Cleared Traditional

K852137 - FENLIN TOTAL SHOULDER (FDA 510(k) Clearance)

K852137 · Zimmer, Inc. · Orthopedic device
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Feb 1986
Decision
272d
Days
-
Risk

K852137 is an FDA 510(k) clearance for the FENLIN TOTAL SHOULDER.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 12, 1986 after a review of 272 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 Zimmer, Inc. devices

Submission Details

510(k) Number K852137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1985
Decision Date February 12, 1986
Days to Decision 272 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 122d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -