Integra® DigiFuse® Implant System
The Integra DigiFuse Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of…
The Integra DigiFuse Implant is a one-piece threaded device intended to be implanted into the medullary bone of the lesser toes. The implant is offered in several variations consisting of the combination of 2.0mm and 2.5mm, 0° and 10° blades, as well as standard and short blade options. A 2.0mm x 0° mini-blade is also offered for DIP fusions and smaller anatomy. The system includes instruments to facilitate the placement of the implants. All implants are made from Titanium Alloy, and instrumentation is made from titanium and stainless steel. The DigiFuse implant is indicated for the fixation of osteotomies and reconstruction of the lesser phalanges during procedures to correct deformities of the toes and fingers.
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) | K111536 |
| 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 |
|---|---|---|
| DF2000S | 16.84 mm L x 2.10 mm dia; 0 degree angle | In distribution |
| DF2000 | 20.34 mm L x 2.10 mm dia; 0 degree angle | In distribution |
| DF2010 | 20.25 mm L x 2.10 mm dia; 10 degree angle | In distribution |
| DF2000M | 11.09 mm L x 2.10 mm dia; 0 degree angle | In distribution |
| DF2500 | 24.32 mm L x 2.50 mm dia; 0 degree angle | In distribution |
| DF2510 | 24.22 mm L x 2.50 mm dia; 0 degree angle | In distribution |
| DF2010S | 16.77 mm L x 2.10 mm dia; 10 degree angle | In distribution |
| DIGIFUSEIMP2 | 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.