Cleared Traditional

K182285 - PK High Tibial Osteotomy Correction System

K182285 is an FDA 510(k) clearance for PK High Tibial Osteotomy Correction System, manufactured by Paonan Biotech Co., Ltd.. The device is a Class 2 Orthopedic device with product code KTW cleared through the Traditional 510(k) pathway after a 301-day FDA review.

K182285 · Paonan Biotech Co., Ltd. · Orthopedic device
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Jun 2019
Decision
301d
Days
Class 2
Risk

K182285 is an FDA 510(k) clearance for the PK High Tibial Osteotomy Correction System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Paonan Biotech Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on June 20, 2019 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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. Elevated predicate reliance profile. 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 Paonan Biotech Co., Ltd. devices

FDA 510(k) Submission Details - K182285

510(k) Number K182285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2018
Decision Date June 20, 2019
Days to Decision 301 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
179d slower than avg
Panel avg: 122d · This submission: 301d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTW Device Classification - Class 2, Special Controls

Product Code KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTW Appliance, Fixation, Nail/blade/plate Combination, Single Component

All 28
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K182285.
Phantom Small Bone Intramedullary Nail System
K170693 · Paragon 28, Inc. · Jun 2017
AOS Anterolateral Proximal Humeral Plate
K160409 · Advanced Orthopaedic Solutions, Inc. · Mar 2016
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
K122541 · Orthofix Srl · Sep 2012
AOS PROXIMAL HUMERAL PLATE
K080590 · Advanced Orthopaedic Solutions, Inc. · May 2008
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
K080109 · Synthes (Usa) · Mar 2008
ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP
K062920 · Orthofix Srl · Nov 2006