Cleared Traditional

K801313 - COMPRESSION MOLDING OF UHMWPE (FDA 510(k) Clearance)

K801313 · Howmedica Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1980
Decision
6d
Days
-
Risk

K801313 is an FDA 510(k) clearance for the COMPRESSION MOLDING OF UHMWPE.

Submitted by Howmedica Corp. (Mchenry, US). The FDA issued a Cleared decision on June 9, 1980 after a review of 6 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 K801313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1980
Decision Date June 09, 1980
Days to Decision 6 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 122d · This submission: 6d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -