Cleared Traditional

BICONDYLAR TOE PROSTHESIS (K860163) - FDA 510(k) Clearance

K860163 · Depuy, Inc. · Orthopedic device
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Jul 1986
Decision
189d
Days
-
Risk

K860163 is an FDA 510(k) clearance for the BICONDYLAR TOE PROSTHESIS.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 25, 1986 after a review of 189 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. 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 Depuy, Inc. devices

Submission Details

510(k) Number K860163 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1986
Decision Date July 25, 1986
Days to Decision 189 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
67d slower than avg
Panel avg: 122d · This submission: 189d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -