MotoBAND
The MotoBAND™ CP Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of…
The MotoBAND™ CP Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws. When used for these indications, certain plates within this system may be used with the MotoCLIP Implant System
31manufacturers in China registered for this device type
78catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
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 | Crossroads Extremity Systems LLC, United States |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K160300 |
| Record published | 2016-04-26 |
| Record revised | 2024-06-28 (version 16) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 2 to 3.5 mm; length 8 to 50 mm |
| Distribution end date | 2024-06-27 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MotoBAND CP, Non-Locking Screw, 3.5mm x 18mm – Sterile | In distribution | |
| Implant, MotoBAND CP, 4-Hole Straight Plate – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 18mm – Sterile | Length 18 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 24mm | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 30mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 28mm – Sterile | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 16mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 18mm | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 44mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 26mm | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 34mm – Sterile | Length 34 mm | In distribution |
| Implant, MotoBAND CP, Y Plate, Left | In distribution | |
| Implant, MotoBAND CP, 5-Hole Straight Plate – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3.5mm x 28mm – Sterile | Length 28 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 42mm – Sterile | Length 42 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 28mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3.5mm x 12mm – Sterile | Length 12 mm | In distribution |
| MotoBAND CP, Locking Screw, 3.5mm x 20mm – Sterile | Length 20 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 40mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 18mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 16mm | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 8mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 12mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 22mm – Sterile | In distribution | |
| Implant, MotoBAND CP, MTP Plate, Right – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 30mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 38mm – Sterile | Length 38 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 48mm – Sterile | In distribution | |
| MotoBAND CP, H10 Non-Retaining Driver | In distribution | |
| Implant, MotoBAND CP, MTP Plate, Left | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 32mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 14mm – Sterile | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 26mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 45mm – Sterile | Length 45 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 14mm – Sterile | Length 14 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 46mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 30mm – Sterile | Length 30 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 45mm – Sterile | Length 45 mm | In distribution |
| Implant, MotoBAND CP, Double Y Plate, Left | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 16mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 20mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 48mm – Sterile | Length 48 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 22mm – Sterile | In distribution | |
| Implant, MotoBAND CP, 2-Hole Straight Plate | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 34mm – Sterile | Length 34 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 38mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 24mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 42mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 36mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 10mm | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 10mm – Sterile | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 18mm | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 20mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 26mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 8mm – Sterile | Length 8 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 50mm – Sterile | Outer Diameter 3 mm | In distribution |
| Implant, MotoBAND CP, 5-Hole Straight Plate | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 45mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 26mm – Sterile | Length 26 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 24mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 38mm – Sterile | Length 38 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 34mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 12mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 48mm – Sterile | Length 48 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 42mm – Sterile | Length 42 mm | In distribution |
| Implant, MotoBAND CP, Y Plate, Left – Sterile | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 22mm | Length 22 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 24mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 14mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3.5mm x 22mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 10mm – Sterile | Length 10 mm | In distribution |
| MotoBAND CP, Locking Screw, 3.5mm x 16mm – Sterile | Length 16 mm | In distribution |
| Implant, MotoBAND CP, Double Y Plate, Right – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 10mm – Sterile | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 8mm – Sterile | Length 8 mm | In distribution |
| Implant, MotoBAND CP, MTP Plate, Left – Sterile | In distribution | |
| MotoBAND CP 2.0mm Reamer – Sterile | Outer Diameter 2.0 mm | Withdrawn |
| MotoBAND CP Instrument Kit – Sterile | 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 |
|---|---|
| K173710 | 2018-02-12 |
| K152072 | 2015-09-23 |
| K151270 | 2015-09-04 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Crossroads Extremity Systems LLC | 510(k) number | 2019-09-19 | Class II | Labeling mix-ups | Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw. | 36 screws | 2021-12-02 |
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.