Cleared Traditional

MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE. (K864631) - FDA 510(k) Clearance

K864631 · Downs Surgical , Ltd. · Orthopedic device
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Dec 1986
Decision
23d
Days
-
Risk

K864631 is an FDA 510(k) clearance for the MOORE'S STRAIGHT & THOMPSON'S CURVED STEM PROSTHE..

Submitted by Downs Surgical , Ltd. (Mitcham Surrey, GB). The FDA issued a Cleared decision on December 18, 1986 after a review of 23 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 Downs Surgical , Ltd. devices

Submission Details

510(k) Number K864631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1986
Decision Date December 18, 1986
Days to Decision 23 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 122d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -