Active-V Total Knee System; World Total Knee System
K-Number: K253239 · 2025-12-23
ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2025-12-23
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Active-V Total Knee System; World Total Knee System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2025-12-23 under approval number K253239. 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 Active-V Total Knee System; World Total Knee System?
Active-V Total Knee System; World Total Knee System is a medical device that received FDA 510(k) clearance on 2025-12-23. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K253239.
When was Active-V Total Knee System; World Total Knee System approved by the FDA?
Active-V Total Knee System; World Total Knee System received FDA 510(k) clearance on 2025-12-23, under approval number K253239.
What company makes Active-V Total Knee System; World Total Knee System?
Active-V Total Knee System; World Total Knee System is manufactured by Signature Orthopaedics Pty, Ltd..
What is the FDA product code for Active-V Total Knee System; World Total Knee System?
The FDA product code for Active-V Total Knee System; World Total Knee System 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
NCT06762717
FARAPULSE™ Pulsed Field Ablation System
RECRUITING
NCT06420323
NovoX®Cup as Primary Dressing After Breast Reduction
ACTIVE_NOT_RECRUITING
NCT07614373
Virtual Reality-based Mindfulness Training for Mental Health After Stroke
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)
PMID: 41839575
A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement.
International journal of spine surgery (2026)
PMID: 41734979
Strategies to Increase Patients' Adherence to Digital Therapeutics for Musculoskeletal Diseases: A Narrative Review.
Yonsei medical journal (2026)
PMID: 40948288
[Research on Application of Medical Device Real-World Evidence in Regulatory Decisions of the United States].
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)
Other Devices by Signature Orthopaedics Pty, Ltd.
K160159Active-X Total Knee System
K161155Origin Coxa Vara Hip Stem
K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular Liner
K172019Brisbane ALIF Device, Gladstone ALIF Device
K172020Arlington PLIF/TLIF Cage
K163625NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System
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.