Cleared Traditional

K080426 - MAESTRO WRIST FRACTURE IMPLANT

K080426 is an FDA 510(k) clearance for MAESTRO WRIST FRACTURE IMPLANT, manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code JWJ cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K080426 · Biomet Manufacturing Corp · Orthopedic device
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Jul 2008
Decision
160d
Days
Class 2
Risk

K080426 is an FDA 510(k) clearance for the MAESTRO WRIST FRACTURE IMPLANT. Classified as Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (product code JWJ), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on July 29, 2008 after a review of 160 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 Biomet Manufacturing Corp devices

FDA 510(k) Submission Details - K080426

510(k) Number K080426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2008
Decision Date July 29, 2008
Days to Decision 160 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
38d slower than avg
Panel avg: 122d · This submission: 160d
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 16
Devices cleared under the same product code (JWJ) and FDA review panel - the closest regulatory comparables to K080426.
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 TOTAL WRIST
K042032 · Biomet, Inc. · Oct 2004
BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST
K031203 · DePuy Orthopaedics, Inc. · Jul 2003
UNIVERSAL TOTAL WRIST SYSTEM
K030037 · Kinetikos Medical, Inc. · Feb 2003