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Zimmer Natural Nail System

by Zimmer, Inc.

510(k) K172114

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K172114↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK172114 Date10 Aug 2017ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
HSB
Device class
Class II
Regulation
21 CFR Part 888.3020
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Zimmer Natural Nail System is an intramedullary nail designed for internal fixation of long bone fractures. Its anatomic shape is engineered to replicate the natural contour of bones such as the femur, tibia, and humerus, enabling precise restoration of pre-injury alignment during surgical repair.

This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K172114) and meets MDR requirements, with an advisory committee classification under Orthopedic (OR). The system is available in specific sizes tailored to anatomical applications, requiring sterile handling and proper surgical instrumentation for implantation.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of long bones is the Zimmer Natural Nail System specifically designed to treat, and how does its shape help in surgical repair?

    The Zimmer Natural Nail System is anatomically shaped to match the contours of the femur, tibia, and humerus, allowing surgeons to restore the natural alignment of these bones during fracture fixation. Its design ensures a closer fit to the bone’s natural shape, which may improve stability and reduce the risk of malalignment during healing.

  • Is the Zimmer Natural Nail System reusable, or is it meant for single-use only? How should it be handled to maintain sterility?

    The Zimmer Natural Nail System is explicitly intended for single-use only and is supplied sterile. To preserve sterility, it must be handled using sterile techniques and appropriate surgical instrumentation, as opening or reprocessing the packaging voids its sterile status.

  • Are there multiple sizes available for the Zimmer Natural Nail System, and how are they determined for use?

    Yes, the system comes in specific sizes tailored to anatomical applications, meaning each size is designed to fit particular bone types or fracture patterns. The correct size is determined by preoperative planning and intraoperative assessment to ensure proper fit and fixation.

  • What regulatory pathways does the Zimmer Natural Nail System follow, and how does this affect its availability?

    The device is cleared under the FDA 510(k) pathway (K172114) with a classification as substantially equivalent, and it also complies with MDR (Medical Device Regulation) requirements. This means it is legally marketed in the U.S. and EU (where MDR applies) after undergoing rigorous review, ensuring its safety and performance for internal fixation of long bone fractures.