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FDA 510(k)

Libertas Hip Replacement System

K-Number: K180973 · 2018-09-28

ApplicantMaxx Orthopedics, Inc.
Decision Date2018-09-28
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Libertas Hip Replacement System is a medical device manufactured by Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2018-09-28 under approval number K180973. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Libertas Hip Replacement System?

Libertas Hip Replacement System is a medical device that received FDA 510(k) clearance on 2018-09-28. It is manufactured by Maxx Orthopedics, Inc.. The 510(k) number is K180973.

When was Libertas Hip Replacement System approved by the FDA?

Libertas Hip Replacement System received FDA 510(k) clearance on 2018-09-28, under approval number K180973.

What company makes Libertas Hip Replacement System?

Libertas Hip Replacement System is manufactured by Maxx Orthopedics, Inc..

What is the FDA product code for Libertas Hip Replacement System?

The FDA product code for Libertas Hip Replacement System is JDI.

Related Clinical Trials

NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT07601269 Replacement of the Native Mitral Valve Using the ReValve System RECRUITING NCT06414265 Reduction of Mitral Regurgitation With the SATURN Trans-Septal Transcatheter Mitral Valve Replacement (TMVR) System in Patients With Severe Symptomatic Mitral Regurgitation RECRUITING NCT06608823 ARTIST: Aortic Regurgitation Trial Investigating Surgery Versus Trilogy™ RECRUITING NCT03242642 Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation. RECRUITING NCT07276711 CAPTURE-2: Controlled Arterial Protection to Ultimately Remove Embolic Material RECRUITING

Related PubMed Literature

PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Other Devices by Maxx Orthopedics, Inc.

K192148Freedom Primary PCK K183684Libertas – Taper Uncemented Femoral Stem K183365Libertas Acetabular Hooded Liner K182574Freedom Ultra-Congruent CR Tibial Liner K200912Freedom(R) - TiNbN Coated Knee K192989Libertas E-XLPE Modular Liner

View all 17 devices →

Related Devices (Code: JDI)

K160923REDAPT Anteverted Cemented LinerSmith & Nephew, Inc. K153057FitRite™ Total Hip Arthroplasty SystemExcera Orthopedics, Inc. K153725Corin TaperFit Hip StemCorin U.S.A. Limited K153216Alpine Cemented Hip SystemOrtho Development Corporation K162125MALUC™ Total Hip Arthroplasty SystemSurgtech, Inc. K191414EXETER Centralizer, EXETER 2.5mm PlugStryker 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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