Cleared Traditional

K840271 - CEMENTLESS HIP PROSTHESIS (FDA 510(k) Clearance)

K840271 · Mecron Medical Products, Inc. · Orthopedic device
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Jul 1984
Decision
162d
Days
-
Risk

K840271 is an FDA 510(k) clearance for the CEMENTLESS HIP PROSTHESIS.

Submitted by Mecron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 3, 1984 after a review of 162 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 Mecron Medical Products, Inc. devices

Submission Details

510(k) Number K840271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1984
Decision Date July 03, 1984
Days to Decision 162 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d slower than avg
Panel avg: 122d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -