Cleared Traditional

K111632 - INFILL GRAFT DELIVERY SYSTEM

K111632 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 Traditional 510(k) pathway after a 59-day FDA review.

K111632 · Pinnacle Spine Group, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
59d
Days
Class 2
Risk

K111632 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 11, 2011 after a review of 59 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pinnacle Spine Group, LLC devices

FDA 510(k) Submission Details - K111632

510(k) Number K111632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2011
Decision Date August 11, 2011
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 129d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K111632.
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MERIT MEDICAL 20 ML SYRINGE
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K110771 · Becton, Dickinson and Company · May 2011
INDISCAL DIGITAL MANOMETER
K102192 · Baylis Medical Co., Inc. · Feb 2011