Cleared Traditional

K854621 - ISOSTATION KNEE MACHINE (K-100) (FDA 510(k) Clearance)

K854621 · Isotechnologies, Inc. · Orthopedic device
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Mar 1986
Decision
109d
Days
-
Risk

K854621 is an FDA 510(k) clearance for the ISOSTATION KNEE MACHINE (K-100).

Submitted by Isotechnologies, Inc. (Hillsborough, US). The FDA issued a Cleared decision on March 7, 1986 after a review of 109 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 Isotechnologies, Inc. devices

Submission Details

510(k) Number K854621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date March 07, 1986
Days to Decision 109 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 122d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -