Cleared Traditional

K960659 - CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL)

K960659 is an FDA 510(k) clearance for CERAMIC SPHERICAL CMC IMPLANT (SUBJECT ..., manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code KYI cleared through the Traditional 510(k) pathway after a 356-day FDA review.

K960659 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1997
Decision
356d
Days
Class 2
Risk

K960659 is an FDA 510(k) clearance for the CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL). 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 February 6, 1997 after a review of 356 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K960659

510(k) Number K960659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 1996
Decision Date February 06, 1997
Days to Decision 356 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
234d slower than avg
Panel avg: 122d · This submission: 356d
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 22
Devices cleared under the same product code (KYI) and FDA review panel - the closest regulatory comparables to K960659.
TIE-IN TRAPEZIUM
K033529 · Wrightmedicaltechnologyinc · Dec 2003
AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT
K965204 · Avanta Orthopaedics, Inc. · Jun 1997
METALLIC SPHERICAL CMC IMPLANT
K960534 · Wrightmedicaltechnologyinc · Feb 1997
RIOPRO COBALT TRAPEZIOMETARCARPAL RESURFACING COMPONENT
K964472 · Biologically Oriented Prostheses · Feb 1997
AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT
K964381 · Avanta Orthopaedics, Inc. · Jan 1997
STRICKLAND TRAPEZIAL IMPLANT
K951471 · Wrightmedicaltechnologyinc · Aug 1995