Cleared Special

K242280 - Vitoss BiModal Bioactive Bone Graft Sub...

K242280 is the FDA 510(k) clearance for Vitoss BiModal Bioactive Bone Graft Sub... by Stryker Spine. It is a Class 2 Orthopedic device (product code MQV) cleared through the Special 510(k) pathway after a 27-day FDA review.

K242280 · Stryker Spine · Orthopedic device
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Aug 2024
Decision
27d
Days
Class 2
Risk

K242280 is an FDA 510(k) clearance for the Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal B.... Classified as Filler, Bone Void, Calcium Compound (product code MQV), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on August 29, 2024 after a review of 27 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 Stryker Spine devices

Submission Details

510(k) Number K242280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2024
Decision Date August 29, 2024
Days to Decision 27 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 122d · This submission: 27d
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 230
Devices cleared under the same product code (MQV) and FDA review panel - the closest regulatory comparables to K242280.
Mg OSTEOREVIVE™, Mg OSTEOCRETE™
K242372 · Bone Solutions, Inc. · Oct 2024
Cove Putty, OsteoCove Putty
K242273 · SeaSpine Orthopedics Corporation · Sep 2024
NovaBone Putty - Synthetic Bioactive Bone Graft
K242299 · Novabone Products, LLC · Sep 2024
Montage-XT Settable, Resorbable Bone Putty
K233566 · Orthocon, Inc. · Aug 2024
Actifuse ABX
K241564 · Baxter Healthcare Corporation · Aug 2024
Montage Settable Bone Putty
K242050 · Orthocon, Inc. · Jul 2024