Panta 500180ND

• FDA 510(k) K091788 decided 29 Jul 2009 Active· +1 more in the status table
• FDA GUDID UDI-DI 10381780044529 listed 9 Oct 2017 Listed

• • Terminated Z-1539-2017 FDA Class II ·initiated 3 Mar 2017

  Voluntary recall/Removal of Panta and Panta XI Nails because there may be the potential that the internal and external package seal does not provide the level of sterility intended.

• • Terminated Z-1736-2013 FDA Class II ·initiated 9 May 2013

  As a result of the investigation into an adverse trend of complaints for reports of misalignment of the calcaneal or tibial screws during use of the Panta Nail Support Device, Integra has decided to issue this voluntary medical device correction. The misalignment can result in the inability to properly insert the screws into the Panta Nail and create the potential need for revision surgery.

• • Terminated Z-1428-2012 FDA Unclassified (pre-2012) ·initiated 19 May 2011

  The firm received multiple complaints from their user customers (surgeons) who reported encountering difficulty inserting a calcaneal or tibial screw through the holes of the PANTA nail.

• • Terminated Z-0308-2011 FDA Unclassified (pre-2012) ·initiated 1 Mar 2010

  Inability to properly align the calcaneal screw placement on a consistent basis, due to a manufacturing defect of of the targeting frame (Panta Support Device).

• • Terminated Z-1877-2008 FDA Unclassified (pre-2012) ·initiated 24 Mar 2008

  Certain PANTA Nails from one lot were incorrectly manufactured. The internal thread for certain PANTA Nails (Part Number 500050ND; Lot Number: E7XX) may present an insufficient depth and may not allow the engagement of the threaded part of the compression device. The risks presented include: an increase in surgery time, or the implantation of a nail less ideally suited for the patient's anatomy

1. 27 May 2005 Cleared FDA 510(k) K050882
2. 24 Mar 2008 Recall initiated FDA recalls Z-1877-2008
3. 29 Jul 2009 Cleared FDA 510(k) K091788
4. 1 Mar 2010 Recall initiated FDA recalls Z-0308-2011
5. 19 May 2011 Recall initiated FDA recalls Z-1428-2012
6. 9 May 2013 Recall initiated FDA recalls Z-1736-2013
7. 3 Mar 2017 Recall initiated FDA recalls Z-1539-2017
8. 9 Oct 2017 Listed FDA GUDID 10381780044529

Trade name

Panta

Generic name

Arthrodesis intramedullary nail, non-distracting

Model / Ref / Catalog

500180ND

Primary DI / UDI-DI

10381780044529

510(k) Number

K050882 ↗

K091788 ↗

FDA product code

HSB

GMDN term

Arthrodesis intramedullary nail, non-distracting

Device class

Class II

Regulation number

888.3020

GUDID distribution status

In Commercial Distribution

Category: Arthrodesis intramedullary nail, non-distracting

• SURFIX Alpha 295210SND

  Class II

  FDA 510(k) K083154 Active Cleared 10 Jul 2009 GUDID on market

• Large Qwix® 119177ND

  Class I

  GUDID on market

• Panta 501075ND

  Class II

  FDA 510(k) ×2 Active Cleared 27 May 2005 GUDID on market

• Panta 500080ND

  Class II

  FDA 510(k) K091788 Active Cleared 29 Jul 2009 GUDID on market

See all devices from Newdeal Sas →