Cleared Traditional

K021859 - WRIST IMPLANT

K021859 is an FDA 510(k) clearance for WRIST IMPLANT, manufactured by Avanta Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code JWJ cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K021859 · Avanta Orthopaedics, Inc. · Orthopedic device
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Dec 2002
Decision
179d
Days
Class 2
Risk

K021859 is an FDA 510(k) clearance for the WRIST IMPLANT. Classified as Prosthesis, Wrist, 3 Part Metal-plastic-metal Articulation, Semi-constrained (product code JWJ), Class II - Special Controls.

Submitted by Avanta Orthopaedics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 2, 2002 after a review of 179 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 Avanta Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K021859

510(k) Number K021859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 2002
Decision Date December 02, 2002
Days to Decision 179 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
57d slower than avg
Panel avg: 122d · This submission: 179d
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 K021859.
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
MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM
K020554 · Kinetikos Medical, Inc. · May 2002
PASCO MIC AND MIC/ID PANELS/ CEFDINIR
K982156 · Pasco Laboratories, Inc. · Jul 1998
UNIVERSAL TOTAL WRIST SYSTEM (MODIFICATION)
K961051 · Kinetikos Medical, Inc. · Jun 1996