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Phoenix Nail System 14-405105

by Biomet Orthopedics, Inc.

Ref 14-405105

Phoenix Nail System 14-405105 is a device classified as Class IIb in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI B-00887868092794), cleared under FDA 510(k) K063570 on 27 Feb 2007 (1 earlier submission) and listed in FDA GUDID since 24 Oct 2015 (UDI-DI 00887868092794), 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

None ongoing

5 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K063570

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00887868092794 Basic UDI-DI 00887868092794UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868092794 UDI-DI Date24 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK063570 Date27 Feb 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00887868092794 registered 24 Oct 2026 Active
  • FDA 510(k) K063570 decided 27 Feb 2007 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00887868092794 listed 24 Oct 2015 Listed

Recalls

5 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0625-2021 FDA Class II initiated 25 Nov 2020
    • Terminated Z-0627-2021 FDA Class II initiated 25 Nov 2020 on shared 510(k) K063570

    Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

    • Terminated Z-1819-2016 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-1478-2012 FDA Not yet classified initiated 30 Mar 2012

    The Trochanteric Nail, lot 486130, was mislabeled as a right nail orientation but the contents are actually a left nail orientation

    • Terminated Z-0012-06 FDA Unclassified (pre-2012) initiated 24 Jun 2005 on shared 510(k) K050118

    Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

9 dated events

  1. Cleared FDA 510(k) K050118
  2. Recall initiated FDA recalls Z-0012-06
  3. Cleared FDA 510(k) K063570
  4. Recall initiated FDA recalls Z-1478-2012
  5. Listed FDA GUDID 00887868092794
  6. Recall initiated FDA recalls Z-1819-2016
  7. Recall initiated FDA recalls Z-0625-2021
  8. Recall initiated FDA recalls Z-0627-2021
  9. Registered EUDAMED B-00887868092794

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
Phoenix Nail System
Generic name
Orthopaedic bone screw, non-bioabsorbable, sterile
Device name
MFX s nail Phoenix Cortical 5.0mm
Model / Ref / Catalog
14-405105
Primary DI / UDI-DI
00887868092794
Basic UDI-DI
B-00887868092794
510(k) Number
FDA product code
HSB
EMDN code
P09120601 Cortical screws
GMDN term
Orthopaedic bone screw, non-bioabsorbable, sterile
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIb 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 bone screw, non-bioabsorbable, sterile

Cleared under the same submission (K050118)

and 8 more cleared under K050118

Cleared under the same submission (K063570)

and 8 more cleared under K063570

Similar devices in this category

Other devices filed under CORTICAL SCREWS.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)