510(k) number is K251292.

When did RECLAIM Monobloc Revision Femoral Stem receive FDA 510(k) clearance?

RECLAIM Monobloc Revision Femoral Stem received FDA 510(k) clearance on 2025-05-23, under 510(k) number K251292.

Who is the listed applicant for RECLAIM Monobloc Revision Femoral Stem?

The FDA 510(k) record lists Depuy Ireland UC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RECLAIM Monobloc Revision Femoral Stem?

The FDA product code for RECLAIM Monobloc Revision Femoral Stem is LZO.

Other records listing Depuy Ireland UC as applicant

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Related Devices (Code: LZO)

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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, Inc.

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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