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FDA 510(k)

Arthrosurface WristMotion Total Wrist Arthroplasty System

K-Number: K200718 · 2020-10-15

ApplicantArthrosurface, Inc.
Decision Date2020-10-15
Product CodeJWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrosurface WristMotion Total Wrist Arthroplasty System is a medical device manufactured by Arthrosurface, Inc.. It received FDA 510(k) clearance on 2020-10-15 under approval number K200718. 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 Arthrosurface WristMotion Total Wrist Arthroplasty System?

Arthrosurface WristMotion Total Wrist Arthroplasty System is a medical device that received FDA 510(k) clearance on 2020-10-15. It is manufactured by Arthrosurface, Inc.. The 510(k) number is K200718.

When was Arthrosurface WristMotion Total Wrist Arthroplasty System approved by the FDA?

Arthrosurface WristMotion Total Wrist Arthroplasty System received FDA 510(k) clearance on 2020-10-15, under approval number K200718.

What company makes Arthrosurface WristMotion Total Wrist Arthroplasty System?

Arthrosurface WristMotion Total Wrist Arthroplasty System is manufactured by Arthrosurface, Inc..

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

The FDA product code for Arthrosurface WristMotion 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 Arthrosurface, Inc.

K161539Arthrosurface Bone Screws K152454HemiCAP MTP Resurfacing Hemi-Arthroplasty System K172383Arthrosurface Bone Screws K170440KISSloc Suture System K170350ToeMATE® Hammertoe Correction System K162391AlignMATE™ Lapidus Arthrodesis System

View all 11 devices →

Related Devices (Code: JWJ)

K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC 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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