Panta
The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 10mm, 11mm, 12mm and 13mm, and lengths of 150mm, 180mm, 210mm and 240mm. Holes in the nail…
The NEWDEAL Ankle Nail is a straight, cannulated intramedullary nail available in diameters of 10mm, 11mm, 12mm and 13mm, and lengths of 150mm, 180mm, 210mm and 240mm. Holes in the nail allow for proximal and distal locking, using locking cortical screws 5mm diameter, 20 to 110mm long. The nail is made from Titanium alloy.
17manufacturers in China registered for this device type
53catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | Newdeal Sas, United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| 510(k) | K091788 |
| Record published | 2017-10-09 |
| Record revised | 2025-02-06 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Store in dry place |
| Distribution end date | 2027-04-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 501022ND | 5.0mm diam. x 22.5mm length | In distribution |
| 501105ND | 5.0mm diam. x 105mm length | In distribution |
| 511090ND | 5.0mm diam. x 90mm length | In distribution |
| 501070ND | 5.0mm diam. x 70mm length | In distribution |
| 500350ND | 13.0mm diam. x 150mm length | In distribution |
| 501080ND | 5.0mm diam. x 80mm length | In distribution |
| 511065ND | 5.0mm diam. x 65mm length | In distribution |
| 500050ND | 10mm diam. x 150mm length | In distribution |
| 511100ND | 5.0mm diam. x 100mm length | In distribution |
| 511030ND | 5.0mm diam. x 30mm length | In distribution |
| 501035ND | 5.0mm diam. x 35mm length | In distribution |
| 511055ND | 5.0mm diam. x 55mm length | In distribution |
| 501050ND | 5.0mm diam. x 50mm length | In distribution |
| 500001ND | 6.0mm diam. x 7.2mm length | In distribution |
| 511050ND | 5.0mm diam. x 50mm length | In distribution |
| 501027ND | 5.0mm diam. x 27.5mm length | In distribution |
| 511095ND | 5.0mm diam. x 95mm length | In distribution |
| 500280ND | 12mm diam. x 183mm length | In distribution |
| 501040ND | 5.0mm diam. x 40mm length | In distribution |
| 511080ND | 5.0mm diam. x 80mm length | In distribution |
| 500380ND | 13.0mm diam. x 183mm length | In distribution |
| 511022ND | 5.0mm diam. x 22.5mm length | In distribution |
| 511025ND | 5.0mm diam. x 25mm length | In distribution |
| 501075ND | 5.0mm diam. x 75mm length | In distribution |
| 501045ND | 5.0mm diam. x 45mm length | In distribution |
| 511085ND | 5.0mm diam. x 85mm length | In distribution |
| 501060ND | 5.0mm diam. x 60mm length | In distribution |
| 511035ND | 5.0mm diam. x 35mm length | In distribution |
| 501110ND | 5.0mm diam. x 110mm length | In distribution |
| 511075ND | 5.0mm diam. x 75mm length | In distribution |
| 511105ND | 5.0mm diam. x 105mm length | In distribution |
| 501095ND | 5.0mm diam. x 95mm length | In distribution |
| 511027ND | 5.0mm diam. x 27.5mm length | In distribution |
| 500150ND | 11mm diam. x 150mm length | In distribution |
| 511070ND | 5.0mm diam. x 70mm length | In distribution |
| 511040ND | 5.0mm diam. x 40mm length | In distribution |
| 501100ND | 5.0mm diam. x 100mm length | In distribution |
| 501020ND | 5.0mm diam. x 20mm length | In distribution |
| 500180ND | 11mm diam. x 183mm length | In distribution |
| 501085ND | 5.0mm diam. x 85mm length | In distribution |
| 511060ND | 5.0mm diam. x 60mm length | In distribution |
| 501025ND | 5.0mm diam. x 25mm length | In distribution |
| 501030ND | 5.0mm diam. x 30mm length | In distribution |
| 511020ND | 5.0mm diam. x 20mm length | In distribution |
| 501065ND | 5.0mm diam. x 65mm length | In distribution |
| 500080ND | 10mm diam. x 183mm length | In distribution |
| 511045ND | 5.0mm diam. x 45mm length | In distribution |
| 511110ND | 5.0mm diam. x 110mm length | In distribution |
| 501055ND | 5.0mm diam. x 55mm length | In distribution |
| 500250ND | 12mm diam. x 150mm length | In distribution |
| 501090ND | 5.0mm diam. x 90mm length | In distribution |
| REPANTASET | Withdrawn | |
| PANTAINSTSET | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091788 | 2009-07-29 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Integra Lifesciences Corporation | 510(k) number | 2017-03-03 | Class II | Packaging change control | 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. | 4,449 units | 2018-05-21 |
| Integra Lifesciences Corporation | 510(k) number | 2013-05-09 | Class II | Device Design | 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 corre | 692 | 2013-11-07 |
| Integra Lifesciences Corporation | 510(k) number | 2011-05-19 | Not classified | Use error | 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. | 64 units were distributed | 2013-02-19 |
| Integra Lifesciences Corporation | 510(k) number | 2010-03-01 | Not classified | Nonconforming Material/Component | 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). | 108 Units | 2012-02-16 |
| Integra Lifesciences Corporation | 510(k) number | 2008-03-24 | Not classified | Process control | 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 | 45 units received in US, 22 were distributed. | 2008-09-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.