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FDA 510(k)

Freedom Infinia™ Total Knee System

K-Number: K253314 · 2025-10-29

ApplicantMaxx Orthopedics, Inc.
Decision Date2025-10-29
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Freedom Infinia™ Total Knee System is a medical device manufactured by Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2025-10-29 under approval number K253314. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Freedom Infinia™ Total Knee System?

Freedom Infinia™ Total Knee System is a medical device that received FDA 510(k) clearance on 2025-10-29. It is manufactured by Maxx Orthopedics, Inc.. The 510(k) number is K253314.

When was Freedom Infinia™ Total Knee System approved by the FDA?

Freedom Infinia™ Total Knee System received FDA 510(k) clearance on 2025-10-29, under approval number K253314.

What company makes Freedom Infinia™ Total Knee System?

Freedom Infinia™ Total Knee System is manufactured by Maxx Orthopedics, Inc..

What is the FDA product code for Freedom Infinia™ Total Knee System?

The FDA product code for Freedom Infinia™ Total Knee System is JWH.

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 NCT07607457 Development and Evaluation of the Effectiveness of Patient Gowns for Patients Undergoing Abdominal Surgery NOT_YET_RECRUITING NCT04325022 Safety and Effectiveness Study of OR3O™ Dual Mobility System in THA ACTIVE_NOT_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: JWH)

K160515PS2 Knee SystemConsensus Orthopedics, Inc. K160771Destiknee Total Knee SystemMeril Healthcare Private Limited K160157LOSPA Modular Knee SystemCorentec Co., Ltd. K162273Materialise TKA Guide SystemMaterialise NV K162422Klassic Knee SystemTotal Joint Orthopedics, Inc. K161945EXPRT Revision Knee Femoral Augment(5mm), EXPRT Revision Knee Stem Extension (40mm)Encore Medical L.P.

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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