Cleared Traditional

K182287 - MEDINAUT Plus (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182287 · Imedicom Co., Ltd. · Orthopedic device
Apr 2019
Decision
226d
Days
Class 2
Risk

K182287 is an FDA 510(k) clearance for the MEDINAUT Plus. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Imedicom Co., Ltd. (Gunpo-Si, KR). The FDA issued a Cleared decision on April 6, 2019 after a review of 226 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - 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.

Submission Details

510(k) Number K182287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2018
Decision Date April 06, 2019
Days to Decision 226 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
110d slower than avg
Panel avg: 116d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 11
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K182287.
VantageTM Lumbar Decompression Kit
K252546 · Allevion Medical, LLC · Mar 2026
MiiS Horus Arthroscope (EJA 100)
K253217 · Medimaging Integrated Solution, Inc (Miis) · Dec 2025
PUREVUE™ FMS
K250795 · W.O.M. World of Medicine GmbH · Dec 2025
Articulator Arthroscopic Bur
K252666 · Joint Preservation Innovations, LLC · Nov 2025
Kyphoplasty Balloon Dilatation Catheters
K252458 · Shanghai Lange Medtech Co., Ltd. · Nov 2025
TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly
K252020 · Hand Biomechanics Lab, Inc. · Oct 2025