Cleared Traditional

K964381 - AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT

K964381 is an FDA 510(k) clearance for AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT, manufactured by Avanta Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KYI cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K964381 · Avanta Orthopaedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
79d
Days
Class 2
Risk

K964381 is an FDA 510(k) clearance for the AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT. Classified as Prosthesis, Wrist, Carpal Trapezium (product code KYI), Class II - Special Controls.

Submitted by Avanta Orthopaedics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 22, 1997 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3770 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Avanta Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K964381

510(k) Number K964381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1996
Decision Date January 22, 1997
Days to Decision 79 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
43d faster than avg
Panel avg: 122d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KYI Device Classification - Class 2, Special Controls

Product Code KYI Prosthesis, Wrist, Carpal Trapezium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3770
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 - KYI Prosthesis, Wrist, Carpal Trapezium

All 17
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K964381.
AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT
K965204 · Avanta Orthopaedics, Inc. · Jun 1997
METALLIC SPHERICAL CMC IMPLANT
K960534 · Wrightmedicaltechnologyinc · Feb 1997
CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
K960659 · Wrightmedicaltechnologyinc · Feb 1997
STRICKLAND TRAPEZIAL IMPLANT
K951471 · Wrightmedicaltechnologyinc · Aug 1995
SWANSON TITANIUM CONDYLAR IMPLANT
K864488 · Dow Corning Wright · Apr 1987
SWANSON TITANIUM TRAPEZIUM IMPLANT
K864489 · Dow Corning Wright · Apr 1987