Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
5.0MM TI Locking SCR SLF-Tpng With T25 Stardrive Recess 40MM
17manufacturers in China registered for this device type
880catalogue numbers in this listing
1510(k) clearance
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Zhejiang (3). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | KTT |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K000684 |
| Record published | 2015-09-14 |
| Record revised | 2025-11-20 (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 |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2024-11-07 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 213.020 | In distribution | ||
| 413.045 | In distribution | ||
| 212.214 | In distribution | ||
| 294.950 | In distribution | ||
| 02.172.635S | In distribution | ||
| 294.76SHA | In distribution | ||
| 416.045 | In distribution | ||
| 212.204 | In distribution | ||
| 413.032 | In distribution | ||
| 412.212S | In distribution | ||
| 293.840 | In distribution | ||
| 414.885 | In distribution | ||
| 418.045 | In distribution | ||
| 218.055 | In distribution | ||
| 04.168.110S | In distribution | ||
| 03.311.115 | In distribution | ||
| 214.915 | In distribution | ||
| 294.71 | In distribution | ||
| 02.240.210 | In distribution | ||
| 03.311.344 | In distribution | ||
| SD03.168.018 | In distribution | ||
| 03.311.846 | In distribution | ||
| 212.103 | In distribution | ||
| 394.84 | In distribution | ||
| 390.012 | In distribution | ||
| 417.085 | In distribution | ||
| 418.040 | In distribution | ||
| 390.033 | In distribution | ||
| 412.214 | In distribution | ||
| 395.109 | In distribution | ||
| 413.040 | In distribution | ||
| 414.828 | In distribution | ||
| 02.152.435 | In distribution | ||
| 04.268.000S | In distribution | ||
| 02.240.295 | In distribution | ||
| 395.111 | In distribution | ||
| 03.311.012 | In distribution | ||
| 214.022 | In distribution | ||
| 294.776 | In distribution | ||
| 394.81 | In distribution | ||
| 217.095 | In distribution | ||
| 217.090 | In distribution | ||
| 414.915 | In distribution | ||
| 03.311.948 | In distribution | ||
| 390.036 | In distribution | ||
| 293.83 | In distribution | ||
| 03.311.202 | In distribution | ||
| 294.53 | In distribution | ||
| 02.240.085 | In distribution | ||
| 395.58 | In distribution | ||
| 03.311.324 | In distribution | ||
| 390.041 | In distribution | ||
| 412.108 | In distribution | ||
| 03.301.010S | In distribution | ||
| 03.311.910 | In distribution | ||
| 412.221S | In distribution | ||
| 402.250 | In distribution | ||
| 02.152.460SHA | In distribution | ||
| 04.150.435S | In distribution | ||
| 494.774 | In distribution | ||
| 417.065 | In distribution | ||
| 394.793 | In distribution | ||
| 214.844 | In distribution | ||
| 03.311.814 | In distribution | ||
| 216.105 | In distribution | ||
| 390.031 | In distribution | ||
| 04.168.320S | In distribution | ||
| 213.030 | In distribution | ||
| 412.217S | In distribution | ||
| 02.212.058 | In distribution | ||
| 03.311.230 | In distribution | ||
| 03.311.946 | In distribution | ||
| 03.311.318 | In distribution | ||
| 04.168.520S | In distribution | ||
| 282.241 | In distribution | ||
| 413.365 | In distribution | ||
| 294.43 | In distribution | ||
| 03.311.970 | In distribution | ||
| 213.465 | In distribution | ||
| 03.301.013S | In distribution | ||
| 412.214S | In distribution | ||
| 395.57 | In distribution | ||
| 02.240.254 | In distribution | ||
| 217.055 | In distribution | ||
| 03.311.175 | In distribution | ||
| 413.360 | In distribution | ||
| 412.205 | In distribution | ||
| 02.240.056 | In distribution | ||
| 282.235 | In distribution | ||
| 03.311.450 | In distribution | ||
| 414.858 | In distribution | ||
| 293.50 | In distribution | ||
| 294.784 | In distribution | ||
| 214.016 | In distribution | ||
| 395.792 | In distribution | ||
| 412.216 | In distribution | ||
| 02.152.415SHA | In distribution | ||
| 245.036 | In distribution | ||
| 218.110 | In distribution | ||
| 417.090 | In distribution | ||
| 412.111S | In distribution | ||
| 416.035 | In distribution | ||
| 414.822 | In distribution | ||
| 412.121 | In distribution | ||
| 293.62 | In distribution | ||
| 294.76 | In distribution | ||
| 04.168.315S | In distribution | ||
| 413.038 | In distribution | ||
| 04.170.640SHA | In distribution | ||
| 02.250.640SHA | In distribution | ||
| 216.070 | In distribution | ||
| 412.209 | In distribution | ||
| 413.338 | In distribution | ||
| 04.168.085S | In distribution | ||
| 03.311.055 | In distribution | ||
| 294.65 | In distribution | ||
| 413.350 | In distribution | ||
| 416.075 | In distribution | ||
| 216.040 | In distribution | ||
| 245.024 | In distribution | ||
| 282.240 | In distribution | ||
| 245.912 | In distribution | ||
| 02.240.095 | In distribution | ||
| 02.212.056 | In distribution | ||
| 02.152.440S | In distribution | ||
| 04.252.670 | In distribution | ||
| 412.124 | In distribution | ||
| 02.240.010 | In distribution | ||
| 494.792 | In distribution | ||
| 294.54SHA | In distribution | ||
| 03.311.308 | In distribution | ||
| 04.168.480S | In distribution | ||
| 412.112S | In distribution | ||
| 217.135 | In distribution | ||
| 217.130 | In distribution | ||
| 04.170.540 | In distribution | ||
| 413.328 | In distribution | ||
| 03.311.968 | In distribution | ||
| 282.243 | In distribution | ||
| 394.798 | In distribution | ||
| 02.240.222 | In distribution | ||
| 04.150.450 | In distribution | ||
| 217.060 | In distribution | ||
| 294.795 | In distribution | ||
| 202.234 | In distribution | ||
| 392.961 | In distribution | ||
| 394.791 | In distribution | ||
| 03.311.061.10 | 10 | In distribution | |
| 494.786SHA | In distribution | ||
| 390.002 | In distribution | ||
| 393.737 | In distribution | ||
| 395.797 | In distribution | ||
| 294.775 | In distribution | ||
| 294.794SHA | In distribution | ||
| 03.311.396 | In distribution | ||
| 02.240.048 | In distribution | ||
| 03.311.082 | In distribution | ||
| 03.311.310 | In distribution | ||
| 03.311.204 | In distribution | ||
| 03.311.892 | In distribution | ||
| 214.920 | In distribution | ||
| 02.240.258 | In distribution | ||
| 02.250.670S | In distribution | ||
| 02.170.530SHA | In distribution | ||
| 417.075 | In distribution | ||
| 418.035 | In distribution | ||
| 394.799 | In distribution | ||
| 412.224 | In distribution | ||
| 417.150 | In distribution | ||
| 02.240.022 | In distribution | ||
| 293.74 | In distribution | ||
| 04.168.505S | In distribution | ||
| 02.240.065 | In distribution | ||
| 214.064 | In distribution | ||
| 294.75SHA | In distribution | ||
| 414.830 | In distribution | ||
| 212.221 | In distribution | ||
| 412.211 | In distribution | ||
| 245.035 | In distribution | ||
| 282.237 | In distribution | ||
| 214.085 | In distribution | ||
| 04.252.685SHA | In distribution | ||
| 294.68SHA | In distribution | ||
| 03.312.840 | In distribution | ||
| 202.238 | In distribution | ||
| 03.311.988 | In distribution | ||
| 212.118 | In distribution | ||
| 04.168.105S | In distribution | ||
| 213.036 | In distribution | ||
| 02.240.024 | In distribution | ||
| 245.914 | In distribution | ||
| 412.101 | In distribution | ||
| 214.842 | In distribution | ||
| 294.44SHA | In distribution | ||
| 294.794 | In distribution | ||
| 414.850 | In distribution | ||
| 03.311.022 | In distribution | ||
| 03.311.311 | In distribution | ||
| 214.854 | In distribution | ||
| 214.046 | In distribution | ||
| 412.222 | In distribution | ||
| 416.110 | In distribution | ||
| 03.311.174 | In distribution | ||
| 213.034 | In distribution | ||
| 03.311.048 | In distribution | ||
| 04.250.570 | In distribution | ||
| 02.240.052 | In distribution | ||
| 218.040 | In distribution | ||
| 213.045 | In distribution | ||
| 212.124 | In distribution | ||
| 02.252.570S | In distribution | ||
| 394.97 | 10 | In distribution | |
| 418.050 | In distribution | ||
| 294.793SHA | In distribution | ||
| 413.426 | In distribution | ||
| 03.311.010 | In distribution | ||
| 293.63 | In distribution | ||
| 294.72 | In distribution | ||
| 412.117 | In distribution | ||
| 402.260 | In distribution | ||
| 395.788 | In distribution | ||
| 402.246 | In distribution | ||
| 412.221 | In distribution | ||
| 214.864 | In distribution | ||
| 394.050 | In distribution | ||
| 416.055 | In distribution | ||
| 03.311.844 | In distribution | ||
| 245.884 | In distribution | ||
| 214.032 | In distribution | ||
| 02.240.050 | In distribution | ||
| 02.252.655 | In distribution | ||
| 03.168.009 | In distribution | ||
| 412.223 | In distribution | ||
| 03.311.060 | In distribution | ||
| 418.085 | In distribution | ||
| 412.210S | In distribution | ||
| 390.029 | In distribution | ||
| 245.033 | In distribution | ||
| 412.215 | In distribution | ||
| 294.793 | In distribution | ||
| 04.250.570SHA | In distribution | ||
| 02.170.625SHA | In distribution | ||
| 213.418 | In distribution | ||
| 294.73SHA | In distribution | ||
| 390.027 | In distribution | ||
| 412.130 | In distribution | ||
| 214.125 | In distribution | ||
| 02.252.585SHA | In distribution | ||
| 294.783SHA | In distribution | ||
| 03.311.032 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Correction | Wishbone Medical Inc. | 1,534 |
| LCP | Synthes Gmbh | 355 |
| Orthex External Fixation System | Orthopediatrics, Corp | 353 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Sterilmed, Inc. | 325 |
| CHS | Smith & Nephew, Inc. | 321 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker Sustainability Solutions | 277 |
| Hoffmann | Stryker GmbH | 239 |
| Orthex | Orthopediatrics, Corp | 231 |
| Orthex | Vilex IN Tennessee, Inc. | 221 |
| Omega | Stryker GmbH | 212 |
| eZ-Fix | Orthopediatrics, Corp | 207 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Smith & Nephew, Inc. | 204 |
Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K122455 | 2013-04-11 |
Recalls Naming This Product
18 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 |
|---|---|---|---|---|---|---|---|
| Microport Orthopedics Inc. | 510(k) number | 2017-09-18 | Class II | Packaging process control | The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infec | 48 units | 2021-04-08 |
| Synthes (USA) Products LLC | 510(k) number | 2016-06-28 | Class II | Nonconforming Material/Component | It was reported that the specified lots of the 2.4mm Titanium Locking Screw Self-Tapping with Stardrive Recess 12mm can break between the head and the shaft. This resulted from the neck feature being too close to the StarDrive feature leav | 41 units | 2017-02-02 |
| Synthes (USA) Products LLC | 510(k) number | 2015-11-02 | Class II | Process control | It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP | 229 | 2016-07-15 |
| Synthes (USA) Products LLC | 510(k) number | 2015-10-06 | Class II | Packaging | Specific lots of the SS 2.7mm locking screw have been mislabeled as SS 2.4mm locking screw. | 98 | 2016-07-15 |
| Synthes (USA) Products LLC | 510(k) number | 2015-07-29 | Class II | Labeling design | Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR | 5306080 | 2016-09-27 |
| Synthes Gmbh | 510(k) number | 2015-05-13 | Class II | Employee error | Certain lots of the 3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws were found to have been labeled incorrectly. | 54 | 2016-08-18 |
| Synthes Gmbh | 510(k) number | 2014-10-17 | Class II | Labeling design | Under new testing protocols for MR Environment safety and compatibility, metal devices are no longer designated MR Safe. Some components in the CMF Mandible External Fixator Systems were labeled and/or etched with information indicating the | 43159 | 2016-08-18 |
| Synthes Gmbh | 510(k) number | 2014-04-10 | Class II | Labeling Change Control | Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe. | 5,114,052 | 2016-08-26 |
| Synthes Gmbh | 510(k) number | 2014-01-07 | Class II | Component design/selection | The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, or breaking of the screw connecting the Saw Guide to the Drill Template or jamming, bending, or breaking of the K-wire during fixation of the D | 343 | 2015-09-10 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-10-09 | Class II | Labeling False and Misleading | A labeling correction was initiated related to the Surgical Technique Guide J5606-C “TomoFix Osteotomy System” due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is no | 2912 | 2015-12-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-07-31 | Class II | Labeling mix-ups | Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issue. The SS 2.7mm Screw was labeled as SS 2.4 mm Screw. | 98 | 2016-08-18 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-03-08 | Class II | Labeling mix-ups | Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276). | 2 | 2015-05-21 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-01-11 | Class II | Nonconforming Material/Component | The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts. | 136 | 2015-08-31 |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-10-12 | Class II | Packaging | It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect in | 8 | |
| Synthes USA (HQ), Inc. | 510(k) number | 2012-09-28 | Class II | Labeling mix-ups | The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect. | 8 | 2015-09-21 |
| 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 |
| Synthes Spine | 510(k) number | 2009-02-09 | Not classified | Process control | Numbers are etched incorrectly on the product. | 1,137 units | 2009-12-15 |
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.