Cleared Traditional

K945946 - OSTEOMARK(R)

K945946 is an FDA 510(k) clearance for OSTEOMARK, manufactured by Ostex Intl., Inc.. The device is a Class 1 Chemistry device with product code JMM cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K945946 · Ostex Intl., Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
May 1995
Decision
154d
Days
Class 1
Risk

K945946 is an FDA 510(k) clearance for the OSTEOMARK(R). Classified as Column Chromatography & Color Development, Hydroxyproline (product code JMM), Class I - General Controls.

Submitted by Ostex Intl., Inc. (Seattle, US). The FDA issued a Cleared decision on May 8, 1995 after a review of 154 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1400 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Ostex Intl., Inc. devices

FDA 510(k) Submission Details - K945946

510(k) Number K945946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 1994
Decision Date May 08, 1995
Days to Decision 154 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 88d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

JMM Device Classification - Class 1, General Controls

Product Code JMM Column Chromatography & Color Development, Hydroxyproline
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1400
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.