Cleared Traditional

K863554 - THACKRAY CRUCIATE SPARING KNEE CS-1 (FDA 510(k) Clearance)

K863554 · Thackray USA · Orthopedic device
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Oct 1986
Decision
24d
Days
-
Risk

K863554 is an FDA 510(k) clearance for the THACKRAY CRUCIATE SPARING KNEE CS-1.

Submitted by Thackray USA (Ringoes, US). The FDA issued a Cleared decision on October 6, 1986 after a review of 24 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 Thackray USA devices

Submission Details

510(k) Number K863554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1986
Decision Date October 06, 1986
Days to Decision 24 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 122d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -