Cleared Traditional

K231114 - Zimmer Natural Nail System Cephalomedul...

Also marketed or referenced as:
Affixus® Natural Nail® Humeral Nail System

K231114 is an FDA 510(k) clearance for Zimmer Natural Nail System Cephalomedul..., manufactured by Zimmer Switzerland Manufacturing GmbH. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K231114 · Zimmer Switzerland Manufacturing GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
112d
Days
Class 2
Risk

K231114 is an FDA 510(k) clearance for the Zimmer® Natural Nail® System Cephalomedullary Nails. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Zimmer Switzerland Manufacturing GmbH (Winterthur, CH). The FDA issued a Cleared decision on August 9, 2023 after a review of 112 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. 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 Zimmer Switzerland Manufacturing GmbH devices

FDA 510(k) Submission Details - K231114

510(k) Number K231114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2023
Decision Date August 09, 2023
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 365
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K231114.
Tornier Humeral Nail and Tornier Long Humeral Nail
K230352 · Tornier, Inc. · Oct 2023
Precice Ankle Salvage System
K230765 · Nuvasive Specialized Orthopedics, Inc. · Aug 2023
Pediatric Nailing Platform Tibia
K231266 · OrthoPediatrics Corp. · Aug 2023
Arthrex Intramedullary Nails
K230257 · Arthrex, Inc. · Jul 2023
SGM Femoral Nail System
K230456 · Changzhou Geasure Medical Apparatus and Instruments Co., Ltd. · Jun 2023
Gamma4 System
K230512 · Stryker GmbH · Jun 2023