Cleared Special

K013527 - MODIFICATION TO SYNTHES (USA) REAMER IR...

K013527 is the FDA 510(k) clearance for MODIFICATION TO SYNTHES (USA) REAMER IR... by Synthes (Usa). It is a Class 1 Orthopedic device (product code HTO) cleared through the Special 510(k) pathway after a 59-day FDA review.

K013527 · Synthes (Usa) · Orthopedic device
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Dec 2001
Decision
59d
Days
Class 1
Risk

K013527 is an FDA 510(k) clearance for the MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM. Classified as Reamer (product code HTO), Class I - General Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on December 21, 2001 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory 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 Synthes (Usa) devices

Submission Details

510(k) Number K013527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2001
Decision Date December 21, 2001
Days to Decision 59 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 122d · This submission: 59d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HTO Reamer
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - HTO Reamer

All 10
Devices cleared under the same product code (HTO) and FDA review panel - the closest regulatory comparables to K013527.
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
K111437 · Synthes USA Products, LLC · Aug 2011
SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
K042899 · Synthes (Usa) · Mar 2005
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
K993335 · Synthes (Usa) · Jun 2000
FLEXIBLE INTRAMEDULLARY REAMER
K954915 · Zimmer, Inc. · Dec 1995
COMBINATION REAMER
K903248 · Onyx Medical Corp. · Jul 1990
ABC-1000 SMALL JOINT REAMERS
K862933 · Instrumentation Industries, Inc. · Aug 1986