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FDA 510(k)

Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement

K-Number: K260536 · 2026-05-15

ApplicantDepuy Ireland UC
Decision Date2026-05-15
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement 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 2026-05-15 under 510(k) number K260536. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement?

Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement is a medical device that received FDA 510(k) clearance on 2026-05-15. The listed applicant is Depuy Ireland UC. The 510(k) number is K260536.

When did Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement receive FDA 510(k) clearance?

Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement received FDA 510(k) clearance on 2026-05-15, under 510(k) number K260536.

Who is the listed applicant for Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement?

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 Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement?

The FDA product code for Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement is KWL.

Related Clinical Trials

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.

NCT04251377Single-stage Surgery With Antibiotic-loaded Hydrogel Coated Implants Versus Two Stage Surgery for Secondary Prevention of Complex Chronic Periprosthetic Hip Joint InfectionACTIVE_NOT_RECRUITINGNCT06293352Real-component vs All-cement Articulating Spacers for Periprosthetic Knee InfectionRECRUITING

Other records listing Depuy Ireland UC as applicant

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K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemK260480VELYS™ Robotic-Assisted SolutionK253624INHANCE™ Reverse Shoulder SystemK253551VELYS™ Hip NavigationK253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsK251292RECLAIM Monobloc Revision Femoral Stem

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Related Devices (Code: KWL)

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.

K262290REMEDY POLY+PLUS SNAP FIT Acetabular CupOsteoremedies, LLCK253675OsteoRemedies Hip Spacer SystemOsteoremedies, LLCK252326InterSpace GV Hip SpacerTecres S.P.A.K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerBiocomposites, Ltd.K234028COPAL® exchange G hip spacer; COPAL® G+VHeraeus Medical GmbHK222632UHR Bipolar Implants, Restoration GAP II ImplantsHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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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