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FDA 510(k)

Total Wrist Arthroplasty System (TWA)

K-Number: K243381 · 2024-11-01

ApplicantSkeletal Dynamics, Inc.
Decision Date2024-11-01
Product CodeJWJ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Total Wrist Arthroplasty System (TWA) is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2024-11-01 under approval number K243381. 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 Total Wrist Arthroplasty System (TWA)?

Total Wrist Arthroplasty System (TWA) is a medical device that received FDA 510(k) clearance on 2024-11-01. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K243381.

When was Total Wrist Arthroplasty System (TWA) approved by the FDA?

Total Wrist Arthroplasty System (TWA) received FDA 510(k) clearance on 2024-11-01, under approval number K243381.

What company makes Total Wrist Arthroplasty System (TWA)?

Total Wrist Arthroplasty System (TWA) is manufactured by Skeletal Dynamics, Inc..

What is the FDA product code for Total Wrist Arthroplasty System (TWA)?

The FDA product code for Total Wrist Arthroplasty System (TWA) 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 Skeletal Dynamics, Inc.

K201962Skeletal Dynamics Ulnar Shortening Plating System K201662REDUCT® Headless Compression Screw System K200538Skeletal Dynamics Forearm Plating System K200701Skeletal Dynamics Midshaft Humerus Plating System K200367Distal Humerus Plating System K211439Small Bone Nailing System

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Related Devices (Code: JWJ)

K200718Arthrosurface WristMotion Total Wrist Arthroplasty SystemArthrosurface, Inc. K191525KinematX Total Wrist Arthroplasty SystemExtremity Medical, LLC 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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