Cleared Special

K163308 - SMARTO

K163308 is an FDA 510(k) clearance for SMARTO, manufactured by Jeil Medical Corporation. The device is a Class 1 Orthopedic device with product code KIJ cleared through the Special 510(k) pathway after a 34-day FDA review.

K163308 · Jeil Medical Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
34d
Days
Class 1
Risk

K163308 is an FDA 510(k) clearance for the SMARTO. Classified as Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment (product code KIJ), Class I - General Controls.

Submitted by Jeil Medical Corporation (Seoul, KR). The FDA issued a Cleared decision on December 27, 2016 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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.

FDA 510(k) Submission Details - K163308

510(k) Number K163308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2016
Decision Date December 27, 2016
Days to Decision 34 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
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

KIJ Device Classification - Class 1, General Controls

Product Code KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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 - KIJ Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment

All 28
Devices cleared under the same product code (KIJ) and FDA review panel - the closest regulatory comparables to K163308.
INSURGICAL SINGLE USE POWER EQUIPMENT
K112599 · Insurgical, LLC · Nov 2012
SMARTO
K101563 · Jeil Medical Corporation · Dec 2010
STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENT
K972367 · Stryker Instruments · Sep 1997
STRYKER 2115 REPLACEMENT BATTERY (2115)
K970378 · Implant Resource, Inc. · Apr 1997
ACUMED BONE GRAFT SYSTEM
K960711 · Acu Med, Inc. · May 1996
SYSTEM 2000 REPLACEMENT BATTERY, SYSTEM 2000-EXTENDED RUN REPLACEMENT BATTERY
K951450 · Strenumed, Inc. · May 1995
K163308 · SMARTO
Download PDF FDA Summary Jeil Medical Corporat…