Total Foot System 2
Rear Foot Reconstruction Plate. 54MM. 9 Holes
31manufacturers in China registered for this device type
85catalogue numbers in this listing
27510(k) clearances naming this product code
36recalls 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 | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K100502 |
| Record published | 2022-12-21 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: : – |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2837130 | In distribution | |
| 2806206 | In distribution | |
| 2803009 | In distribution | |
| 2835020 | In distribution | |
| 2802014 | In distribution | |
| 2832104 | In distribution | |
| 2801104 | In distribution | |
| 2837116 | In distribution | |
| 2837140 | In distribution | |
| 2802030 | In distribution | |
| 2822108 | In distribution | |
| 2845130 | In distribution | |
| 2835012 | In distribution | |
| 2837150 | In distribution | |
| 2801230 | In distribution | |
| 2822118 | In distribution | |
| 2845145 | In distribution | |
| 2845132 | In distribution | |
| 2830028 | In distribution | |
| 2803007 | In distribution | |
| 2808004 | In distribution | |
| 2822110 | In distribution | |
| 2835026 | In distribution | |
| 2823027 | In distribution | |
| 2802102 | In distribution | |
| 2808206 | In distribution | |
| 2802104 | In distribution | |
| 2801100 | In distribution | |
| 2835030 | In distribution | |
| 2845126 | In distribution | |
| 2830035 | In distribution | |
| 2805006 | In distribution | |
| 2814005 | In distribution | |
| 2845135 | In distribution | |
| 2833035 | In distribution | |
| 2835024 | In distribution | |
| 2802100 | In distribution | |
| 2807202 | In distribution | |
| 2830018 | In distribution | |
| 2802018 | In distribution | |
| 2830024 | In distribution | |
| 2845122 | In distribution | |
| 2845120 | In distribution | |
| 2801216 | In distribution | |
| 2813006 | In distribution | |
| 2801102 | In distribution | |
| 2807002 | In distribution | |
| 2830016 | In distribution | |
| 2832102 | In distribution | |
| 2808107 | In distribution | |
| 2832103 | In distribution | |
| 2830030 | In distribution | |
| 2822010 | In distribution | |
| 2830040 | In distribution | |
| 2807104 | In distribution | |
| 2837112 | In distribution | |
| 2815002 | In distribution | |
| 2822114 | In distribution | |
| 2832154 | In distribution | |
| 2805019 | In distribution | |
| 2807201 | In distribution | |
| 2802110 | In distribution | |
| 2837124 | In distribution | |
| 2830050 | In distribution | |
| 2801224 | In distribution | |
| 2807404 | In distribution | |
| 2837118 | In distribution | |
| 2808105 | In distribution | |
| 2822120 | In distribution | |
| 2835040 | In distribution | |
| 2808208 | In distribution | |
| 2835018 | In distribution | |
| 2822014 | In distribution | |
| 2845116 | In distribution | |
| 2801103 | In distribution | |
| 2808106 | In distribution | |
| 2835045 | In distribution | |
| 2801101 | In distribution | |
| 2812005 | In distribution | |
| 2802020 | In distribution | |
| 2822012 | In distribution | |
| 2832106 | In distribution | |
| 2835010 | In distribution | |
| 2835014 | In distribution | |
| 2802106 | In distribution |
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 |
|---|---|
| K233396 | 2023-12-21 |
| K133662 | 2014-05-15 |
| K122596 | 2012-11-20 |
| K111994 | 2011-10-11 |
| K100325 | 2010-05-04 |
| K090656 | 2009-06-03 |
| K082516 | 2008-09-17 |
| K073509 | 2008-03-04 |
| K060736 | 2006-04-18 |
| K053344 | 2006-02-23 |
| K051310 | 2005-07-26 |
| K050226 | 2005-02-11 |
| K040542 | 2004-08-19 |
| K040656 | 2004-05-25 |
| K040331 | 2004-04-14 |
| K032224 | 2003-08-08 |
| K031685 | 2003-07-01 |
| K023021 | 2002-10-04 |
| K020159 | 2002-03-26 |
| K002274 | 2001-03-07 |
| K003599 | 2001-02-15 |
| K994202 | 2000-02-25 |
| K992945 | 1999-11-18 |
| K984320 | 1999-01-28 |
| K980841 | 1998-05-20 |
| K965073 | 1997-02-27 |
| K943539 | 1994-10-19 |
Recalls
11 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 |
|---|---|---|---|---|---|
| 2025-11-24 | Class II | Packaging process control | Removal of affected lot of screws due to labeling error. | 168 units (US 83; OUS 85) | |
| 2021-09-20 | Class II | Process control | The product label incorrectly indicated that the screws are fully threaded, but the screws contained in the package were partially threaded. | 5 units | 2023-03-24 |
| 2018-03-07 | Class II | Under Investigation by firm | One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch. | 59 units | 2018-10-31 |
| 2017-03-09 | Class II | Labeling Change Control | The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. | 197 units | 2019-08-21 |
| 2017-03-09 | Class II | Labeling Change Control | The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. | 100 units | 2019-08-21 |
| 2017-03-09 | Class II | Labeling Change Control | The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling. | 19 units | 2019-08-21 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 43385 US | 2016-04-20 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 24574 US | 2016-04-20 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 1735 US | 2016-04-20 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 240 US | 2016-04-20 |
| 2013-08-06 | Class II | Packaging | Pinholes detected in a small number of primary pouches that may constitute a breach of the sterile barrier. | 725 US | 2016-04-20 |
| 2012-02-06 | Not classified | Packaging process control | Mislabeled: The device was labeled as a standard thread screw (P/N 72201772) on pouch and box, however the device contained in the packaging is a reverse thread screw (P/N 72201773). | 194 units | 2016-02-29 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 5530 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 6775 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 1274 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 2375 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 600 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 6925 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 2780 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 1461 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 278 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 2903 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 3251 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 2357 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 1990 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 3001 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 537 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 7805 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 2569 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 275 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 952 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 3791 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 3870 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 4411 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 53 units | 2012-05-09 |
| 2007-08-21 | Not classified | Nonconforming Material/Component | Patient Reaction: Post operative condition sterile fluid pocket has been identified, including the potential for graft failure and premature material degradation. | 500 units | 2012-05-09 |
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.