Cleared Traditional

K841517 - CLOUTIER II TOTAL KNEE W/BEADED SURF (FDA 510(k) Clearance)

K841517 · Zimmer, Inc. · Orthopedic device
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Aug 1984
Decision
140d
Days
-
Risk

K841517 is an FDA 510(k) clearance for the CLOUTIER II TOTAL KNEE W/BEADED SURF.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 30, 1984 after a review of 140 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 Zimmer, Inc. devices

Submission Details

510(k) Number K841517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 1984
Decision Date August 30, 1984
Days to Decision 140 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -