VA-LCP
TI 2.4MM VA LCP 2-COL Dstl RAD PL NRW 6HH/3HS/RT KIT-Sterile
31manufacturers in China registered for this device type
390catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Synthes Gmbh, Switzerland |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K012114 |
| Record published | 2017-04-06 |
| Record revised | 2025-11-20 (version 12) |
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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 04.111.530KS | In distribution | |
| 02.127.321S | In distribution | |
| 02.107.412 | In distribution | |
| 02.118.410S | In distribution | |
| 04.211.261S | In distribution | |
| 04.211.250 | In distribution | |
| 04.111.631KS | In distribution | |
| 02.211.256 | In distribution | |
| 04.107.208S | In distribution | |
| 02.117.708S | In distribution | |
| 02.211.234S | In distribution | |
| 02.127.210S | In distribution | |
| 03.117.702 | In distribution | |
| 02.124.412 | In distribution | |
| 04.111.550 | In distribution | |
| 04.117.604S | In distribution | |
| 02.118.215S | In distribution | |
| 04.112.046 | In distribution | |
| 03.107.204 | In distribution | |
| 04.111.550S | In distribution | |
| 02.127.240S | In distribution | |
| 04.211.266 | In distribution | |
| 04.111.731KS | In distribution | |
| 04.117.004S | In distribution | |
| 04.211.257 | In distribution | |
| 04.211.255 | In distribution | |
| 04.107.408S | In distribution | |
| 03.127.011 | In distribution | |
| 02.117.213S | In distribution | |
| 02.111.530 | In distribution | |
| 02.118.210 | In distribution | |
| 02.211.240S | In distribution | |
| 02.107.302 | In distribution | |
| 02.117.111S | In distribution | |
| 02.127.211 | In distribution | |
| 02.117.307S | In distribution | |
| 04.118.416 | In distribution | |
| 02.107.306 | In distribution | |
| 02.211.265 | In distribution | |
| 02.211.255 | In distribution | |
| 02.118.303S | In distribution | |
| 03.115.750 | In distribution | |
| 04.112.048S | In distribution | |
| 02.118.402 | In distribution | |
| 02.127.251S | In distribution | |
| 02.107.508 | In distribution | |
| 04.211.240 | In distribution | |
| 04.118.412S | In distribution | |
| 02.211.230 | In distribution | |
| 02.118.208 | In distribution | |
| 02.118.106S | In distribution | |
| 04.118.403 | In distribution | |
| 02.118.414S | In distribution | |
| 02.124.411 | In distribution | |
| 03.115.851 | In distribution | |
| 04.211.259S | In distribution | |
| 04.117.309 | In distribution | |
| 02.127.351 | In distribution | |
| 02.127.260 | In distribution | |
| 04.211.240S | In distribution | |
| 02.211.251S | In distribution | |
| 02.118.303 | In distribution | |
| 02.107.002S | In distribution | |
| 02.124.414S | In distribution | |
| 02.127.361 | In distribution | |
| 04.117.501 | In distribution | |
| 02.112.049S | In distribution | |
| 04.118.413 | In distribution | |
| 04.211.251S | In distribution | |
| 02.112.049 | In distribution | |
| 02.211.232S | In distribution | |
| 02.111.530KS | In distribution | |
| 02.118.213 | In distribution | |
| 02.117.309S | In distribution | |
| 02.118.213S | In distribution | |
| 02.107.206 | In distribution | |
| 04.117.704S | In distribution | |
| 02.211.420S | In distribution | |
| 02.107.202 | In distribution | |
| 03.107.002 | In distribution | |
| 02.117.704 | In distribution | |
| 02.118.110S | In distribution | |
| 02.127.311S | In distribution | |
| 04.117.506S | In distribution | |
| 04.117.809S | In distribution | |
| 02.127.320 | In distribution | |
| 02.124.406 | In distribution | |
| 02.117.909S | In distribution | |
| 02.211.245 | In distribution | |
| 04.107.510S | In distribution | |
| 04.211.246 | In distribution | |
| 02.117.608S | In distribution | |
| 04.107.410 | In distribution | |
| 04.107.102 | In distribution | |
| 04.118.414 | In distribution | |
| 02.118.011 | In distribution | |
| 02.112.046S | In distribution | |
| 04.117.502 | In distribution | |
| 04.117.111S | In distribution | |
| 04.117.406 | In distribution | |
| 04.211.265 | In distribution | |
| 03.107.102 | In distribution | |
| 02.107.308S | In distribution | |
| 03.118.106 | In distribution | |
| 04.117.805 | In distribution | |
| 04.115.851 | In distribution | |
| 02.107.102S | In distribution | |
| 02.127.331S | In distribution | |
| 04.117.702S | In distribution | |
| 02.111.551 | In distribution | |
| 04.117.606 | In distribution | |
| 04.211.230S | In distribution | |
| 04.211.247 | In distribution | |
| 02.115.851 | In distribution | |
| 04.211.237S | In distribution | |
| 03.231.003 | In distribution | |
| 02.118.400 | In distribution | |
| 02.127.261S | In distribution | |
| 02.211.417 | In distribution | |
| 04.117.902S | In distribution | |
| 04.211.232 | In distribution | |
| 02.117.807S | In distribution | |
| 04.117.602S | In distribution | |
| 02.127.310 | In distribution | |
| 04.107.408 | In distribution | |
| 04.117.211S | In distribution | |
| 02.112.045 | In distribution | |
| 02.124.409 | In distribution | |
| 02.117.109 | In distribution | |
| 02.211.261S | In distribution | |
| 04.115.751S | In distribution | |
| 02.211.417S | In distribution | |
| 02.118.407 | In distribution | |
| 04.117.103 | In distribution | |
| 02.118.203 | In distribution | |
| 02.127.241S | In distribution | |
| 02.127.220 | In distribution | |
| 04.118.417 | In distribution | |
| 04.211.252 | In distribution | |
| 02.117.802 | In distribution | |
| 02.117.510S | In distribution | |
| 02.118.008 | In distribution | |
| 02.107.304S | In distribution | |
| 04.117.406S | In distribution | |
| 04.107.508 | In distribution | |
| 04.211.243 | In distribution | |
| 02.127.320S | In distribution | |
| 02.118.210S | In distribution | |
| 02.127.230 | In distribution | |
| 04.107.204S | In distribution | |
| 02.107.102 | In distribution | |
| 02.211.416 | In distribution | |
| 04.117.402 | In distribution | |
| 04.118.405S | In distribution | |
| 02.117.907S | In distribution | |
| 04.118.407 | In distribution | |
| 02.118.410 | In distribution | |
| 02.211.257 | In distribution | |
| 04.117.404 | In distribution | |
| 04.107.204 | In distribution | |
| 02.115.851S | In distribution | |
| 02.118.014S | In distribution | |
| 02.124.421S | In distribution | |
| 03.115.800 | In distribution | |
| 02.127.230S | In distribution | |
| 02.118.107S | In distribution | |
| 02.127.231 | In distribution | |
| 03.127.008 | In distribution | |
| 04.211.236 | In distribution | |
| 02.124.407S | In distribution | |
| 04.112.045S | In distribution | |
| 02.117.103S | In distribution | |
| 02.112.046 | In distribution | |
| 02.111.520 | In distribution | |
| 04.117.004 | In distribution | |
| 02.107.208S | In distribution | |
| 02.118.417 | In distribution | |
| 02.118.401S | In distribution | |
| 02.111.630KS | In distribution | |
| 02.118.412 | In distribution | |
| 02.211.233S | In distribution | |
| 04.117.701 | In distribution | |
| 02.118.212 | In distribution | |
| 02.124.414 | In distribution | |
| 02.117.007S | In distribution | |
| 02.118.115S | In distribution | |
| 02.117.809S | In distribution | |
| 04.107.506S | In distribution | |
| 02.111.521 | In distribution | |
| 02.118.002S | In distribution | |
| 02.118.406S | In distribution | |
| 02.118.104S | In distribution | |
| 02.107.506 | In distribution | |
| 02.118.217 | In distribution | |
| 02.127.341 | In distribution | |
| 02.118.216S | In distribution | |
| 04.211.233 | In distribution | |
| 02.117.606 | In distribution | |
| 02.127.350S | In distribution | |
| 02.117.701 | In distribution | |
| 04.211.254S | In distribution | |
| 04.117.702 | In distribution | |
| 02.112.045S | In distribution | |
| 02.211.240 | In distribution | |
| 02.117.003S | In distribution | |
| 04.107.302 | In distribution | |
| 02.107.408S | In distribution | |
| 04.111.540 | In distribution | |
| 02.211.241 | In distribution | |
| 04.211.244S | In distribution | |
| 04.118.401S | In distribution | |
| 04.117.710S | In distribution | |
| 02.117.602S | In distribution | |
| 04.211.236S | In distribution | |
| 02.118.203S | In distribution | |
| 03.115.751 | In distribution | |
| 03.118.107 | In distribution | |
| 02.118.011S | In distribution | |
| 04.211.257S | In distribution | |
| 02.117.601 | In distribution | |
| 02.118.413S | In distribution | |
| 02.117.107 | In distribution | |
| 04.211.239 | In distribution | |
| 04.211.231S | In distribution | |
| 02.127.341S | In distribution | |
| 04.118.408S | In distribution | |
| 02.118.114S | In distribution | |
| 02.117.211S | In distribution | |
| 04.117.606S | In distribution | |
| 04.107.304S | In distribution | |
| 02.211.233 | In distribution | |
| 02.117.009 | In distribution | |
| 02.118.406 | In distribution | |
| 04.211.233S | In distribution | |
| 02.124.417 | In distribution | |
| 04.118.408 | In distribution | |
| 04.111.521 | In distribution | |
| 04.117.902 | In distribution | |
| 02.117.401S | In distribution | |
| 02.118.211S | In distribution | |
| 04.117.811S | In distribution | |
| 04.211.241S | In distribution | |
| 04.211.234S | In distribution | |
| 02.127.231S | In distribution | |
| 02.111.541S | In distribution | |
| 02.117.602 | In distribution | |
| 02.112.047S | In distribution | |
| 02.117.304S | In distribution | |
| 02.118.111S | In distribution | |
| 04.118.416S | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
Recalls Naming This Product
8 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 | 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 | 2015-09-28 | Class II | Labeling mix-ups | The 2.7MM/3.5MM VA-LCP Humerus Plates were found to be labeled incorrectly. Part number 02.117.410S was incorrectly etched with part number 02.117.610S | 36 | 2016-12-06 |
| Synthes Gmbh | 510(k) number | 2014-02-05 | Class II | Employee error | Labeling correction: The package insert in one 5.0mm Variable Locking Screw package was a GP0006 (Anterior Cervical Vertebrae Plate System) insert, which should have been a GP2848 (4.5mm VA-LCP Curved Condylar Plate System insert). | 45 | 2015-08-31 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-07-30 | Class II | Process control | The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are etched with “R” for right plate when they should be etched with “L” for left plate. | 11 | 2015-05-21 |
| Synthes (USA) Products LLC | 510(k) number | 2013-05-31 | Class II | Device Design | The firm is initiating a Field Safety Correction for the labeling of the 2.4mm VA-LCP Two Column Volar Distal Radius Plate and 1.2 Nm Torque Limiting Attachment. The US Technique guide lists 1.2Nm TLA as an option for use with the 2.4mm Var | 119, 891 | 2015-09-21 |
| Synthes USA (HQ), Inc. | 510(k) number | 2013-05-29 | Class II | Employee error | A plate was inadvertently released to a sales consultant that was restricted for sale. | 1 | 2015-05-21 |
| Synthes Gmbh | 510(k) number | 2006-12-05 | Not classified | Other | Hole is malformed, leading to reduced construct strength. | 11 units | 2007-02-13 |
Recalls
3 of these are 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 | Closed |
|---|---|---|---|---|---|
| 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 |
| 2014-06-30 | Class II | Employee error | A screw set was returned from the field for destruction after being exposed to flood water, which was erroneously reprocessed and returned to the field. Initial investigative testing indicated the components within the set may be cytotoxic. | 4 | 2015-12-18 |
| 2014-05-15 | Class II | Labeling design | All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label. | 44 | 2015-12-18 |
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.