Cleared Special

K181639 - Panta 2 Arthrodesis Nail System

K181639 is an FDA 510(k) clearance for Panta 2 Arthrodesis Nail System, manufactured by Integra LifeSciences Corporation. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 134-day FDA review.

K181639 · Integra LifeSciences Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2018
Decision
134d
Days
Class 2
Risk

K181639 is an FDA 510(k) clearance for the Panta 2 Arthrodesis Nail System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Integra LifeSciences Corporation (Austin, US). The FDA issued a Cleared decision on November 2, 2018 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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. Standard predicate reliance. 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 - K181639

510(k) Number K181639 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2018
Decision Date November 02, 2018
Days to Decision 134 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
12d slower than avg
Panel avg: 122d · This submission: 134d
Pathway characteristics
Modification to existing cleared device.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 530
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K181639.
Small Bone Phantom® Intramedullary Nail System
K182307 · Paragon 28, Inc. · Jan 2019
Affixus Natural Nail System Humeral Nail
K181827 · Zimmer GmbH · Dec 2018
Affixus Hip Fracture Nail
K183162 · Biomet, Inc. · Dec 2018
OsteoBridge™ IDSF System
K181026 · Merete GmbH · Oct 2018
X-BOLT Hip Fracture Fixation System
K181640 · X-Bolt Orthopaedics · Oct 2018
Double Medical Femoral Nail System
K172830 · Double Medical Technology, Inc. · Aug 2018
K181639 · Panta 2 Arthrodesis Nail System
Download PDF FDA Summary Integra LifeSciences …