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Juggerknot 110016951

by Biomet Orthopedics, Inc.

Juggerknot 110016951 is a Class II device made by Biomet Orthopedics, Inc., cleared under FDA 510(k) K110145 on 4 Mar 2011 and listed in FDA GUDID since 28 Oct 2016 (UDI-DI 00880304928299), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

510(k) K110145

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00880304928299 UDI-DI Date28 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK110145 Date4 Mar 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110145 decided 4 Mar 2011 Active
  • FDA GUDID UDI-DI 00880304928299 listed 28 Oct 2016 Listed

Recalls

3 recalls · FDA

    • Terminated Z-3252-2018 FDA Class II initiated 3 Aug 2018

    Expiration date incorrectly listed on the label

    • Terminated Z-1828-2016 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.

    • Terminated Z-3109-2011 FDA Unclassified (pre-2012) initiated 21 Jul 2011

    The device packaging was punctured by the device, resulting in loss of implant sterility.

Timeline

5 dated events

  1. Cleared FDA 510(k) K110145
  2. Recall initiated FDA recalls Z-3109-2011
  3. Recall initiated FDA recalls Z-1828-2016
  4. Listed FDA GUDID 00880304928299
  5. Recall initiated FDA recalls Z-3252-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Juggerknot
Generic name
Surgical drill guide, reusable
Model / Ref / Catalog
110016951
Primary DI / UDI-DI
00880304928299
510(k) Number
FDA product code
MBI
GMDN term
Surgical drill guide, reusable
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical drill guide, reusable

Cleared under the same submission (K110145)

and 8 more cleared under K110145

Similar devices in this category

Other devices filed under Surgical drill guide, reusable.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)