Cleared Traditional

K854191 - MECRON UNCEMENTED STRUCTURED STEM HIP (FDA 510(k) Clearance)

K854191 · Mecron Medical Products, Inc. · Orthopedic device
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Nov 1985
Decision
93d
Days
-
Risk

K854191 is an FDA 510(k) clearance for the MECRON UNCEMENTED STRUCTURED STEM HIP.

Submitted by Mecron Medical Products, Inc. (Los Angeles, US). The FDA issued a Cleared decision on November 13, 1985 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 Mecron Medical Products, Inc. devices

Submission Details

510(k) Number K854191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date November 13, 1985
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 -