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Biomet Tibial Locking Nail System

by Biomet Manufacturing Corp

510(k) K063570

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source 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 Substantially Equivalent · Traditional NumberK063570 Date27 Feb 2007ClearedStatusActive

Recalls

3 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0625-2021 FDA Class II initiated 25 Nov 2020
    • Terminated Z-0627-2021 FDA Class II initiated 25 Nov 2020 on shared 510(k) K063570

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

    • Terminated Z-1819-2016 FDA Class II initiated 1 Apr 2016

    Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

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, 19 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 Biomet Tibial Locking Nail System is an intramedullary orthopedic device designed for the internal fixation of tibial fractures. It provides axial and rotational stability through a locking mechanism to secure proximal oblique screws and facilitate compression for fracture alignment and healing.

This system is supplied as a sterile, single-use device intended for use in orthopedic surgical settings. It is manufactured from titanium alloy and includes a preassembled locking mechanism for proximal screws, with optional inboard compression up to 5mm. The device is regulated under FDA 510(k) clearance (K063570) and is classified under the Orthopedic advisory committee for submission purposes.

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