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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
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 569
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K121476.
REGEN SPRAY APPLICATOR,
K122122 · Regen Lab SA · Nov 2012
MIXJECT WITH SPRAY HEAD
K122023 · Medimop Medical Projects, Ltd. · Oct 2012
NEOMED ORAL/ENTERAL SYRINGE
K122373 · Neomed, Inc. · Sep 2012
MYSAFETY SYRINGE
K113673 · Medicalchain Internartional Corporation · Aug 2012
BD EMERALD SAF-T SINGLE USE, HYPODERMIC
K121283 · Becton, Dickinson and Company · May 2012
ARTHREX MIXING AND DELIVERY SYSTEM
K121124 · Arthrex, Inc. · May 2012