Integra® Total Foot System
The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization…
The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. The instrumentation is manufactured from biocompatible materials. The 2-Hole Straight Tarsalis Plate is offered in short and long lengths. The 3-Hole and 10-Hole Straight Plates are included in the system as standard lengths. The 4-Hole Straight Tarsalis Plate is offered in both standard and short lengths. The Crescentic Tarsalis Plate is offered in left and right configurations. The 4-Hole Diamond Plate is available in left and right configurations. The T-Shaped Tarsalis Plates are offered in 4-hole, 5-hole, and 6-hole configurations. The 5-hole designs are provided in straight, left, and right configurations. The 6-hole is only provided in straight configuration. Upon request, the 6-hole, 7-hole and 8-hole T-Shaped Tarsalis Plates are available.
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) | K100502 |
| 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 |
|---|---|---|
| 2802104 | 26.0 mm L x 16.0 mm W; 4 mm stem | In distribution |
| 2845132 | 32 mm L x 3.5 mm dia | In distribution |
| 2801214 | 14 mm | In distribution |
| 2837114 | 14 mm L x 2.7 mm dia | In distribution |
| 2802016 | 16 mm | In distribution |
| 2835035 | 35 mm L x 2.7 mm dia | In distribution |
| 2808107 | 45.82 mm L x 14.79 mm W | In distribution |
| 2830016 | 16 mm L x 3.5 mm dia | In distribution |
| 2830022 | 22 mm L x 3.5 mm dia | In distribution |
| 2802018 | 18 mm | In distribution |
| 2808305 | 39.35 mm L x 14.83 mm W | In distribution |
| 2822106 | 6 mm L x 2.2 mm dia | In distribution |
| 2812005 | 100.0 mm L | In distribution |
| 2801101 | 37 mm L x 1.6 mm W x 1.00 mm H | In distribution |
| 2832152 | 26.52 mm L x 15.0 mm W x 4.5 mm H; 2.5 mm stem | In distribution |
| 2808306 | 48.0 mm L x 14.79 mm W | In distribution |
| 2801230 | 30 mm | In distribution |
| 2822006 | 6 mm L x 2.2 mm dia | In distribution |
| 2802030 | 30 mm | In distribution |
| 2802106 | 28.0 mm L x 16.0 mm W; 6 mm stem | In distribution |
| 2801103 | 37 mm L x 1.6 mm W x 3.00 mm H | In distribution |
| 2845140 | 40 mm L x 3.5 mm dia | In distribution |
| 2837118 | 18 mm L x 2.7 mm dia | In distribution |
| 2822020 | 20 mm L x 2.2 mm dia | In distribution |
| 2822110 | 10 mm L x 2.2 mm dia | In distribution |
| 2837130 | 30 mm L x 2.7 mm dia | In distribution |
| 2837110 | 10 mm L x 2.7 mm dia | In distribution |
| 2830020 | 20 mm L x 3.5 mm dia | In distribution |
| 2822008 | 8 mm L x 2.2 mm dia | In distribution |
| 2813006 | 78.0 mm L | In distribution |
| 2807104 | 29.5 mm L x 15.0 mm W | In distribution |
| 2845150 | 50 mm L x 3.5 mm dia | In distribution |
| 2835024 | 24 mm L x 2.7 mm dia | In distribution |
| 2802102 | 24.0 mm L x 16.0 mm W; 2 mm stem | In distribution |
| 2808206 | 48.0 mm L x 14.79 mm W | In distribution |
| 2830014 | 14 mm L x 3.5 mm dia | In distribution |
| 2845128 | 28 mm L x 3.5 mm dia | In distribution |
| 2808208 | 50.26 mm L x 14.10 mm W | In distribution |
| 2835018 | 18 mm L x 2.7 mm dia | In distribution |
| 2807201 | 29.0 mm L x 15.5 mm W | In distribution |
| 2808205 | 39.35 mm L x 14.83 mm W | In distribution |
| 2808108 | 50.26 mm L x 14.10 mm W | In distribution |
| 2812003 | 76.0 mm L | In distribution |
| 2803009 | 54 mm | In distribution |
| 2808106 | 46.85 mm L x 14.8 mm W | In distribution |
| 2822114 | 14 mm L x 2.2 mm dia | In distribution |
| 2815002 | Size Medium | In distribution |
| 2830045 | 45 mm L x 3.5 mm dia | In distribution |
| 2830032 | 32 mm L x 3.5 mm dia | In distribution |
| 2802020 | 20 mm | In distribution |
| 2802024 | 24 mm | In distribution |
| 2806208 | 8 mm step | In distribution |
| 2822012 | 12 mm L x 2.2 mm dia | In distribution |
| 2823027 | 2.10 mm H; 6.0 mm outer dia x 3.57 inner dia | In distribution |
| 2815004 | Size Extra Small | In distribution |
| 2822120 | 20 mm L x 2.2 mm dia | In distribution |
| 2830040 | 40 mm L x 3.5 mm dia | In distribution |
| 2845118 | 18 mm L x 3.5 mm dia | In distribution |
| 2845114 | 14 mm L x 3.5 mm dia | In distribution |
| 2835028 | 28 mm L x 2.7 mm dia | In distribution |
| 2808105 | 38.5 mm L x 15.0 mm W | In distribution |
| 2822014 | 14 mm L x 2.2 mm dia | In distribution |
| 2813008 | 102.0 mm L | In distribution |
| 2804014 | 66 mm | In distribution |
| 2822118 | 18 mm L x 2.2 mm dia | In distribution |
| 2808004 | 44 mm L x 2 mm W | In distribution |
| 2837122 | 22 mm L x 2.7 mm dia | In distribution |
| 2832153 | 26.52 mm L x 15.0 mm W x 4.5 mm H; 3.5 mm stem | In distribution |
| 2830028 | 28 mm L x 3.5 mm dia | In distribution |
| 2835022 | 22 mm L x 2.7 mm dia | In distribution |
| 2822108 | 8 mm L x 2.2 mm dia | In distribution |
| 2837150 | 50 mm L x 2.7 mm dia | In distribution |
| 2808207 | 45.82 mm L x 14.79 mm W | In distribution |
| 2807404 | 33.0 mm L x 24.0 mm W | In distribution |
| 2837145 | 45 mm L x 2.7 mm dia | In distribution |
| 2802108 | 30.0 mm L x 16.0 mm W; 8 mm stem | In distribution |
| 2815001 | Size Small | In distribution |
| 2835026 | 26 mm L x 2.7 mm dia | In distribution |
| 2830024 | 24 mm L x 3.5 mm dia | In distribution |
| 2801100 | 37 mm L x 1.6 mm W x 0.00 mm H | In distribution |
| 2835045 | 45 mm L x 2.7 mm dia | In distribution |
| 2801106 | 37 mm L x 1.6 mm W x 6.00 mm H | In distribution |
| 2837135 | 35 mm L x 2.7 mm dia | In distribution |
| 2801224 | 24 mm | In distribution |
| 2833035 | 1.8 mm H; 7.0 mm outer dia x 3.7 mm inner dia | In distribution |
| 2837124 | 24 mm L x 2.7 mm dia | In distribution |
| 2837112 | 12 mm L x 2.7 mm dia | In distribution |
| 2806210 | 10 mm step | In distribution |
| 2802014 | 14 mm | In distribution |
| 2805007 | 57.93mm L x 42.63mm W x 1.3mm H | Withdrawn |
| TARSALISIMP | Withdrawn | |
| 2832103 | 26.52 mm L x 15 mm W x 4.5 mm H; 3 mm stem | Withdrawn |
| 2805016 | 49.26 mm L x 16 mm W x 1.7 mm H | Withdrawn |
| 2832104 | 26.52 mm L x 15 mm W x 4.5 mm H; 4 mm stem | Withdrawn |
| 2805017 | 49.26 mm L x 16 mm W x 1.7 mm H | Withdrawn |
| 2807010 | 98 mm L x 5 mm W x 1.6 mm H | Withdrawn |
| TFSREARFTIMP | Withdrawn | |
| 2832100 | 26. 52 mm L x 15 mm W | Withdrawn |
| 2805019 | 54.26 mm L x 16 mm W x 1.7 mm H | Withdrawn |
| 2805006 | 46.69mm L x 16.67mm W x 1.3mm H | Withdrawn |
| TFSFOREFTIMP | Withdrawn | |
| 2805018 | 54.26 mm L x 16 mm W x 1.7 mm H | Withdrawn |
| 2832106 | 26.52 mm L x 15 mm W x 4.5 mm H; 6 mm stem | Withdrawn |
| RFOOTIMP | 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.