Cleared Traditional

K852137 - FENLIN TOTAL SHOULDER

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

FDA 510(k) Submission Details - K852137

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 122d · This submission: 272d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -