Capture™ Screw System
The Capture Screw System is comprised of headless screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and…
The Capture Screw System is comprised of headless screws used for bone fixation of the hand and foot, following trauma or osteotomy. All screws are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The headless screw is a cannulated, dual-thread headless bone screw which is offered in 2.5 and 3.0mm diameters with lengths of 10 → 34mm. The quick snap screw is a snap-off solid screw which is offered in 2.0mm and 2.7mm diameters with lengths of 8-22mm. The system includes instruments to facilitate the placement of the screws.
31manufacturers in China registered for this device type
101catalogue 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 |
|---|---|---|
| AD2046 | 46 mm L x 2 mm dia; 13.5 mm thread | In distribution |
| AC4046 | 1.811 in L x.157 in dia;.60 in thread | In distribution |
| AC3024 | .945 in L x.118 in dia;.32in thread | In distribution |
| AC2020 | .787 in L x.081 in dia;.26 in thread | In distribution |
| AC4020 | .787 in L x.157 in dia;.26 in thread | In distribution |
| AC3014 | .551 in L x.118 in dia;.20 in thread | In distribution |
| AC2010 | .394 in L x.081 in dia;.20 in thread | In distribution |
| AH3018 | .709 in L x.121 in dia;.330 in thread | In distribution |
| AC3020 | .787 in L x.118 in dia;.26 in thread | In distribution |
| AC2528 | 1.102 in L x.098 in dia;.37 in thread | In distribution |
| AD2040 | 40 mm L x 2 mm dia; 12 mm thread | In distribution |
| AQ2720 | 1.654 in L x.107 in dia;.787 in thread | In distribution |
| AH3034 | 1.339 in L x.121 in dia;.650 in thread | In distribution |
| AC2018 | .709 in L x.081 in dia;.24 in thread | In distribution |
| AC2524 | .945 in L x.098 in dia;.32 in thread | In distribution |
| AQ2722 | 1.732 in L x.107 in dia;.866 in thread | In distribution |
| AC2526 | 1.024 in L x.098 in dia;.34 in thread | In distribution |
| AC2510 | .394 in L x.098 in dia;.20 in thread | In distribution |
| AH3016 | .630 in L x.121 in dia;.290 in thread | In distribution |
| AC4040 | 1.575 in L x.157 in dia;.55 in thread | In distribution |
| AQ2714 | 1.417 in L x.107 in dia;.551 in thread | In distribution |
| AC2016 | .630 in L x.081 in dia;.21 in thread | In distribution |
| AC3030 | 1.181 in L x.118 in dia;.39 in thread | In distribution |
| AQ2014 | 1.417 in L x.083 in dia;.551 in thread | In distribution |
| AC3032 | 1.260 in L x.118 in dia;.42 in thread | In distribution |
| AC4018 | .709 in L x.157 in dia;.24 in thread | In distribution |
| AH2516 | .630 in L x.101 in dia;.290 in thread | In distribution |
| AC4042 | 1.654 in L x.157 in dia;.58 in thread | In distribution |
| AH3028 | 1.102 in L x.121 in dia;.530 in thread | In distribution |
| AH3026 | 1.024 in L x.121 in dia;.490 in thread | In distribution |
| AQ2012 | 1.339 in L x.083 in dia;.472 in thread | In distribution |
| AC4014 | .551 in L x.157 in dia;.24 in thread | In distribution |
| AC4016 | .630 in L x.157 in dia;.24 in thread | In distribution |
| AC4022 | .866 in L x.157 in dia;.29 in thread | In distribution |
| AC2014 | .551 in L x.081 in dia;.20 in thread | In distribution |
| AQ2712 | 1.339 in L x.107 in dia;.472 in thread | In distribution |
| AQ2008 | 1.181 in L x.083 in dia;.312 in thread | In distribution |
| AC3010 | .394 in L x.118 in dia;.20 in thread | In distribution |
| AD2028 | 28 mm L x 2 mm dia; 9 mm thread | In distribution |
| AC4034 | 1.339 in L x.157 in dia;.45 in thread | In distribution |
| AC3018 | .709 in L x.118 in dia;.24 in thread | In distribution |
| AH2518 | .709 in L x.101 in dia;.330 in thread | In distribution |
| AC2012 | .472 in L x.081 in dia;.20 in thread | In distribution |
| AC4032 | 1.260 in L x.157 in dia;.42 in thread | In distribution |
| AH2510 | .397 in L x.101 in dia;.170 in thread | In distribution |
| AQ2718 | 1.575 in L x.107 in dia;.709 in thread | In distribution |
| AC4038 | 1.496 in L x.157 in dia;.53 in thread | In distribution |
| AC3016 | .630 in L x.118 in dia;.21 in thread | In distribution |
| AC3022 | .866 in L x.118 in dia;.29 in thread | In distribution |
| AH3024 | .945 in L x.121 in dia;.450 in thread | In distribution |
| AD2036 | 36 mm L x 2 mm dia; 11 mm thread | In distribution |
| AH2514 | .551 in L x.101 in dia;.250 in thread | In distribution |
| AH2522 | .866 in L x.101 in dia;.410 in thread | In distribution |
| AC4012 | .472 in L x.157 in dia;.24 in thread | In distribution |
| AC2516 | .630 in L x.098 in dia;.21 in thread | In distribution |
| AC2520 | .787 in L x.098 in dia;.26 in thread | In distribution |
| AC3034 | 1.339 in L x.118 in dia;.45 in thread | In distribution |
| AD2044 | 44 mm L x 2 mm dia; 13 mm thread | In distribution |
| AC4030 | 1.181 in L x.157 in dia;.39 in thread | In distribution |
| AD2050 | 50 mm L x 2 mm dia; 14.5 mm thread | In distribution |
| AC2508 | .315 in L x.098 in dia;.18 in thread | In distribution |
| AC2514 | .551 in L x.098 in dia;.20 in thread | In distribution |
| AD2038 | 38 mm L x 2 mm dia; 11.5 mm thread | In distribution |
| AC2006 | .236 in L x.081 in dia;.17 in thread | In distribution |
| AD2026 | 26 mm L x 2 mm dia; 8.5 mm thread | In distribution |
| AC3040 | 1.575 in L x.118 in dia;.53 in thread | In distribution |
| AC3028 | 1.102 in L x.118 in dia;.37 in thread | In distribution |
| AH3014 | .551 in L x.121 in dia;.250 in thread | In distribution |
| AD2032 | 32 mm L x 2 mm dia; 10 mm thread | In distribution |
| AH3030 | 1.181 in L x.121 in dia;.570 in thread | In distribution |
| AC2530 | 1.181 in L x.098 in dia;.39 in thread | In distribution |
| AH3020 | .787 in L x.121 in dia;.370 in thread | In distribution |
| AD2048 | 48 mm L x 2 mm dia; 14 mm thread | In distribution |
| AD2030 | 30 mm L x 2 mm dia; 9.5 mm thread | In distribution |
| AQ2011 | 1.299 in L x.083 in dia;.433 in thread | In distribution |
| AQ2010 | 1.260 in L x.083 in dia;.394 in thread | In distribution |
| AC2022 | .866 in L x.081 in dia;.29 in thread | In distribution |
| AQ2016 | 1.496 in L x.083 in dia;.630 in thread | In distribution |
| AC4024 | .945 in L x.157 in dia;.32 in thread | In distribution |
| AQ2716 | 1.496 in L x.107 in dia;.630 in thread | In distribution |
| AH3032 | 1.260 in L x.121 in dia;.610 in thread | In distribution |
| AD2034 | 34 mm L x 2 mm dia; 10.5 mm thread | In distribution |
| AC3026 | 1.024 in L x.118 in dia;.34 in thread | In distribution |
| AH3022 | .866 in L x.121 in dia;.410 in thread | In distribution |
| AC2518 | .709 in L x.098 in dia;.24 in thread | In distribution |
| AD2042 | 42 mm L x 2 mm dia; 12.5 mm thread | In distribution |
| AC3012 | .472 in L x.118 in dia;.20 in thread | In distribution |
| AH2520 | .787 in L x.101 in dia;.370 in thread | In distribution |
| AC2008 | .315 in L x.081 in dia;.18 in thread | In distribution |
| AC2522 | .866 in L x.098 in dia;.29 in thread | In distribution |
| AD2024 | 24 mm L x 2 mm dia; 8 mm thread | In distribution |
| AC4050 | 1.969 in L x.157 in dia;.66 in thread | In distribution |
| AC3036 | 1.417 in L x.118 in dia;.47 in thread | In distribution |
| AC4036 | 1.417 in L x.157 in dia;.47 in thread | In distribution |
| AC4028 | 1.102 in L x.157 in dia;.37 in thread | In distribution |
| AC4026 | 1.024 in L x.157 in dia;.34 in thread | In distribution |
| AH2512 | .472 in L x.101 in dia;.210 in thread | In distribution |
| AC2512 | .472 in L x.098 in dia;.20 in thread | In distribution |
| CAPDIGITIMP | Withdrawn | |
| CAPLOPROIMP | Withdrawn | |
| CAPHLESSIMP | 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.