Cleared Traditional

K101563 - SMARTO

K101563 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 Traditional 510(k) pathway after a 196-day FDA review.

K101563 · Jeil Medical Corporation · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
196d
Days
Class 1
Risk

K101563 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 17, 2010 after a review of 196 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.4820 - 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 Jeil Medical Corporation devices

FDA 510(k) Submission Details - K101563

510(k) Number K101563 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2010
Decision Date December 17, 2010
Days to Decision 196 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
74d slower than avg
Panel avg: 122d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

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 16
Devices cleared under the same product code (KIJ) and FDA review panel - the closest regulatory comparables to K101563.
SMARTO
K163308 · Jeil Medical Corporation · Dec 2016
INSURGICAL SINGLE USE POWER EQUIPMENT
K112599 · Insurgical, LLC · Nov 2012
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
ARTHREX GRAFT HARVESTING KIT
K941285 · Arthrex, Inc. · Nov 1994