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FDA 510(k)

KinematX Total Wrist Arthroplasty System

K-Number: K191525 · 2020-03-04

ApplicantExtremity Medical, LLC
Decision Date2020-03-04
Product CodeJWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KinematX Total Wrist Arthroplasty System is a medical device manufactured by Extremity Medical, LLC. It received FDA 510(k) clearance on 2020-03-04 under approval number K191525. The device is classified under product code JWJ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KinematX Total Wrist Arthroplasty System?

KinematX Total Wrist Arthroplasty System is a medical device that received FDA 510(k) clearance on 2020-03-04. It is manufactured by Extremity Medical, LLC. The 510(k) number is K191525.

When was KinematX Total Wrist Arthroplasty System approved by the FDA?

KinematX Total Wrist Arthroplasty System received FDA 510(k) clearance on 2020-03-04, under approval number K191525.

What company makes KinematX Total Wrist Arthroplasty System?

KinematX Total Wrist Arthroplasty System is manufactured by Extremity Medical, LLC.

What is the FDA product code for KinematX Total Wrist Arthroplasty System?

The FDA product code for KinematX Total Wrist Arthroplasty System is JWJ.

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 NCT07613203 Forced-Air Warming for Preventing Perioperative Hypothermia During Total Knee Arthroplasty COMPLETED NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT07613476 Pregabalin Phonophoresis for Carpal Tunnel Syndrome Pain ACTIVE_NOT_RECRUITING NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) 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: 40025985 Patient-reported outcome measures offer little additional value two years after arthroplasty : a systematic review and meta-analysis. The bone & joint journal (2025)

Other Devices by Extremity Medical, LLC

K160191Align Anterior Ankle Fusion Plate K172260Omni Foot Plating System K171018Axis Charcot Fixation System, 4.5 to 8.5mm Screw System K181067AlignX Ankle Fusion System K180808Omni Foot Plating System K192592Axis Plating System

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Related Devices (Code: JWJ)

K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. K243381Total Wrist Arthroplasty System (TWA)Skeletal Dynamics, Inc. K233574Total Wrist Arthroplasty System (TWA)Skeletal Dynamics K233674Freedom Wrist Arthroplasty SystemAscension Orthopedics, 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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