Cleared Special

K143488 - InFill Graft Delivery System

K143488 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 9-day FDA review.

K143488 · Pinnacle Spine Group, LLC · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
9d
Days
Class 2
Risk

K143488 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 December 17, 2014 after a review of 9 days - a notably fast clearance cycle.

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. 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.

FDA 510(k) Submission Details - K143488

510(k) Number K143488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2014
Decision Date December 17, 2014
Days to Decision 9 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
120d faster than avg
Panel avg: 129d · This submission: 9d
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 K143488.
HumaPen Luxura
K142518 · Eli Lilly and Company · Jun 2015
ConMed Mixing and Delivery Kit
K142535 · Conmed Corporation · Apr 2015
ANUTRA Feedback Aspiration Syringe
K143757 · Anutra Medical, Inc. · Jan 2015
Bi-Portal Bone Graft Delivery Device
K142661 · Spinal Surgical Strategies, LLC · Dec 2014
Merit 10mL Syringe
K142636 · Merit Medical Systems, Inc. · Oct 2014
BIOMET GRAFT DELIVERY SYRINGES
K140710 · Biomet Spine (Aka Ebi, LLC) · Sep 2014