Phantom Hindfoot TTC/TC Nail System
Phantom Screw Driver Attachment, Cannulated, 3/16" Sq. Connection, TX-30 x 85mm
17manufacturers in China registered for this device type
236catalogue numbers in this listing
8510(k) clearances naming this product code
4recalls on this code
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 | Paragon 28, United States |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K201227 |
| Record published | 2022-10-14 |
| Record revised | 2025-04-22 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P31-615-300R-S | In distribution | |
| P31-815-200L-S | In distribution | |
| P31-102-3000-S | In distribution | |
| P31-950-0002 | In distribution | |
| P31-315-300L-S | In distribution | |
| P31-630-175L-S | In distribution | |
| P32-270-1258-S | In distribution | |
| P32-270-1256-S | In distribution | |
| P31-600-300L-S | In distribution | |
| P99-100-4634 | In distribution | |
| P31-950-0004 | In distribution | |
| P31-330-150L-S | In distribution | |
| P31-815-250L-S | In distribution | |
| P31-630-200L-S | In distribution | |
| P31-430-2000-S | In distribution | |
| P31-330-175R-S | In distribution | |
| P31-415-2000-S | In distribution | |
| P31-315-150L-S | In distribution | |
| P31-901-TRY1 | In distribution | |
| P31-101-0000-05 | In distribution | |
| P31-130-2500-S | In distribution | |
| P31-230-2500-S | In distribution | |
| P31-800-150R-S | In distribution | |
| P31-215-2000-S | In distribution | |
| P31-230-2500-S | In distribution | |
| P31-115-3000-S | In distribution | |
| P31-102-0005 | In distribution | |
| P31-800-350R-S | In distribution | |
| P31-130-2000-S | In distribution | |
| P31-315-200R-S | In distribution | |
| P31-630-250R-S | In distribution | |
| P31-111-0000-07 | In distribution | |
| P31-600-300R-S | In distribution | |
| P31-315-200R-S | In distribution | |
| P31-202-2500-S | In distribution | |
| P31-600-200L-S | In distribution | |
| P31-600-200R-S | In distribution | |
| P31-830-350R-S | In distribution | |
| P31-300-300L-S | In distribution | |
| P31-300-150R-S | In distribution | |
| P31-800-350L-S | In distribution | |
| P31-600-250R-S | In distribution | |
| P31-615-200L-S | In distribution | |
| P31-100-0003 | In distribution | |
| P31-830-150L-S | In distribution | |
| P31-830-200L-S | In distribution | |
| P32-950-0100-R | In distribution | |
| P31-330-150L-S | In distribution | |
| P31-115-3000-S | In distribution | |
| P31-615-175R-S | In distribution | |
| P31-600-250R-S | In distribution | |
| P32-950-0002 | In distribution | |
| P31-215-3000-S | In distribution | |
| P31-100-0001 | In distribution | |
| P31-615-300L-S | In distribution | |
| P31-430-2500-S | In distribution | |
| P31-130-1750-S | In distribution | |
| P32-959-0145 | In distribution | |
| P31-600-200R-S | In distribution | |
| P31-100-1015-01 | In distribution | |
| P31-102-2000-S | In distribution | |
| P31-800-200L-S | In distribution | |
| P31-630-250L-S | In distribution | |
| P31-430-1500-S | In distribution | |
| P31-300-300R-S | In distribution | |
| P31-600-200L-S | In distribution | |
| P31-102-1750-S | In distribution | |
| P31-815-350R-S | In distribution | |
| P31-102-1750-S | In distribution | |
| P31-202-2000-S | In distribution | |
| P31-950-0005 | In distribution | |
| P31-215-3000-S | In distribution | |
| P32-958-0001 | In distribution | |
| P31-901-TRY2 | In distribution | |
| P99-191-TX30-16 | In distribution | |
| P32-959-0110 | In distribution | |
| P31-202-3000-S | In distribution | |
| P31-950-0057 | In distribution | |
| P31-315-250L-S | In distribution | |
| P31-615-175R-S | In distribution | |
| P31-815-300L-S | In distribution | |
| P31-600-175R-S | In distribution | |
| P31-330-175R-S | In distribution | |
| P31-315-300R-S | In distribution | |
| P31-815-350L-S | In distribution | |
| P99-191-TX25-09 | In distribution | |
| P31-300-200R-S | In distribution | |
| P31-400-2500-S | In distribution | |
| P31-958-0001 | In distribution | |
| P31-950-2035 | In distribution | |
| P31-111-0000-03 | In distribution | |
| P31-830-300R-S | In distribution | |
| P31-400-3000-S | In distribution | |
| P31-300-200L-S | In distribution | |
| P31-615-200R-S | In distribution | |
| P31-958-2001 | In distribution | |
| P31-215-2500-S | In distribution | |
| P31-330-150R-S | In distribution | |
| P31-300-250L-S | In distribution | |
| P31-330-200R-S | In distribution | |
| P99-150-2002 | In distribution | |
| P31-630-175R-S | In distribution | |
| P31-630-250R-S | In distribution | |
| P99-191-TX20-16 | In distribution | |
| P31-950-0006 | In distribution | |
| P31-300-250R-S | In distribution | |
| P31-600-175L-S | In distribution | |
| P31-630-175R-S | In distribution | |
| P31-330-250L-S | In distribution | |
| P31-102-2500-S | In distribution | |
| P31-800-200R-S | In distribution | |
| P32-270-1252-S | In distribution | |
| P32-102-0005 | In distribution | |
| P31-115-1750-S | In distribution | |
| P99-191-TX20-09 | In distribution | |
| P31-102-0001 | In distribution | |
| P31-300-200L-S | In distribution | |
| P31-330-175L-S | In distribution | |
| P31-615-200R-S | In distribution | |
| P31-230-2000-S | In distribution | |
| P31-830-200R-S | In distribution | |
| P31-190-TX30-09 | In distribution | |
| P31-415-1500-S | In distribution | |
| P31-950-0003 | In distribution | |
| P31-215-2500-S | In distribution | |
| P31-630-175L-S | In distribution | |
| P31-615-300R-S | In distribution | |
| P31-615-250R-S | In distribution | |
| P31-130-1750-S | In distribution | |
| P31-600-300R-S | In distribution | |
| P31-300-150R-S | In distribution | |
| P31-800-150L-S | In distribution | |
| P31-950-0050 | In distribution | |
| P31-815-150R-S | In distribution | |
| P31-415-2500-S | In distribution | |
| P31-800-250R-S | In distribution | |
| P31-950-9000 | In distribution | |
| P31-615-300L-S | In distribution | |
| P31-830-150R-S | In distribution | |
| P31-630-200R-S | In distribution | |
| P31-415-3000-S | In distribution | |
| P31-950-0009 | In distribution | |
| P31-102-2000-S | In distribution | |
| P31-600-300L-S | In distribution | |
| P31-230-2000-S | In distribution | |
| P31-115-2500-S | In distribution | |
| P31-950-0008 | In distribution | |
| P31-330-250L-S | In distribution | |
| P31-430-1750-S | In distribution | |
| P31-115-1750-S | In distribution | |
| P31-315-250L-S | In distribution | |
| P31-830-300L-S | In distribution | |
| P31-315-200L-S | In distribution | |
| P31-950-1000 | In distribution | |
| P31-315-300R-S | In distribution | |
| P31-615-250L-S | In distribution | |
| P31-330-200R-S | In distribution | |
| P31-130-2000-S | In distribution | |
| P31-202-3000-S | In distribution | |
| P31-950-0007 | In distribution | |
| P31-400-2000-S | In distribution | |
| P31-102-2500-S | In distribution | |
| P31-330-175L-S | In distribution | |
| P32-950-0001 | In distribution | |
| P32-950-0100-L | In distribution | |
| P31-600-175R-S | In distribution | |
| P31-300-250L-S | In distribution | |
| P31-615-250L-S | In distribution | |
| P31-315-150L-S | In distribution | |
| P31-330-250R-S | In distribution | |
| P31-901-LID | In distribution | |
| P31-830-250R-S | In distribution | |
| P31-300-150L-S | In distribution | |
| P31-630-200L-S | In distribution | |
| P31-830-250L-S | In distribution | |
| P32-102-0001 | In distribution | |
| P31-950-2000 | In distribution | |
| P31-830-350L-S | In distribution | |
| P31-111-0000-07 | In distribution | |
| P31-115-2000-S | In distribution | |
| P31-800-250L-S | In distribution | |
| P31-400-1500-S | In distribution | |
| P31-950-0035 | In distribution | |
| P31-102-0005 | In distribution | |
| P99-191-TX25-21 | In distribution | |
| P31-950-0000 | In distribution | |
| P31-615-250R-S | In distribution | |
| P31-215-2000-S | In distribution | |
| P31-300-150L-S | In distribution | |
| P32-270-1408-S | In distribution | |
| P31-330-200L-S | In distribution | |
| P31-300-300L-S | In distribution | |
| P31-901-BASE | In distribution | |
| P31-815-150L-S | In distribution | |
| P31-600-175L-S | In distribution | |
| P31-315-300L-S | In distribution | |
| P31-815-250R-S | In distribution | |
| P31-300-200R-S | In distribution | |
| P31-958-3000 | In distribution | |
| P31-600-250L-S | In distribution | |
| P31-330-200L-S | In distribution | |
| P32-958-2002 | In distribution | |
| P31-102-3000-S | In distribution | |
| P31-111-0000-03 | In distribution | |
| P31-315-150R-S | In distribution | |
| P31-600-250L-S | In distribution | |
| P31-615-175L-S | In distribution | |
| P31-800-300R-S | In distribution | |
| P31-330-150R-S | In distribution | |
| P32-270-1406-S | In distribution | |
| P31-315-150R-S | In distribution | |
| P31-630-250L-S | In distribution | |
| P31-800-300L-S | In distribution | |
| P31-300-250R-S | In distribution | |
| P31-115-2500-S | In distribution | |
| P99-191-PC15-224 | In distribution | |
| P31-330-250R-S | In distribution | |
| P32-270-1404-S | In distribution | |
| P32-270-1402-S | In distribution | |
| P31-815-200R-S | In distribution | |
| P31-100-0005 | In distribution | |
| P31-315-250R-S | In distribution | |
| P32-270-1254-S | In distribution | |
| P31-315-200L-S | In distribution | |
| P31-630-200R-S | In distribution | |
| P32-959-0160 | In distribution | |
| P31-115-2000-S | In distribution | |
| P31-300-300R-S | In distribution | |
| P31-202-2500-S | In distribution | |
| P31-102-0001 | In distribution | |
| P31-130-2500-S | In distribution | |
| P31-815-300R-S | In distribution | |
| P31-202-2000-S | In distribution | |
| P31-615-175L-S | In distribution | |
| P31-615-200L-S | In distribution | |
| P31-315-250R-S | In distribution |
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 |
|---|---|
| K253591 | 2026-03-05 |
| K251850 | 2025-07-14 |
| K234128 | 2024-08-22 |
| K210869 | 2021-06-28 |
| K201227 | 2020-07-17 |
| K192163 | 2020-01-31 |
| K191782 | 2019-09-06 |
| K182307 | 2019-01-14 |
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|
| Paragon 28 | 510(k) number | 2023-12-21 | Class II | Under Investigation by firm | Medical devices distributed, prior to sterilization | |
| Paragon 28 | 510(k) number | 2023-12-21 | Class II | Under Investigation by firm | Medical devices distributed, prior to sterilization | 1 |
| Paragon 28 | 510(k) number | 2023-12-21 | Class II | Under Investigation by firm | Medical devices distributed, prior to sterilization | 1 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2025-10-13 | Class II | Device Design | Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting bolt. If nail (implant | 20 |
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.