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
22manufacturers in China registered for this device type
119catalogue numbers in this listing
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Zhejiang (3). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Kingj Medical Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 7 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
| Beijing AK Medical Co., Ltd. | Changping District | Beijing | Contract manufacturer | 3 |
Showing 12 of 22. All 22 manufacturers in China registered for Plate, Fixation, Bone
Record
| Listed by | Crossroads Extremity Systems LLC, United States |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K160300 |
| Record published | 2018-07-02 |
| Record revised | 2026-03-09 (version 8) |
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 |
| Label carries | lot or batch number, expiry date |
| Sizes | Outer diameter 2.5 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, 3mm x 16mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3.5mm x 10mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 18mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 36mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 38mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 30mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 8mm | Length 8 mm | In distribution |
| Implant, MotoBAND CP, Y Plate, Right | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3mm x 14mm – Sterile | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3mm x 26mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 20mm | Length 20 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 30mm – Sterile | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 28mm | Length 28 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 40mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 14mm | Length 14 mm | In distribution |
| Implant, MotoBAND CP, MTP Plate, Right | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 50mm – Sterile | In distribution | |
| Implant, 3.5mm x 42mm Anti-Drift Bolt, Fully Threaded | In distribution | |
| MotoBAND CP, Locking Screw, 3.5mm x 26mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| Implant, 3.5mm x 38mm Anti-Drift Bolt, Fully Threaded | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 28mm | Length 28 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 50mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| Implant, 3.5mm x 44mm Anti-Drift Bolt | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 50mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 8mm – Sterile | Outer Diameter 3 mm | In distribution |
| DynaForce MTP Standard Plate with Slot, 5deg valgus, 5deg dorsiflexion, 18mm Cli | In distribution | |
| Implant, 3.5mm x 36mm Anti-Drift Bolt, Fully Threaded | In distribution | |
| Implant, MotoBAND CP, 4-Hole Straight Plate | In distribution | |
| Implant, 3.5mm x 28mm Anti-Drift Bolt | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 32mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 30mm | Length 30 mm | In distribution |
| Implant, 3.5mm x 42mm Anti-Drift Bolt | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 38mm – Sterile | Length 38 mm | In distribution |
| Implant, MotoBAND CP, Double Y Plate, Left | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 30mm | Length 30 mm | In distribution |
| Implant, MotoBAND CP, 2-Hole Straight Plate – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 20mm – Sterile | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 44mm – Sterile | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 16mm | Length 16 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 45mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 14mm – Sterile | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 24mm | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 18mm – Sterile | In distribution | |
| DynaForce MTP Standard Plate with Slot, 5deg valgus, 5deg dorsiflexion, 20mm Cli | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 36mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 34mm – Sterile | Length 34 mm | In distribution |
| DynaForce MTP Standard Plate with Slot, 5deg valgus, 0deg dorsiflexion, 20mm Cli | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 16mm – Sterile | Outer Diameter 3 mm | In distribution |
| Implant, 3.5mm x 32mm Anti-Drift Bolt | In distribution | |
| DynaForce MTP Standard Plate with Slot, 5deg valgus, 0deg dorsiflexion, 18mm Cli | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 32mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 36mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 28mm – Sterile | Outer Diameter 3 mm | In distribution |
| Implant, 3.5mm x 30mm Anti-Drift Bolt | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 42mm – Sterile | Length 42 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 16mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 46mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| Implant, 3.5mm x 46mm Anti-Drift Bolt, Fully Threaded | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 28mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 22mm | Length 22 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 45mm – Sterile | Length 45 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 12mm – Sterile | In distribution | |
| DynaForce MTP Standard Plate with Slot, 5deg valgus, 0deg dorsiflexion, 20mm Cli | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 10mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 22mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 12mm | Length 12 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 8mm | Length 8 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 12mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3.5mm x 30mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Locking Screw, 3.5mm x 14mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 20mm – Sterile | Outer Diameter 3 mm | In distribution |
| DynaForce MTP Standard Plate with Slot, 5deg valgus, 5deg dorsiflexion, 18mm Cli | In distribution | |
| DynaForce MTP Standard Plate with Slot, 5deg valgus, 5deg dorsiflexion, 20mm Cli | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 12mm | Length 12 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 46mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 24mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 40mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 26mm | Length 26 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 34mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 44mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| Implant, 3.5mm x 28mm Anti-Drift Bolt, Fully Threaded | Outer Diameter 3.5 mm | In distribution |
| Implant, 3.5mm x 44mm Anti-Drift Bolt, Fully Threaded | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Locking Screw, 3.5mm x 8mm – Sterile | Length 8 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 40mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 32mm – Sterile | Outer Diameter 3 mm | In distribution |
| Implant, MotoBAND CP, Y Plate, Right – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3.5mm x 18mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 26mm – Sterile | In distribution | |
| DynaForce MTP Standard Plate with Slot, 5deg valgus, 0deg dorsiflexion, 18mm Cli | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 50mm – Sterile | Outer Diameter 3 mm | In distribution |
| Implant, 3.5mm x 34mm Anti-Drift Bolt, Fully Threaded | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 28mm – Sterile | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 10mm | Length 10 mm | In distribution |
| Implant, 3.5mm x 32mm Anti-Drift Bolt, Fully Threaded | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 24mm – Sterile | In distribution | |
| Implant, 3.5mm x 34mm Anti-Drift Bolt | In distribution | |
| Implant, 3.5mm x 36mm Anti-Drift Bolt | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 20mm | Length 20 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 12mm – Sterile | Outer Diameter 3 mm | In distribution |
| Implant, 3.5mm x 30mm Anti-Drift Bolt, Fully Threaded | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 46mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 40mm – Sterile | Outer Diameter 3 mm | In distribution |
| Implant, MotoBAND CP, Double Y Plate, Right | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 14mm | Length 14 mm | In distribution |
| Implant, 3.5mm x 40mm Anti-Drift Bolt, Fully Threaded | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3mm x 10mm – Sterile | In distribution | |
| MotoBAND CP, Locking Screw, 3mm x 22mm – Sterile | Length 22 mm | In distribution |
| MotoBAND CP, Polyaxial Locking Screw, 3.5mm x 8mm – Sterile | Outer Diameter 3.5 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3.5mm x 20mm – Sterile | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3mm x 22mm – Sterile | In distribution | |
| MotoBAND CP, Polyaxial Locking Screw, 3mm x 48mm – Sterile | Length 48 mm | In distribution |
| Implant, 3.5mm x 40mm Anti-Drift Bolt | In distribution | |
| MotoBAND CP, Non-Locking Screw, 3mm x 36mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Locking Screw, 3mm x 44mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Non-Locking Screw, 3mm x 32mm – Sterile | Outer Diameter 3 mm | In distribution |
| MotoBAND CP, Locking Screw, 3.5mm x 24mm – Sterile | Length 24 mm | In distribution |
| Implant, 3.5mm x 38mm Anti-Drift Bolt | In distribution | |
| MotoBAND CP Plate Fixation Pin – Sterile | Withdrawn | |
| MotoBAND CP 2.5mm Reamer – Sterile | Outer Diameter 2.5 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pectus System | Biomet Microfixation | 4,662 |
| Arthrex® | Arthrex, Inc. | 3,031 |
| Evos | Smith & Nephew, Inc. | 2,235 |
| Peri-Loc | Smith & Nephew, Inc. | 2,196 |
| OsteoMed | Osteomed | 1,961 |
| VariAx | Stryker GmbH | 1,934 |
| Aptus | Medartis Inc. | 1,688 |
| TC-100 | Smith & Nephew, Inc. | 1,639 |
| Plate, Fixation, Bone | Synthes Gmbh | 1,613 |
| Anthem | Globus Medical, Inc. | 1,551 |
| Acumed | Acumed LLC | 1,360 |
| Signex | Osteonic Co., Ltd. | 1,310 |
Showing 12 of 3,530. All products under Plate, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253178 | 2026-01-06 |
| K230591 | 2023-09-29 |
| K223342 | 2023-03-30 |
| K190658 | 2019-04-12 |
| K181872 | 2019-02-19 |
| K160300 | 2016-04-22 |
| K152306 | 2015-12-11 |
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.