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FDA 510(k)

Freedom® Total Knee System - Porous Tibial Base Plate

K-Number: K241597 · 2025-02-13

ApplicantMaxx Orthopedics, Inc.
Decision Date2025-02-13
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Freedom® Total Knee System - Porous Tibial Base Plate is a medical device manufactured by Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2025-02-13 under approval number K241597. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Freedom® Total Knee System - Porous Tibial Base Plate?

Freedom® Total Knee System - Porous Tibial Base Plate is a medical device that received FDA 510(k) clearance on 2025-02-13. It is manufactured by Maxx Orthopedics, Inc.. The 510(k) number is K241597.

When was Freedom® Total Knee System - Porous Tibial Base Plate approved by the FDA?

Freedom® Total Knee System - Porous Tibial Base Plate received FDA 510(k) clearance on 2025-02-13, under approval number K241597.

What company makes Freedom® Total Knee System - Porous Tibial Base Plate?

Freedom® Total Knee System - Porous Tibial Base Plate is manufactured by Maxx Orthopedics, Inc..

What is the FDA product code for Freedom® Total Knee System - Porous Tibial Base Plate?

The FDA product code for Freedom® Total Knee System - Porous Tibial Base Plate is MBH.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05391828 Persona MC vs PS RCT With ROSA RECRUITING NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Maxx Orthopedics, Inc.

K180973Libertas Hip Replacement System K192148Freedom Primary PCK K183684Libertas – Taper Uncemented Femoral Stem K183365Libertas Acetabular Hooded Liner K182574Freedom Ultra-Congruent CR Tibial Liner K200912Freedom(R) - TiNbN Coated Knee

View all 17 devices →

Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, 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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