Cleared Traditional

K965204 - AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT

K965204 is an FDA 510(k) clearance for AVANTA ORTHOPAEDICS TRAPEZIUM 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 159-day FDA review.

K965204 · Avanta Orthopaedics, Inc. · Orthopedic device
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Jun 1997
Decision
159d
Days
Class 2
Risk

K965204 is an FDA 510(k) clearance for the AVANTA ORTHOPAEDICS TRAPEZIUM 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 June 3, 1997 after a review of 159 days - an extended review 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: 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 - K965204

510(k) Number K965204 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received December 26, 1996
Decision Date June 03, 1997
Days to Decision 159 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 122d · This submission: 159d
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 K965204.
ASCENSION PYROSPHERE (PCS)
K042690 · Ascension Orthopedics, Inc. · Nov 2004
ASCENSION PYROHEMISPHERE, MODELS PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50
K041451 · Ascension Orthopedics, Inc. · Aug 2004
TIE-IN TRAPEZIUM
K033529 · Wrightmedicaltechnologyinc · Dec 2003
METALLIC SPHERICAL CMC IMPLANT
K960534 · Wrightmedicaltechnologyinc · Feb 1997
CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)
K960659 · Wrightmedicaltechnologyinc · Feb 1997
AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT
K964381 · Avanta Orthopaedics, Inc. · Jan 1997