Cleared Traditional

K993335 - SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM

K993335 is an FDA 510(k) clearance for SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA..., manufactured by Synthes (Usa). The device is a Class 1 Orthopedic device with product code HTO cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K993335 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2000
Decision
252d
Days
Class 1
Risk

K993335 is an FDA 510(k) clearance for the SYNTHES 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 June 12, 2000 after a review of 252 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes (Usa) devices

FDA 510(k) Submission Details - K993335

510(k) Number K993335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1999
Decision Date June 12, 2000
Days to Decision 252 days
Submission Type Traditional
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
130d slower than avg
Panel avg: 122d · This submission: 252d
Pathway characteristics
Predicate-based equivalence.

HTO Device Classification - Class 1, General Controls

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 11
Devices cleared under the same product code (HTO) and FDA review panel - the closest regulatory comparables to K993335.
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
K111437 · Synthes USA Products, LLC · Aug 2011
SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
K042899 · Synthes (Usa) · Mar 2005
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
K013527 · Synthes (Usa) · Dec 2001
FLEXIBLE INTRAMEDULLARY REAMER
K954915 · Zimmer, Inc. · Dec 1995
COMBINATION REAMER
K903248 · Onyx Medical Corp. · Jul 1990
WARSAW ORTHOPEDIC POINTED REAMER
K870845 · Warsaw Orthopedic, Inc. · Mar 1987