Cleared Traditional

K953961 - OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM (FDA 510(k) Clearance)

Class I General Hospital device.

K953961 · Osteonics Corp. · General Hospital
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Nov 1995
Decision
99d
Days
Class 1
Risk

K953961 is an FDA 510(k) clearance for the OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM. Classified as Table, Operating-room, Pneumatic (product code FWW), Class I - General Controls.

Submitted by Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on November 29, 1995 after a review of 99 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4960 - the FDA general hospital device framework. 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Osteonics Corp. devices

Submission Details

510(k) Number K953961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1995
Decision Date November 29, 1995
Days to Decision 99 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 128d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FWW Table, Operating-room, Pneumatic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4960
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.