Cleared Special

K200814 - Affixus Natural Nail System Humeral Nail

K200814 is the FDA 510(k) clearance for Affixus Natural Nail System Humeral Nail by Zimmer GmbH. It is a Class 2 Orthopedic device (product code HSB) cleared through the Special 510(k) pathway after a 29-day FDA review.

K200814 · Zimmer GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
29d
Days
Class 2
Risk

K200814 is an FDA 510(k) clearance for the Affixus(R) Natural Nail(R) System Humeral Nail. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Zimmer GmbH (Winterthur, CH). The FDA issued a Cleared decision on April 28, 2020 after a review of 29 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zimmer GmbH devices

Submission Details

510(k) Number K200814 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2020
Decision Date April 28, 2020
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K200814.
The Simple Locking Intramedullary (Slim) System
K192710 · Pega Medical, Inc. · Jun 2020
PRECICE Bone Transport System
K193016 · Nuvasive Specialized Orthopedics, Inc. · May 2020
Precice® Screws
K193617 · Nuvasive Specialized Orthopedics, Inc. · May 2020
T2 Alpha Tibia Nailing System, IMN Screws System
K193308 · Stryker Trauma GmbH · Feb 2020
TTC Phantom® Intramedullary Nail System
K192163 · Paragon 28, Inc. · Jan 2020
EBA One Nailing System
K183666 · Citieffe S.R.L. · Nov 2019