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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 the device name listed in this FDA 510(k) record. The listed applicant is Maxx Orthopedics, Inc.. It received FDA 510(k) clearance on 2025-10-29 under 510(k) 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. The listed applicant is Maxx Orthopedics, Inc.. The 510(k) number is K253314.

When did Freedom Infinia™ Total Knee System receive FDA 510(k) clearance?

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

Who is the listed applicant for Freedom Infinia™ Total Knee System?

The FDA 510(k) record lists Maxx Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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.

NCT06627673MultiCenter IDE Study of the PEEK-OPTIMA™ Femoral Component vs a CoCr Alloy TKA Femoral Component of Similar DesignRECRUITINGNCT06627699Prospective, In-Vivo, Post-Market Safety and Efficacy Surveillance Registry of the MAXX Orthopedics, Freedom Total Knee® SystemRECRUITING

Other records listing Maxx Orthopedics, Inc. as applicant

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)K253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)K253144Freedom® Total Knee System – Titan PCK ComponentsK243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)K251717Freedom® Total Knee System – Titanium Tibial Base Plate

View all 18 devices →

Related Devices (Code: JWH)

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.

K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UCK261032NovoKnee (SteriKnee)NovoSourceK253793Materialise TKA Guide SystemMaterialise NV

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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