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JuggerKnot® 916036

by Biomet Orthopedics, Inc.

Ref 916036

JuggerKnot® 916036 is a device classified as Class IIa in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 20 Oct 2026 (Basic UDI-DI B-00887868511950), cleared under FDA 510(k) K150768 on 4 Sep 2015 (1 earlier submission) and listed in FDA GUDID since 17 Dec 2021 (UDI-DI 00887868511950), active as of 24 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K150768

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00887868511950 Basic UDI-DI 00887868511950UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868511950 UDI-DI Date17 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK150768 Date4 Sep 2015DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00887868511950 registered 20 Oct 2026 Active
  • FDA 510(k) K150768 decided 4 Sep 2015 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00887868511950 listed 17 Dec 2021 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

7 dated events

  1. Cleared FDA 510(k) K110145
  2. Recall initiated FDA recalls Z-3109-2011
  3. Cleared FDA 510(k) K150768
  4. Recall initiated FDA recalls Z-1828-2016
  5. Recall initiated FDA recalls Z-3252-2018
  6. Listed FDA GUDID 00887868511950
  7. Registered EUDAMED B-00887868511950

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
JuggerKnot®
Generic name
Fluted surgical drill bit, single-use
Device name
SM JKLong Spade Tip Flexible Drill Bit
Model / Ref / Catalog
916036
Primary DI / UDI-DI
00887868511950
Basic UDI-DI
B-00887868511950
510(k) Number
FDA product code
MBI
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Fluted surgical drill bit, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3040
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Fluted surgical drill bit, single-use

Cleared under the same submission (K110145)

and 8 more cleared under K110145

Cleared under the same submission (K150768)

and 8 more cleared under K150768

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)