Cleared Special

K261008 - Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip (FDA 510(k) Clearance)

Also includes:

Vitoss® BiModal Bioactive Bone Graft Substitute Vitoss BBTrauma® Bioactive Bone Graft Substitute Vitoss® BA2X Bioactive Bone Graft Substitute Vitoss® Bioactive Foam Bone Graft Substitute Pack Vitoss® Bioactive Foam Bone Graft Substitute Vitoss® Foam Bone Graft Substitute Vitoss® Bone Graft Substitute Filled Canister Vitoss® Bone Graft Substitute

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

K261008 · Stryker Spine · Orthopedic device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Apr 2026

Decision

29d

Days

Class 2

Risk

K261008 is an FDA 510(k) clearance for the Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip. 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 April 24, 2026 after a review of 29 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	K261008 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 26, 2026
Decision Date	April 24, 2026
Days to Decision	29 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

93d faster than avg

Panel avg: 122d · This submission: 29d

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.