Skip to content

Piccolo Composite Nailing System Tibial Nail

by Carbofix Orthopedics Ltd 18 variants

Ref 5PTN11340

Piccolo Composite Nailing System Tibial Nail (5PTN11340) is a device classified as Class IIb in the EU and Class II in the US made by Carbofix Orthopedics Ltd, registered in EUDAMED on 26 Aug 2026 (Basic UDI-DI 729011020CARBOFIX004UK), cleared under FDA 510(k) K132774 on 3 Oct 2013 (2 earlier submissions) and listed in FDA GUDID since 6 Sep 2016 (UDI-DI 07290110200374), active as of 22 Oct 2026. One FDA recall is linked to it.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132774

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number729011020CARBOFIX004UK Basic UDI-DI 07290110200374UDI-DIDate26 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290110200374 UDI-DI Date6 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK132774 Date3 Oct 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 729011020CARBOFIX004UK registered 26 Aug 2026 Active
  • FDA 510(k) K132774 decided 3 Oct 2013 Active· +2 more in the status table
  • FDA GUDID UDI-DI 07290110200374 listed 6 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1991-2016 FDA Class II initiated 10 May 2016

    Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.

Timeline

6 dated events

  1. Cleared FDA 510(k) K102369
  2. Cleared FDA 510(k) K111056
  3. Cleared FDA 510(k) K132774
  4. Recall initiated FDA recalls Z-1991-2016
  5. Listed FDA GUDID 07290110200374
  6. Registered EUDAMED 729011020CARBOFIX004UK

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Piccolo Composite® Tibial Nail EUDAMED
Piccolo Composite Nailing System GUDID
Generic name
Tibia intramedullary nail
Device name
Tibial and Femoral Nails
Model / Ref / Catalog
5PTN11340, Tibial Nail
Primary DI / UDI-DI
07290110200374
Basic UDI-DI
729011020CARBOFIX004UK
510(k) Number
FDA product code
HSB
EMDN code
P09120201 Intramedullary nails
GMDN term
Tibia intramedullary nail
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
888.3020
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Outer Diameter — 11 Millimeter
Length — 340 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
5PTN11340
GUDID
Tibial Nail
Device classEUDAMED
Class IIb
GUDID
Class II

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: Tibia intramedullary nail

Cleared under the same submission (K102369)

and 8 more cleared under K102369

Cleared under the same submission (K111056)

and 8 more cleared under K111056

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS DEVICES, DEVICES FOR TENDON AND LIGAMENT SYNTHESIS.

Other devices from Carbofix Orthopedics Ltd

See all devices from Carbofix Orthopedics Ltd →

Properties

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