Cleared Traditional

K233574 - Total Wrist Arthroplasty System (TWA)

K233574 is an FDA 510(k) clearance for Total Wrist Arthroplasty System (TWA), manufactured by Skeletal Dynamics. The device is a Class 2 Orthopedic device with product code JWJ cleared through the Traditional 510(k) pathway after a 239-day FDA review.

K233574 · Skeletal Dynamics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2024
Decision
239d
Days
Class 2
Risk

K233574 is an FDA 510(k) clearance for the Total Wrist Arthroplasty System (TWA). Classified as Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (product code JWJ), Class II - Special Controls.

Submitted by Skeletal Dynamics (Miami, US). The FDA issued a Cleared decision on July 3, 2024 after a review of 239 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 Skeletal Dynamics devices

FDA 510(k) Submission Details - K233574

510(k) Number K233574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2023
Decision Date July 03, 2024
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWJ Device Classification - Class 2, Special Controls

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 12
Devices cleared under the same product code (JWJ) and FDA review panel - the closest regulatory comparables to K233574.
Total Wrist Arthroplasty System (TWA)
K243381 · Skeletal Dynamics, Inc. · Nov 2024
Freedom Wrist Arthroplasty System
K233674 · Ascension Orthopedics, Inc. · May 2024
Arthrosurface WristMotion Total Wrist Arthroplasty System
K200718 · Arthrosurface, Inc. · Oct 2020
KinematX Total Wrist Arthroplasty System
K191525 · Extremity Medical, LLC · Mar 2020
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM
K132250 · Integra LifeSciences Corporation · Mar 2014
MAESTRO WRIST FRACTURE IMPLANT
K080426 · Biomet Manufacturing Corp · Jul 2008