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G7® 010002485

by Biomet Orthopedics, Inc.

Ref 010002485

G7® 010002485 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 31 Oct 2026 (Basic UDI-DI B-00887868460364), cleared under FDA 510(k) K121874 on 23 Nov 2012 and listed in FDA GUDID since 16 Apr 2021 (UDI-DI 00887868460364), active as of 7 Nov 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

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121874

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00887868460364 Basic UDI-DI 00887868460364UDI-DIDate31 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868460364 UDI-DI Date16 Apr 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121874 Date23 Nov 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00887868460364 registered 31 Oct 2026 Active
  • FDA 510(k) K121874 decided 23 Nov 2012 Active
  • FDA GUDID UDI-DI 00887868460364 listed 16 Apr 2021 Listed

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-0007-2023 FDA Class II initiated 25 Aug 2022

    The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery, or infection leading to surgical intervention.

  • 2 recalls, same reason

    • Terminated Z-1837-2014 FDA Class II initiated 7 May 2014
    • Terminated Z-1838-2014 FDA Class II initiated 7 May 2014

    Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.

Timeline

6 dated events

  1. Cleared FDA 510(k) K121874
  2. Recall initiated FDA recalls Z-1837-2014
  3. Recall initiated FDA recalls Z-1838-2014
  4. Listed FDA GUDID 00887868460364
  5. Recall initiated FDA recalls Z-0007-2023
  6. Registered EUDAMED B-00887868460364

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
G7®
Generic name
Femoral head prosthesis trial
Device name
G7 Provisional Head Type 1
Model / Ref / Catalog
010002485
Primary DI / UDI-DI
00887868460364
Basic UDI-DI
B-00887868460364
510(k) Number
FDA product code
OQI, KWZ, OQG, PBI, OQH, LZO, LPH, LWZ, JDI
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Femoral head prosthesis trial
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
888.3353, 888.3310, 888.3358, 888.3350
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 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: Femoral head prosthesis trial

Cleared under the same submission (K121874)

and 8 more cleared under K121874

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE.

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)