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FDA 510(k)

TriVerse Total Knee Replacement System

K-Number: K222380 · 2022-10-04

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2022-10-04
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TriVerse Total Knee Replacement System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2022-10-04 under approval number K222380. 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 TriVerse Total Knee Replacement System?

TriVerse Total Knee Replacement System is a medical device that received FDA 510(k) clearance on 2022-10-04. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K222380.

When was TriVerse Total Knee Replacement System approved by the FDA?

TriVerse Total Knee Replacement System received FDA 510(k) clearance on 2022-10-04, under approval number K222380.

What company makes TriVerse Total Knee Replacement System?

TriVerse Total Knee Replacement System is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for TriVerse Total Knee Replacement System?

The FDA product code for TriVerse Total Knee Replacement 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 NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study 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) 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: 41460256 Benchmarking THA Implant Combinations Using Data From a US Total Joint Replacement Registry. Clinical orthopaedics and related research (2026)

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

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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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