Cleared Traditional

K841517 - CLOUTIER II TOTAL KNEE W/BEADED SURF

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

FDA 510(k) Submission Details - K841517

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 122d · This submission: 140d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -