Cleared Traditional

K851409 - UNILOC TOTAL HIP PROSTHESIS

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

FDA 510(k) Submission Details - K851409

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 - Class ,

Product Code -
Device Class -