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Toggleloc Xtender; Toggleloc Xl; Implant Kit Toggleloc; Implant Kit Toggleloc Btb, Extended Toggleloc; Toggleloc; Btb to

by Biomet Manufacturing Corp

510(k) K130033

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK130033 Date1 Aug 2013ClearedStatusActive

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0212-2026 FDA Class II initiated 23 Sep 2025

    There is a potential for a missing slotted button assembly in one lot of ZipTight, Acute AC Joint Implant, Single Ziploop

    • Terminated Z-0818-2018 FDA Class II initiated 22 Aug 2017

    Ziptight Ankle Syndesmosis Fixation was packaged without the tip protectors.

    • Terminated Z-1363-2015 FDA Class II initiated 26 Feb 2015 on shared 510(k) K130033

    The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.

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  • Withdrawn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
MBI
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 888.3040
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

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