Capture™ High Torque Screw System
The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping.…
The Capture High-Torque Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel and titanium. The system is intended for fixation of fractures in long bones, fixation of small bones, arthrodesis of the foot, wrist and elbow, and small and long bone osteotomies. This particular system consists of 2.0mm and 3.0mm screws. Instruments are provided to assist with the implants.
31manufacturers in China registered for this device type
108catalogue numbers in this listing
3510(k) clearances naming this product 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 | Ascension Orthopedics, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer |
| 510(k) | K092440 |
| Record published | 2017-10-09 |
| Record revised | 2024-02-19 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Distribution end date | 2026-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CSS50000043012T | .472 in L x.118 in dia;.20 in thread | In distribution |
| CSS50000017090PT | 3.543 in L x.276 in Dia;.63 in Thread | In distribution |
| CSS50000034050T | 1.969 in L x.157 in dia;.66 in thread | In distribution |
| CSS500000640WT | .38 in outer dia x.197 in inner dia x.0394 in H | In distribution |
| CSS500000670WT | .50 in outer dia x.318 in inner dia x.0394 in H | In distribution |
| CSS50000034030T | 1.181 in L x.157 in dia;.39 in thread | In distribution |
| CSS50000043008T | .315 in L x.118 in dia;.20 in thread | In distribution |
| CSS50000034036T | 1.417 in L x.157 in dia;.47 in thread | In distribution |
| CSS50000034032T | 1.260 in L x.157 in dia;.42 in thread | In distribution |
| CSS50000025024T | .944 in L x.197 in dia;.47 in thread | In distribution |
| CSS50000025032T | 1.260 in L x.197 in dia;.47 in thread | In distribution |
| CSS50000025034T | 1.339 in L x.197 in dia;.47 in thread | In distribution |
| CSS500000170115T | 4.528 in L x.276 in Dia; 1.51 in Thread | In distribution |
| CSS50000034044T | 1.732 in L x.157 in dia;.58 in thread | In distribution |
| CSS500000170100T | 3.937 in L x.276 in Dia ; 1.31 in Thread | In distribution |
| CSS50000034046T | 1.811 in L x.157 in dia;.60 in thread | In distribution |
| CSS50000025048T | 1.890 in L x.197 in dia;.63 in thread | In distribution |
| CSS50000052535T | 1.378 in L x.098 in dia;.46 in thread | In distribution |
| CSS50000034038T | 1.496 in L x.157 in dia;.50 in thread | In distribution |
| CSS500000170120T | 4.724 in L x.276 in Dia; 1.58 in Thread | In distribution |
| CSS50000043022T | .866 in L x.118 in dia;.29 in thread | In distribution |
| CSS50000043026T | 1.024 in L x.118 in dia;.34 in thread | In distribution |
| CSS50000052514T | .551 in L x.098 in dia;.20 in thread | In distribution |
| CSS50000017095PT | 3.740 in L x.276 in Dia;.63 in Thread | In distribution |
| CSS50000043014T | .551 in L x.118 in dia;.20 in thread | In distribution |
| CSS50000034018T | .709 in L x.157 in dia;.24 in thread | In distribution |
| CSS50000043040T | 1.575 in L x.118 in dia;.53 in thread | In distribution |
| CSS50000043028T | 1.102 in L x.118 in dia;.37 in thread | In distribution |
| CSS50000017050T | 1.969 in L x.276 in dia;.66 in thread | In distribution |
| CSS50000052518T | .709 in L x.098 in dia;.24 in thread | In distribution |
| CSS50000043018T | .709 in L x.118 in dia;.24 in thread | In distribution |
| CSS50000034048T | 1.890 in L x.157 in dia;.63 in thread | In distribution |
| CSS50000043032T | 1.260 in L x.118 in dia;.42 in thread | In distribution |
| CSS50000017085PT | 3.346 in L x.276 in Dia;.63 in Thread | In distribution |
| CSS50000034040T | 1.575 in L x.157 in dia;.53 in thread | In distribution |
| CSS50000025040T | 1.575 in L x.197 in dia;.52 in thread | In distribution |
| CSS500000170110T | 4.331 in L x.276 in Dia; 1.44 in Thread | In distribution |
| CSS50000017055T | 2.165 in L x.276 in dia;.72 in thread | In distribution |
| CSS50000025026T | 1.024 in L x.197 in dia;.47 in thread | In distribution |
| CSS50000052530T | 1.181 in L x.098 in dia;.39 in thread | In distribution |
| CSS50000034042T | 1.654 in L x.157 in dia;.55 in thread | In distribution |
| CSS500000170115PT | 4.528 in L x.276 in Dia;.63 in Thread | In distribution |
| CSS500000625WT | .25 in outer dia x.116 inner dia x.0394 in H | In distribution |
| CSS50000025042T | 1.654 in L x.197 in dia;.55 in thread | In distribution |
| CSS50000034034T | 1.339 in L x.157 in dia;.45 in thread | In distribution |
| CSS50000025060T | 2.362 in L x.197 in dia;.78 in thread | In distribution |
| CSS50000034016T | .650 in L x.157 in dia;.21 in thread | In distribution |
| CSS50000017080PT | 3.150 in L x.276 in Dia;.63 in Thread | In distribution |
| CSS50000043020T | .787 in L x.118 in dia;.26 in thread | In distribution |
| CSS50000052512T | .472 in L x.098 in dia;.20 in thread | In distribution |
| CSS50000052520T | .787 in L x.098 in dia;.26 in thread | In distribution |
| CSS50000043010T | .394 in L x.118 in dia;.20 in thread | In distribution |
| CSS50000025044T | 1.732 in L x.197 in dia;.57 in thread | In distribution |
| CSS50000025046T | 1.811 in L x.197 in dia;.60 in thread | In distribution |
| CSS50000017085T | 3.346 in L x.276 in dia; 1.12 in thread | In distribution |
| CSS50000017040T | 1.575 in L x.276 in dia;.63 in thread | In distribution |
| CSS50000034055T | 2.165 in L x.157 in dia;.72 in thread | In distribution |
| CSS50000025022T | .866 in L x.197 in dia;.47 in thread | In distribution |
| CSS50000017065T | 2.559 in L x.276 in dia;.85 in thread | In distribution |
| CSS500000170120PT | 4.724 in L x.276 in Dia;.63 in Thread | In distribution |
| CSS50000025036T | 1.417 in L x.197 in dia;.47 in thread | In distribution |
| CSS50000034014T | .551 in L x.157 in dia;.20 in thread | In distribution |
| CSS50000043016T | .630 in L x.118 in dia;.21 in thread | In distribution |
| CSS50000025020T | .787 in L x.197 in dia;.47 in thread | In distribution |
| CSS50000017095T | 3.740 in L x.276 in dia; 1.25 in thread | In distribution |
| CSS50000017080T | 3.150 in L x.276 in dia; 1.05 in thread | In distribution |
| CSS50000034028T | 1.102 in L x.157 in dia;.37 in thread | In distribution |
| CSS50000025065T | 2.559 in L x.197 in dia;.85 in thread | In distribution |
| CSS50000017070T | 2.756 in L x.276 in dia;.92 in thread | In distribution |
| CSS500000650WT | .44 in outer dia x.236 inner dia x.0394 in H | In distribution |
| CSS50000025070T | 2.756 in L x.197 in dia;.91 in thread | In distribution |
| CSS50000043038T | 1.496 in L x.118 in dia;.50 in thread | In distribution |
| CSS50000034024T | .944 in L x.157 in dia;.32 in thread | In distribution |
| CSS50000034022T | .866 in L x.157 in dia;.29 in thread | In distribution |
| CSS50000025030T | 1.181 in L x.197 in dia;.47 in thread | In distribution |
| CSS50000043036T | 1.417 in L x.118 in dia;.47 in thread | In distribution |
| CSS50000034026T | 1.024 in L x.157 in dia;.34 in thread | In distribution |
| CSS50000052524T | .944 in L x.098 in dia;.32 in thread | In distribution |
| CSS500000170105PT | 4.134 in L x.276 in Dia;.63 in Thread | In distribution |
| CSS50000017090T | 3.543 in L x.276 in dia; 1.18 in thread | In distribution |
| CSS50000052510T | .394 in L x.098 in dia;.20 in thread | In distribution |
| CSS50000017045T | 1.772 in L x.276 in dia;.63 in thread | In distribution |
| CSS50000052516T | .630 in L x.098 in dia;.21 in thread | In distribution |
| CSS50000025055T | 2.165 in L x.197 in dia;.72 in thread | In distribution |
| CSS500000170105T | 4.134 in L x.276 in Dia; 1.38 Thread | In distribution |
| CSS50000052526T | 1.024 in L x.098 in dia;.34 in thread | In distribution |
| CSS50000052528T | 1.102 in L x.098 in dia;.37 in thread | In distribution |
| CSS50000034020T | .787 in L x.157 in dia;.26 in thread | In distribution |
| CSS500000630WT | .25 in outer dia x.135 in inner dia x.0394 in H | In distribution |
| CSS50000052508T | .315 in L x.098 in dia;.20 in thread | In distribution |
| CSS500000170100PT | 3.937 in L x.276 in Dia;.63 in Thread | In distribution |
| CSS50000017030T | 1.181 in L x.276 in dia;.63 in thread | In distribution |
| CSS50000052522T | .866 in L x.098 in dia;.29 in thread | In distribution |
| CSS50000043034T | 1.339 in L x.118 in dia;.45 in thread | In distribution |
| CSS50000025028T | 1.102 in L x.197 in dia;.47 in thread | In distribution |
| CSS50000043030T | 1.181 in L x.118 in dia;.39 in thread | In distribution |
| CSS50000017060T | 2.362 in L x.276 in dia;.79 in thread | In distribution |
| CSS50000017035T | 1.378 in L x .276 in dia;.63 in thread | In distribution |
| CSS50000052540T | 1.575 in L x.098 in dia;.53 in thread | In distribution |
| CSS50000034060T | 2.362 in L x.157 in dia;.79 in thread | In distribution |
| CSS50000025038T | 1.496 in L x.197 in dia;.49 in thread | In distribution |
| CSS500000170110PT | 4.331 in L x.276 in Dia;.63 in Thread | In distribution |
| CSS50000043024T | .944 in L x.118 in dia;.32 in thread | In distribution |
| CSS50000017075T | 2.953 in L x.276 in dia;.98 in thread | In distribution |
| CSS50000025050T | 1.969 in L x.197 in dia;.65 in thread | In distribution |
| HITORQ23IMP | Withdrawn | |
| HITORQ7IMP | Withdrawn | |
| HITORQ45IMP | Withdrawn |
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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162153 | 2017-07-14 |
| K152527 | 2015-10-29 |
| K092440 | 2009-11-05 |
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.