Cleared Traditional

K863528 - BICONDYLAR TOE PROSTHESIS (FDA 510(k) Clearance)

K863528 · Depuy, Inc. · Orthopedic device
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Sep 1986
Decision
19d
Days
-
Risk

K863528 is an FDA 510(k) clearance for the BICONDYLAR TOE PROSTHESIS.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 19 days - a notably fast clearance 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: 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 Depuy, Inc. devices

Submission Details

510(k) Number K863528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1986
Decision Date September 29, 1986
Days to Decision 19 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
103d faster than avg
Panel avg: 122d · This submission: 19d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -