Cleared Traditional

K801934 - WORRELL PATELLA FEMORAL SHIELD (FDA 510(k) Clearance)

K801934 · Depuy, Inc. · Orthopedic device
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Nov 1980
Decision
93d
Days
-
Risk

K801934 is an FDA 510(k) clearance for the WORRELL PATELLA FEMORAL SHIELD.

Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 13, 1980 after a review of 93 days - within the typical 510(k) review window.

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 K801934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1980
Decision Date November 13, 1980
Days to Decision 93 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 122d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -