Cleared Special

K062173 - MODIFICATION TO BONE GRAFT SYRINGE

K062173 is the FDA 510(k) clearance for MODIFICATION TO BONE GRAFT SYRINGE by Wrightmedicaltechnologyinc. It is a Class 2 General Hospital device (product code FMF) cleared through the Special 510(k) pathway after a 23-day FDA review.

K062173 · Wrightmedicaltechnologyinc · General Hospital
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Aug 2006
Decision
23d
Days
Class 2
Risk

K062173 is an FDA 510(k) clearance for the MODIFICATION TO BONE GRAFT SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on August 23, 2006 after a review of 23 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.

View all Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K062173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 2006
Decision Date August 23, 2006
Days to Decision 23 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
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 285
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K062173.
MEDTRONIC GRAFT DELIVERY SYRINGE
K062986 · Medtronic Sofamor Danek USA, Inc. · Dec 2006
INJEKT SYRINGE
K063280 · B.Braun Medical, Inc. · Nov 2006
ARTHREX ASPIRATE KIT
K062365 · Arthrex, Inc. · Sep 2006
MEDLINE SYRINGES, MULTIPLE
K061275 · Medline Industries, Inc. · Jul 2006
MODIFICATION TO: VACLOK SYRINGE
K060095 · Wrightmedicaltechnologyinc · Feb 2006
B. BRAUN 0.2 MICRON FILTER
K052773 · B.Braun Medical, Inc. · Jan 2006