Cleared Traditional

K951471 - STRICKLAND TRAPEZIAL IMPLANT

K951471 is the FDA 510(k) clearance for STRICKLAND TRAPEZIAL IMPLANT by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code KYI) cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K951471 · Wrightmedicaltechnologyinc · Orthopedic device
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Aug 1995
Decision
132d
Days
Class 2
Risk

K951471 is an FDA 510(k) clearance for the STRICKLAND TRAPEZIAL IMPLANT. Classified as Prosthesis, Wrist, Carpal Trapezium (product code KYI), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on August 9, 1995 after a review of 132 days - within the typical 510(k) review window.

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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K951471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1995
Decision Date August 09, 1995
Days to Decision 132 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
10d slower than avg
Panel avg: 122d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K951471.
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
SWANSON TITANIUM CONDYLAR IMPLANT
K864488 · Dow Corning Wright · Apr 1987
SWANSON TITANIUM TRAPEZIUM IMPLANT
K864489 · Dow Corning Wright · Apr 1987
SILASTIC H.P. TRAPEXIAL IMPLANT
K781756 · Dow Corning Corp. Healthcare Industries Materials · Nov 1978