Cleared Special

K052098 - CONNEXUS, .5CC, MODEL 023000-005 (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052098 · Isotis Orthobiologics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
35d
Days
Class 2
Risk

K052098 is an FDA 510(k) clearance for the CONNEXUS, .5CC, MODEL 023000-005. Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Isotis Orthobiologics, Inc. (Irvine, US). The FDA issued a Cleared decision on September 7, 2005 after a review of 35 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3045 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Isotis Orthobiologics, Inc. devices

Submission Details

510(k) Number K052098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2005
Decision Date September 07, 2005
Days to Decision 35 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code MQV Filler, Bone Void, Calcium Compound
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3045
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - MQV Filler, Bone Void, Calcium Compound

All 489
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