Cleared Traditional

K851409 - UNILOC TOTAL HIP PROSTHESIS (FDA 510(k) Clearance)

K851409 · Serrano Intl. · Orthopedic device
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Nov 1985
Decision
227d
Days
-
Risk

K851409 is an FDA 510(k) clearance for the UNILOC TOTAL HIP PROSTHESIS.

Submitted by Serrano Intl. (Los Angeles, US). The FDA issued a Cleared decision on November 22, 1985 after a review of 227 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 Serrano Intl. devices

Submission Details

510(k) Number K851409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1985
Decision Date November 22, 1985
Days to Decision 227 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 122d · This submission: 227d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -