Cleared Traditional

K861450 - SCHURMAN/CARTER HIP PROSTHESIS POROUS COATED (FDA 510(k) Clearance)

K861450 · Kirschner Medical Corp. · Orthopedic device
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Aug 1986
Decision
111d
Days
-
Risk

K861450 is an FDA 510(k) clearance for the SCHURMAN/CARTER HIP PROSTHESIS POROUS COATED.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on August 7, 1986 after a review of 111 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 Kirschner Medical Corp. devices

Submission Details

510(k) Number K861450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1986
Decision Date August 07, 1986
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -