Rod, Fixation, Intramedullary and Accessories
LOW Prof Lckng Screw F/IM Nail Ø 5.0MM / L 78MM / XL25/ Ster
17manufacturers in China registered for this device type
715catalogue numbers in this listing
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 | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K172157 |
| Record published | 2018-01-11 |
| Record revised | 2026-02-09 (version 10) |
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 |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 25 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 04.033.179S | In distribution | ||
| 04.033.936S | In distribution | ||
| 04.031.024 | In distribution | ||
| 04.045.030TS | In distribution | ||
| 04.033.043S | In distribution | ||
| 04.003.023 | In distribution | ||
| 04.045.064TS | In distribution | ||
| 04.233.217S | In distribution | ||
| 04.045.060S | In distribution | ||
| 04.025.468S | In distribution | ||
| 04.031.020 | In distribution | ||
| 04.233.237S | In distribution | ||
| 04.233.216S | In distribution | ||
| 04.033.145S | In distribution | ||
| 03.037.024 | In distribution | ||
| 04.003.028 | In distribution | ||
| 04.033.474S | In distribution | ||
| 04.025.590S | In distribution | ||
| 04.033.976S | In distribution | ||
| 04.045.378TS | In distribution | ||
| 04.033.975S | In distribution | ||
| 04.046.670TS | In distribution | ||
| 04.045.885S | In distribution | ||
| 04.233.138S | In distribution | ||
| 04.033.279S | In distribution | ||
| 04.033.931S | In distribution | ||
| 04.033.942S | In distribution | ||
| 04.005.695 | In distribution | ||
| 04.033.240S | In distribution | ||
| 04.033.246S | In distribution | ||
| 04.233.920S | In distribution | ||
| 04.045.328S | In distribution | ||
| 04.033.979S | In distribution | ||
| 04.046.680S | In distribution | ||
| 04.005.412S | In distribution | ||
| 04.033.973S | In distribution | ||
| 04.003.023S | In distribution | ||
| 04.033.436S | In distribution | ||
| 04.046.660S | In distribution | ||
| 456.374S | In distribution | ||
| 04.033.168S | In distribution | ||
| 04.033.443S | In distribution | ||
| 456.641S | In distribution | ||
| 04.033.435S | In distribution | ||
| 04.033.172S | In distribution | ||
| 04.045.380S | In distribution | ||
| 04.045.880S | In distribution | ||
| 04.045.086TS | In distribution | ||
| 03.037.215 | In distribution | ||
| 04.033.928S | In distribution | ||
| 04.025.534S | In distribution | ||
| 04.033.430S | In distribution | ||
| 04.033.965S | In distribution | ||
| 412.110S | In distribution | ||
| 04.033.079S | In distribution | ||
| 04.045.368 | In distribution | ||
| 04.003.036S | In distribution | ||
| 04.033.048S | In distribution | ||
| 04.233.146S | In distribution | ||
| 04.025.536S | In distribution | ||
| 04.033.067S | In distribution | ||
| 04.045.370TS | In distribution | ||
| 04.045.348TS | In distribution | ||
| 04.233.937S | In distribution | ||
| 04.033.069S | In distribution | ||
| 04.045.334 | In distribution | ||
| 04.025.462S | In distribution | ||
| 04.033.047S | In distribution | ||
| 04.033.238S | In distribution | ||
| 456.434S | In distribution | ||
| 456.421S | In distribution | ||
| 04.032.110S | In distribution | ||
| 04.045.034TS | In distribution | ||
| 04.033.235S | In distribution | ||
| 04.033.058S | In distribution | ||
| 04.045.060 | In distribution | ||
| 456.423S | In distribution | ||
| 04.031.032 | In distribution | ||
| 475.915 | In distribution | ||
| 04.033.040S | In distribution | ||
| 412.122 | In distribution | ||
| 04.045.336S | In distribution | ||
| 04.033.143S | In distribution | ||
| 04.033.270S | In distribution | ||
| 04.033.948S | In distribution | ||
| 04.031.026 | In distribution | ||
| 03.033.003 | In distribution | ||
| 04.033.248S | In distribution | ||
| 04.025.528S | In distribution | ||
| 03.037.014 | In distribution | ||
| 04.233.943S | In distribution | ||
| 04.045.030 | In distribution | ||
| 04.046.665S | In distribution | ||
| 04.025.544S | In distribution | ||
| 04.033.075S | In distribution | ||
| 04.045.105S | In distribution | ||
| 04.033.972S | In distribution | ||
| 04.045.390 | In distribution | ||
| 04.033.974S | In distribution | ||
| 04.233.005S | In distribution | ||
| 04.046.710S | In distribution | ||
| 04.233.035S | In distribution | ||
| 04.031.030 | In distribution | ||
| 04.031.023 | In distribution | ||
| 456.379S | In distribution | ||
| 04.045.870S | In distribution | ||
| 456.494S | In distribution | ||
| 04.233.442S | In distribution | ||
| 04.033.438S | In distribution | ||
| 04.033.231S | In distribution | ||
| 04.233.047S | In distribution | ||
| SD03.233.003 | In distribution | ||
| 04.005.452S | In distribution | ||
| 04.233.229S | In distribution | ||
| 04.045.356TS | In distribution | ||
| 04.233.130S | In distribution | ||
| 456.636S | In distribution | ||
| 04.005.693 | In distribution | ||
| 04.033.049S | In distribution | ||
| 04.033.276S | In distribution | ||
| 04.003.027 | In distribution | ||
| 456.456S | In distribution | ||
| 04.033.271S | In distribution | ||
| SD03.037.033 | In distribution | ||
| 456.307 | In distribution | ||
| 04.033.169S | In distribution | ||
| 04.033.937S | In distribution | ||
| 04.033.146S | In distribution | ||
| 04.033.144S | In distribution | ||
| 04.033.944S | In distribution | ||
| 04.045.088 | In distribution | ||
| 04.031.029 | In distribution | ||
| 04.033.938S | In distribution | ||
| 03.037.011 | In distribution | ||
| 04.045.062TS | In distribution | ||
| 04.045.060TS | In distribution | ||
| 04.025.566S | In distribution | ||
| 04.045.058S | In distribution | ||
| 03.033.006 | In distribution | ||
| 04.033.469S | In distribution | ||
| 04.033.467S | In distribution | ||
| 04.003.022 | In distribution | ||
| 04.003.027S | In distribution | ||
| 04.046.715S | In distribution | ||
| 04.033.264S | In distribution | ||
| 04.033.162S | In distribution | ||
| 04.033.968S | In distribution | ||
| 04.045.354 | In distribution | ||
| 456.452S | In distribution | ||
| 04.045.334S | In distribution | ||
| 04.033.161S | In distribution | ||
| 04.233.143S | In distribution | ||
| 456.474S | In distribution | ||
| 04.033.239S | In distribution | ||
| 04.045.380 | In distribution | ||
| 04.003.030S | In distribution | ||
| 04.233.221S | In distribution | ||
| 04.233.932S | In distribution | ||
| 04.031.025 | In distribution | ||
| 04.005.691S | In distribution | ||
| 04.033.177S | In distribution | ||
| 04.045.805S | In distribution | ||
| 04.033.932S | In distribution | ||
| 04.025.422S | In distribution | ||
| 456.327S | In distribution | ||
| 04.033.173S | In distribution | ||
| 60.045.041 | In distribution | ||
| 04.033.473S | In distribution | ||
| 456.425S | In distribution | ||
| 04.005.424S | In distribution | ||
| 04.003.035S | In distribution | ||
| 04.031.035S | In distribution | ||
| 456.477S | In distribution | ||
| 04.033.163S | In distribution | ||
| 04.033.171S | In distribution | ||
| 04.233.947S | In distribution | ||
| 04.032.105S | In distribution | ||
| 04.033.441S | In distribution | ||
| 04.025.434S | In distribution | ||
| 04.025.540S | In distribution | ||
| 456.315S | In distribution | ||
| 04.033.434S | In distribution | ||
| 04.031.024S | In distribution | ||
| 04.005.695S | In distribution | ||
| 04.005.416S | In distribution | ||
| 04.005.693S | In distribution | ||
| 04.033.449S | In distribution | ||
| 04.045.074TS | In distribution | ||
| 275.925 | In distribution | ||
| 04.045.070 | In distribution | ||
| 04.033.946S | In distribution | ||
| 04.033.234S | In distribution | ||
| 04.045.110TS | In distribution | ||
| 04.033.263S | In distribution | ||
| 04.033.464S | In distribution | ||
| 04.033.064S | In distribution | ||
| 04.033.059S | In distribution | ||
| 04.031.029S | In distribution | ||
| 04.045.374S | In distribution | ||
| 04.025.416S | In distribution | ||
| 456.313S | In distribution | ||
| 04.033.463S | In distribution | ||
| 04.045.358TS | In distribution | ||
| 04.033.432S | In distribution | ||
| 04.233.147S | In distribution | ||
| 04.045.084 | In distribution | ||
| 04.003.033S | In distribution | ||
| 04.025.470S | In distribution | ||
| 456.407S | In distribution | ||
| 04.033.945S | In distribution | ||
| 04.045.384 | In distribution | ||
| 04.033.149S | In distribution | ||
| 04.003.034 | In distribution | ||
| 04.033.929S | In distribution | ||
| 04.045.332 | In distribution | ||
| 04.003.025 | In distribution | ||
| 04.033.060S | In distribution | ||
| 04.233.140S | In distribution | ||
| 04.045.390TS | In distribution | ||
| 04.005.414 | In distribution | ||
| 04.033.233S | In distribution | ||
| 04.033.262S | In distribution | ||
| 04.031.028 | In distribution | ||
| 03.233.005 | In distribution | ||
| 03.033.002 | In distribution | ||
| 04.045.100TS | In distribution | ||
| 04.025.556S | In distribution | ||
| 04.045.115S | In distribution | ||
| 04.045.082S | In distribution | ||
| 04.033.030S | In distribution | ||
| 04.033.178S | In distribution | ||
| 04.031.025S | In distribution | ||
| 04.033.934S | In distribution | ||
| 04.025.568S | In distribution | ||
| 04.033.165S | In distribution | ||
| 456.633S | In distribution | ||
| 04.025.532S | In distribution | ||
| 04.233.446S | In distribution | ||
| 04.045.875S | In distribution | ||
| 04.045.062S | In distribution | ||
| 04.033.958S | In distribution | ||
| 04.033.245S | In distribution | ||
| 04.033.142S | In distribution | ||
| 04.033.447S | In distribution | ||
| 04.045.115TS | In distribution | ||
| 456.643S | In distribution | ||
| 04.045.026 | In distribution | ||
| 03.037.012 | In distribution | ||
| 08.025.044S | 2 | In distribution | |
| 456.302 | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Precice® Bone Transport System | NuVasive Specialized Orthopedics, Inc. | 546 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
Recalls Naming This Product
24 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 |
|---|---|---|---|---|---|---|---|
| Synthes (USA) Products LLC | 510(k) number | 2025-09-26 | Class II | Process control | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. | 120 units | |
| Synthes (USA) Products LLC | 510(k) number | 2025-09-26 | Class II | Process control | Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm. | 122 units | |
| Synthes (USA) Products LLC | 510(k) number | 2024-01-24 | Class II | Process control | Products not sterilized, sterility cannot be confirmed | 5 units | |
| Synthes (USA) Products LLC | 510(k) number | 2024-01-24 | Class II | Process control | Products not sterilized, sterility cannot be confirmed | 11 units | |
| Synthes (USA) Products LLC | 510(k) number | 2024-01-24 | Class II | Process control | Products not sterilized, sterility cannot be confirmed | 11 units | |
| Synthes (USA) Products LLC | 510(k) number | 2023-02-01 | Class II | Under Investigation by firm | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length | 6 units | |
| Synthes (USA) Products LLC | 510(k) number | 2023-02-01 | Class II | Under Investigation by firm | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length | 5 units | |
| Synthes (USA) Products LLC | 510(k) number | 2023-02-01 | Class II | Under Investigation by firm | TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length | 6 units | |
| Synthes (USA) Products LLC | 510(k) number | 2017-07-21 | Class II | Employee error | The locking mechanism and protective cap were missing from the sterile packed nails of the affected lot. | 4 units | 2018-07-10 |
| Synthes (USA) Products LLC | 510(k) number | 2015-11-02 | Class II | Process control | TFNA nails may have the locking mechanism too close to the top of the nail. This may 1. Prevent the cannulated connecting screw from fully tightening the insertion handle to the nail resulting in a loose or toggling nail in the handle. Or | 5 | 2016-05-13 |
| Synthes (USA) Products LLC | 510(k) number | 2015-09-21 | Class II | Device Design | Certain lots of the Screw Inserter may be etched with incorrect graphics. The orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument. | 793 | 2016-08-26 |
| Synthes (USA) Products LLC | 510(k) number | 2015-06-10 | Class II | Process control | The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017). | 32 | 2016-08-18 |
| Synthes Gmbh | 510(k) number | 2015-05-27 | Class II | Process control | certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Compo | 276 | 2015-12-18 |
| Synthes Gmbh | 510(k) number | 2015-04-09 | Class II | Process control | TFNA nails from certain lots were assembled with a locking mechanism too close to the top of the nail. Potential patient impact: surgical delay. | 8175 | 2016-08-18 |
| Synthes Gmbh | 510(k) number | 2015-02-24 | Class II | Component design/selection | The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and removal of instruments. | 131 | 2015-09-21 |
| Synthes Gmbh | 510(k) number | 2014-10-29 | Class II | Employee error | The 10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM (Sterile) was assembled incorrectly. If the non conformance goes undetected, it may impact the locking function post-operatively and compromise the bone reduction an | 6 | 2015-12-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-10-03 | Class II | Process control | A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blades to be distributed. | 350195 | 2016-08-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-07-31 | Class II | Process control | The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck. | 135 | 2015-06-01 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-07-30 | Class II | Nonconforming Material/Component | Two lots of Titanium Trochanteric Fixation Nail (TFN) System are missing the second bend in the nail. | 17 | 2015-09-10 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-07-30 | Class II | Employee error | Certain lots of Trochanteric Fixation Nail were distributed to the field with the incorrect labeling of the length and diameter of the nail on the packaging. | 12 | 2015-09-10 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-04-18 | Class II | Packaging process control | Firm discovered that a nail that was within the scope of a previous Trauma Nail recall had been distributed. | 1 | 2015-03-30 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-11-02 | Class II | Packaging change control | Recall was initiated due to the possibility that the outer pouch was compromised. The product is packaged in two pouches; a sterile, internal pouch within an external pouch. It is the outer, external pouch that may be compromised. | 1,011,783 | 2016-09-27 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-05-22 | Class II | Error in labeling | Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. | 20 | 2015-09-10 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-05-22 | Class II | Error in labeling | Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. | 20 | 2015-09-10 |
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.