KinematX Total Wrist Arthroplasty System— 510(k) K191525

Name: FDA 510(k) clearance K191525
Creator: U.S. Food and Drug Administration
Published: 2020-03-04

Substantially Equivalent

Extremity Medical, LLC

FDA 510(k) clearance K191525 for KinematX Total Wrist Arthroplasty System, Substantially Equivalent on 2020-03-04. Applicant: Extremity Medical, LLC. Device class: 2.

Clearance details

Applicant: Extremity Medical, LLC
Product code: Code JWJ
Device class: Class 2
Regulation: 21 CFR 888.3800
Advisory panel: Orthopedic
Date received: 2019-06-10
Decision date: 2020-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JWJ

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K243381 — Total Wrist Arthroplasty System (TWA)2024-11-01
K233574 — Total Wrist Arthroplasty System (TWA)2024-07-03
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K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System2020-10-15
K132250 — INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM2014-03-24

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Adverse events under product code JWJ

product code JWJ

Injury: 181
Total: 181

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.