FDA 510(k)

DePuy Reclaim Monobloc Revision Femoral Stem

K-Number: K221462 · 2022-10-21

Decision Date2022-10-21

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

DePuy Reclaim Monobloc Revision Femoral Stem is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2022-10-21 under approval number K221462. 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 DePuy Reclaim Monobloc Revision Femoral Stem?

DePuy Reclaim Monobloc Revision Femoral Stem is a medical device that received FDA 510(k) clearance on 2022-10-21. It is manufactured by Depuy Ireland UC. The 510(k) number is K221462.

When was DePuy Reclaim Monobloc Revision Femoral Stem approved by the FDA?

DePuy Reclaim Monobloc Revision Femoral Stem received FDA 510(k) clearance on 2022-10-21, under approval number K221462.

What company makes DePuy Reclaim Monobloc Revision Femoral Stem?

DePuy Reclaim Monobloc Revision Femoral Stem is manufactured by Depuy Ireland UC.

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

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

Related Clinical Trials

NCT03153449 ATTUNE® Revision- Complex Primary in Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT03153475 ATTUNE Revision System in the Revision Total Knee Arthroplasty Population ACTIVE_NOT_RECRUITING NCT07571408 Intraoperative Application of Cold Atmospheric Plasma to Prevent Postoperative Wound Complications in the Inguinal Region of High-risk Patients With Peripheral Arterial Occlusive Disease NOT_YET_RECRUITING NCT04090359 Dual Mobility Acetabular Cups in Revision TJA RECRUITING

Other Devices by Depuy Ireland UC

K170748GLOBAL UNITE Platform Shoulder System K202248Attune Revision Sleeve LPS Femoral Adaptors K202194ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM 3DP Technology K202098GLOBAL UNITE Platform Shoulder System K200854DePuy PINNACLE Dual Mobility Liner K193549SIGMA High Performance (HP) Partial Knee System

View all 48 devices →

Related Devices (Code: LZO)

K160895Initia Total Hip System & BIOCERAM AZUL(R) HEADKyocera Medical Corporation K161830Zimmer M/L Taper Hip ProsthesisZimmer, Inc. K161192Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® SystemZimmer GmbH K152893Corin Optimized Positioning System (OPS)Corin USA K160289MasterLoc StemMedacta International K152903REVIVAL(TM) Modular Revision Hip StemCorin USA

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.