Cleared Special

K121476 - INFILL GRAFT DELIVERY SYSTEM

K121476 is an FDA 510(k) clearance for INFILL GRAFT DELIVERY SYSTEM, manufactured by Pinnacle Spine Group, LLC. The device is a Class 2 General Hospital device with product code FMF cleared through the Special 510(k) pathway after a 103-day FDA review.

K121476 · Pinnacle Spine Group, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
103d
Days
Class 2
Risk

K121476 is an FDA 510(k) clearance for the INFILL GRAFT DELIVERY SYSTEM. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Pinnacle Spine Group, LLC (Dallas, US). The FDA issued a Cleared decision on August 29, 2012 after a review of 103 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - the FDA general hospital device 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pinnacle Spine Group, LLC devices

FDA 510(k) Submission Details - K121476

510(k) Number K121476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2012
Decision Date August 29, 2012
Days to Decision 103 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 129d · This submission: 103d
Pathway characteristics
Modification to existing cleared device.

FMF Device Classification - Class 2, Special Controls

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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 General Hospital devices follow this clearance model.

Regulatory Peers - FMF Syringe, Piston

All 341
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K121476.
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