Cleared Traditional

K810518 - CAST HIPPED VITALLIUM (FDA 510(k) Clearance)

K810518 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1981
Decision
27d
Days
-
Risk

K810518 is an FDA 510(k) clearance for the CAST HIPPED VITALLIUM.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1981 after a review of 27 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Howmedica Corp. devices

Submission Details

510(k) Number K810518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1981
Decision Date March 24, 1981
Days to Decision 27 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -