Cleared Traditional

KinematX Total Wrist Arthroplasty System (K191525) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K191525 · Extremity Medical, LLC · Orthopedic device
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Mar 2020
Decision
268d
Days
Class 2
Risk

K191525 is an FDA 510(k) clearance for the KinematX Total Wrist Arthroplasty System. Classified as Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (product code JWJ), Class II - Special Controls.

Submitted by Extremity Medical, LLC (Parsippany, US). The FDA issued a Cleared decision on March 4, 2020 after a review of 268 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3800 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Extremity Medical, LLC devices

Submission Details

510(k) Number K191525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2019
Decision Date March 04, 2020
Days to Decision 268 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
146d slower than avg
Panel avg: 122d · This submission: 268d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWJ Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JWJ Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained

All 16
Devices cleared under the same product code (JWJ) and FDA review panel - the closest regulatory comparables to K191525.
Total Wrist Arthroplasty System (TWA)
K243381 · Skeletal Dynamics, Inc. · Nov 2024
Total Wrist Arthroplasty System (TWA)
K233574 · Skeletal Dynamics · Jul 2024
Freedom Wrist Arthroplasty System
K233674 · Ascension Orthopedics, Inc. · May 2024
Arthrosurface WristMotion Total Wrist Arthroplasty System
K200718 · Arthrosurface, Inc. · Oct 2020
MAESTRO TOTAL WRIST
K042032 · Biomet, Inc. · Oct 2004
HAMAS PRECENTERED TOTAL WRIST
K792650 · Zimmer, Inc. · Jan 1980