Cleared Traditional

K861450 - SCHURMAN/CARTER HIP PROSTHESIS POROUS C...

K861450 · Kirschner Medical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K861450

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

Device Classification - Class ,

Product Code -
Device Class -