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JuggerKnot® 912035C

by Biomet Orthopedics, Inc.

Ref 912035C

JuggerKnot® 912035C is a device classified as Class I 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-00887868569258), cleared under FDA 510(k) K150768 on 4 Sep 2015 (1 earlier submission) and listed in FDA GUDID since 29 May 2023 (UDI-DI 00887868569258), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00887868569258 Basic UDI-DI 00887868569258UDI-DIDate20 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868569258 UDI-DI Date29 May 2023ListedStatusListed 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-00887868569258 registered 20 Oct 2026 Active
  • FDA 510(k) K150768 decided 4 Sep 2015 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00887868569258 listed 29 May 2023 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 00887868569258
  7. Registered EUDAMED B-00887868569258

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
Orthopaedic implantation sleeve, reusable
Device name
SM JK 1_4 and 1_5 Reusable Curved Guide
Model / Ref / Catalog
912035C
Primary DI / UDI-DI
00887868569258
Basic UDI-DI
B-00887868569258
510(k) Number
FDA product code
MBI
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Orthopaedic implantation sleeve, reusable
Device class
Class I 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
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Orthopaedic implantation sleeve, reusable

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 PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Lot / batch number
Other properties (21, all answered No)