Cleared Traditional

Phantom Small Bone Intramedullary Nail System (K170693) - FDA 510(k) Clearance

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

K170693 · Paragon 28, Inc. · Orthopedic device
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Jun 2017
Decision
104d
Days
Class 2
Risk

K170693 is an FDA 510(k) clearance for the Phantom Small Bone Intramedullary Nail System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Single Component (product code KTW), Class II - Special Controls.

Submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on June 19, 2017 after a review of 104 days - within the typical 510(k) review window.

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. 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 Paragon 28, Inc. devices

Submission Details

510(k) Number K170693 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2017
Decision Date June 19, 2017
Days to Decision 104 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 37
Devices cleared under the same product code (KTW) and FDA review panel - the closest regulatory comparables to K170693.
PK High Tibial Osteotomy Correction System
K182285 · Paonan Biotech Co., Ltd. · Jun 2019
SYNTHES (USA) MODULAR BLADE PLATE SYSTEM
K080109 · Synthes (Usa) · Mar 2008
SYNTHES LCP PROXIMAL HUMERUS PLATES
K011815 · Synthes (Usa) · Sep 2001
SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM
K011458 · Synthes (Usa) · Aug 2001
MODULAR FOOT SYSTEM - 2.7 MM MODULE
K010321 · Synthes (Usa) · May 2001
STRYKER TRAUMA PELVIC SET
K001614 · Howmedica Osteonics Corp. · Aug 2000