Piccolo Composite Nailing System
An ankle arthrodesis nail indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include: Avascular necrosis of the talus; Failed total ankle arthroplasty; Trauma…
An ankle arthrodesis nail indicated for tibiotalocalcaneal arthrodesis (fusion). Specific indications include: Avascular necrosis of the talus; Failed total ankle arthroplasty; Trauma (malunited tibial pilon fracture); Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease; Revision ankle arthrodesis; Neuroarthropathy; Rheumatoid arthritis; Osteoarthritis; Pseudoarthrosis; Post-traumatic arthrosis; Previously infected arthrosis; Charcot foot; Severe endstage degenerative arthritis; Severe defects after tumor resection; Pantalar arthrodesis
17manufacturers in China registered for this device type
422catalogue numbers in this listing
6510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Jiangsu (7), Shanghai (3), Zhejiang (3). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| 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 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 17. All 17 manufacturers in China registered for Rod, Fixation, Intramedullary And Accessories
Record
| Listed by | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | HSB |
| Device type | Rod, Fixation, Intramedullary And Accessories |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3020 |
| Establishment | Manufacturer |
| 510(k) | K091425 |
| Record published | 2015-10-15 |
| Record revised | 2024-08-01 (version 7) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| 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 2.4 to 17 mm; length 0 to 850 mm; lumen/inner diameter 2.7 to 10.5 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Cortical Screw | Outer Diameter 3.5 mm | In distribution |
| Proximal Femur Nail | 125 Degrees | In distribution |
| Drill Bit | Lumen/Inner Diameter 3.3 mm | In distribution |
| Femoral Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Lag Screw Guide Sleeve | Lumen/Inner Diameter 10.5 mm | In distribution |
| Proximal Humerus Nail | Length 150 mm | In distribution |
| Cortical Screw | Outer Diameter 5 mm | In distribution |
| Awl | Outer Diameter 17 mm | In distribution |
| Partially Threaded Screw | Outer Diameter 4 mm | In distribution |
| Cortical Screw | Length 65 mm | In distribution |
| Proximal Femur Nail | Proximal Diameter: 17 Millimeter | In distribution |
| Cortical Screw | Outer Diameter 3.5 mm | In distribution |
| Wrench | In distribution | |
| Cortical Screw | Length 18 mm | In distribution |
| Cortical Screw | Outer Diameter 3.5 mm | In distribution |
| Nail Adapter | In distribution | |
| Lag Screw | Outer Diameter 10 mm | In distribution |
| Drill Bit | Outer Diameter 4.2 mm | In distribution |
| Cortical Screw | Length 57.5 mm | In distribution |
| Proximal Femur Nail | Length 360 mm | In distribution |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Humeral Nail | Length 240 mm | In distribution |
| Cortical Screw | Length 47.5 mm | In distribution |
| Cancellous Screw | Length 56 mm | In distribution |
| Cortical Screw | Length 24 mm | In distribution |
| Cortical Screw | Length 65 mm | In distribution |
| Proximal Femur Nail | Length 440 mm | In distribution |
| Femoral Nail | Length 400 mm | In distribution |
| Cortical Screw | Length 22.5 mm | In distribution |
| Proximal Humerus Nail | Proximal Diameter: 11 Millimeter | In distribution |
| Cortical Screw | Outer Diameter 4 mm | In distribution |
| Proximal Femur Nail | Length 320 mm | In distribution |
| Cortical Screw | Length 26 mm | In distribution |
| Trocar | In distribution | |
| Cortical Screw | Outer Diameter 5 mm | In distribution |
| Cancellous Screw | Length 44 mm | In distribution |
| Proximal Femur Nail | Proximal Diameter: 17 Millimeter | In distribution |
| Screwdriver – Short | In distribution | |
| Nail Adapter | In distribution | |
| Femoral Nail | Proximal Diameter: 12 Millimeter | In distribution |
| Power Driver Screwdriver | In distribution | |
| Striking Adapter | In distribution | |
| Proximal Femur Nail | Proximal Diameter: 17 Millimeter | In distribution |
| Drill Bit | Outer Diameter 13.0 mm | In distribution |
| Proximal Femur Nail | Left/Right: L | In distribution |
| Cortical Screw | Outer Diameter 4 mm | In distribution |
| Proximal Femur Nail | Proximal Diameter: 17 Millimeter | In distribution |
| Opening Pin | In distribution | |
| Cortical Screw | Outer Diameter 4 mm | In distribution |
| Proximal Femur Nail | Length 320 mm | In distribution |
| Tibial Nail | Length 280 mm | In distribution |
| Humeral Nail | Proximal Diameter: 10 Millimeter | In distribution |
| Femoral Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Tissue Protector Sleeve | In distribution | |
| Proximal Femur Nail | Left/Right: R | In distribution |
| Partially Threaded Screw | Length 57.5 mm | In distribution |
| Proximal Femur Nail Cap | Length 0 mm | In distribution |
| Partially Threaded Screw | Outer Diameter 4 mm | In distribution |
| Proximal Femur Nail | Proximal Diameter: 17 Millimeter | In distribution |
| Drill Bit | Length 180 mm | In distribution |
| Drill Bit | Length 180 mm | In distribution |
| Cortical Screw | Outer Diameter 5 mm | In distribution |
| Cancellous Screw | Outer Diameter 4.5 mm | In distribution |
| Sterilization Case | In distribution | |
| Tibia Aiming Arm | In distribution | |
| Lag Screw | Outer Diameter 10.4 mm | In distribution |
| Cortical Screw | Length 100 mm | In distribution |
| Femoral Nail | Length 320 mm | In distribution |
| Proximal Femur Nail | Length 440 mm | In distribution |
| Lag Screw | Length 95 mm | In distribution |
| Proximal Femur Nail | Length 420 mm | In distribution |
| Cortical Screw | Length 52.5 mm | In distribution |
| Free Hand Drill Sleeve | In distribution | |
| Proximal Femur Nail | Length 400 mm | In distribution |
| Femoral Nail | Proximal Diameter: 12 Millimeter | In distribution |
| Cortical Screw | Outer Diameter 4.0 mm | In distribution |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Proximal Femur Nail | Left/Right: R | In distribution |
| Arthrodesis Handle Extension | In distribution | |
| Drill Bit | Lumen/Inner Diameter 3.3 mm | In distribution |
| Tibial Nail | Length 320 mm | In distribution |
| Cortical Screw | Length 20 mm | In distribution |
| Femoral Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Sterilization Case | In distribution | |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Cortical Screw | Length 57.5 mm | In distribution |
| Partially Threaded Screw | Outer Diameter 4 mm | In distribution |
| Cancellous Screw | Outer Diameter 4.5 mm | In distribution |
| Cortical Screw | Outer Diameter 5 mm | In distribution |
| Cancellous Screw | Length 52 mm | In distribution |
| Humeral Nail | Length 200 mm | In distribution |
| Nail Cap | Length 8 mm | In distribution |
| Cortical Screw | Length 52.5 mm | In distribution |
| Partially Threaded Screw | Length 75 mm | In distribution |
| Femoral Nail | Length 380 mm | In distribution |
| Tibial Nail | Length 320 mm | In distribution |
| Cortical Screw | Length 75 mm | In distribution |
| Insertion Handle | In distribution | |
| Humeral Nail | Length 280 mm | In distribution |
| Ball Tip Guide Wire | Outer Diameter 2.5 mm | In distribution |
| Screwdriver | In distribution | |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Exchange Tube | In distribution | |
| Drill Bit | Outer Diameter 3.0 mm | In distribution |
| Cancellous Screw | Length 32 mm | In distribution |
| Proximal Femur Nail Set Screw | In distribution | |
| Femoral Nail | Length 400 mm | In distribution |
| Tibial Nail | Length 360 mm | In distribution |
| Cortical Screw | Outer Diameter 5 mm | In distribution |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Femoral Nail | Length 200 mm | In distribution |
| Proximal Femur Nail | Left/Right: L | In distribution |
| Lag Screw | Outer Diameter 10.4 mm | In distribution |
| Femoral Nail | Length 200 mm | In distribution |
| Lag Screw | Outer Diameter 10 mm | In distribution |
| Humeral Nail | Length 200 mm | In distribution |
| Entry Trocar | In distribution | |
| Drill Bit | Outer Diameter 2.7 mm | In distribution |
| Arthrodesis Handle | In distribution | |
| Cortical Screw | Outer Diameter 5 mm | In distribution |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Cortical Screw | Outer Diameter 3.5 mm | In distribution |
| Arthrodesis Connection Tube Nut | In distribution | |
| Proximal Femur Nail | Proximal Diameter: 17 Millimeter | In distribution |
| Cortical Screw | Length 105 mm | In distribution |
| Humeral Nail | Length 240 mm | In distribution |
| Cortical Screw | Length 30 mm | In distribution |
| Humeral Nail | Length 280 mm | In distribution |
| Screwdriver – Long | In distribution | |
| Cancellous Screw | Outer Diameter 4.5 mm | In distribution |
| Drill Bit | Length 300 mm | In distribution |
| Cortical Screw | Length 32.5 mm | In distribution |
| Proximal Femur Nail Cap | Length 5 mm | In distribution |
| External Compression Plate 48.0 | In distribution | |
| Tibial Nail | Length 240 mm | In distribution |
| Strerilization Case | In distribution | |
| Femoral Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Proximal Femur Nail | Length 300 mm | In distribution |
| Femoral Nail | Length 380 mm | In distribution |
| Cortical Screw | Outer Diameter 4 mm | In distribution |
| Cortical Screw | Outer Diameter 4.0 mm | In distribution |
| Drill Bit | Length 300 mm | In distribution |
| Screwdriver – H2.5 | In distribution | |
| Femoral Nail | Proximal Diameter: 12 Millimeter | In distribution |
| Lag Screw | Length 100 mm | In distribution |
| Humeral Nail | Proximal Diameter: 10 Millimeter | In distribution |
| K-Wire | Length 570 mm | In distribution |
| Proximal Femur Nail | Length 440 mm | In distribution |
| Cancellous Screw | Length 28 mm | In distribution |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Removal Adapter | In distribution | |
| Femoral Nail | Length 160 mm | In distribution |
| Proximal Femur Nail Set Screw | In distribution | |
| Drill Bit | Outer Diameter 4.2 mm | In distribution |
| Drill Sleeve | Lumen/Inner Diameter 2.7 mm | In distribution |
| Cortical Screw | Outer Diameter 5 mm | In distribution |
| K-Wire Depth Gauge | In distribution | |
| Drill Bit | Lumen/Inner Diameter 3.3 mm | In distribution |
| Proximal Femur Nail | Length 380 mm | In distribution |
| Cortical Screw | Outer Diameter 4 mm | In distribution |
| Slide Hammer | In distribution | |
| Ruler | In distribution | |
| Partially Threaded Screw | Length 47.5 mm | In distribution |
| Femoral Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Partially Threaded Screw | Length 65 mm | In distribution |
| Proximal Femur Nail | Length 460 mm | In distribution |
| Screw Depth Gauge | In distribution | |
| Proximal Femur Nail | Proximal Diameter: 17 Millimeter | In distribution |
| Cortical Screw | Outer Diameter 3.5 mm | In distribution |
| Tibial Nail | Length 420 mm | In distribution |
| Femoral Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Screwdriver | In distribution | |
| Humerus Handle | In distribution | |
| Proximal Femur Nail | Length 420 mm | In distribution |
| Awl | In distribution | |
| Cortical Screw | Length 40 mm | In distribution |
| Proximal Femur Nail Cap | Length 10 mm | In distribution |
| Cancellous Screw | Outer Diameter 4.5 mm | In distribution |
| Guide Sleeve | Lumen/Inner Diameter 8.0 mm | In distribution |
| Stopper Screw With Pin | In distribution | |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Nail Adapter | In distribution | |
| Lag Screw | Outer Diameter 10.4 mm | In distribution |
| Cancellous Screw | Outer Diameter 4.5 mm | In distribution |
| Proximal Femur Nail | Left/Right: L | In distribution |
| Tibial Nail | Length 380 mm | In distribution |
| Partially Threaded Screw | Length 37.5 mm | In distribution |
| Proximal Femur Nail | Left/Right: L | In distribution |
| Trocar | In distribution | |
| Femoral Nail | Length 360 mm | In distribution |
| Drill Sleeve | Outer Diameter 8.0 mm | In distribution |
| Femoral Nail | Length 380 mm | In distribution |
| Drill Bit | Length 215 mm | In distribution |
| Awl | In distribution | |
| Proximal Femur Nail | Left/Right: R | In distribution |
| Cortical Screw | Outer Diameter 5 mm | In distribution |
| Drill Sleeve | Outer Diameter 8.0 mm | In distribution |
| Depth Gauge | In distribution | |
| Humeral Nail | Length 260 mm | In distribution |
| Femoral Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Suprapatellar Handle | In distribution | |
| Cortical Screw | Length 75 mm | In distribution |
| Proximal Femur Nail | Left/Right: L | In distribution |
| Sterilization Case | In distribution | |
| Cortical Screw | Outer Diameter 5 mm | In distribution |
| Connection Tube | In distribution | |
| Drill Sleeve | Outer Diameter 8.0 mm | In distribution |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Lag Screw | Length 100 mm | In distribution |
| Drill Bit | Outer Diameter 4.0 mm | In distribution |
| Guide Sleeve | Lumen/Inner Diameter 8.0 mm | In distribution |
| Cancellous Screw | Outer Diameter 4.5 mm | In distribution |
| Cortical Screw | Outer Diameter 4 mm | In distribution |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Proximal Femur Nail | Proximal Diameter: 17 Millimeter | In distribution |
| Proximal Femur Nail | Left/Right: L | In distribution |
| Proximal Femur Nail | Left/Right: L | In distribution |
| Proximal Aiming Arm | In distribution | |
| Femoral Nail | Proximal Diameter: 12 Millimeter | In distribution |
| Proximal Femur Nail | Left/Right: R | In distribution |
| Cancellous Screw | Length 36 mm | In distribution |
| Guide Wire | Length 850 mm | In distribution |
| Femoral Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Tibial Nail | Length 380 mm | In distribution |
| Partially Threaded Screw | Length 32.5 mm | In distribution |
| Cortical Screw | Outer Diameter 5 mm | In distribution |
| Femoral Nail | Length 340 mm | In distribution |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Proximal Femur Nail | Length 400 mm | In distribution |
| Tibial Nail | Length 360 mm | In distribution |
| Ankle Arthrodesis Nail | Proximal Diameter: 12 Millimeter | In distribution |
| Radiographic Ruler | In distribution | |
| Cancellous Screw | Outer Diameter 4.5 mm | In distribution |
| Inner Rod | In distribution | |
| Cancellous Screw | Outer Diameter 4.5 mm | In distribution |
| Partially Threaded Screw | Outer Diameter 4 mm | In distribution |
| Ankle Arthrodesis Nail | Outer Diameter 10 mm | In distribution |
| Cancellous Screw | Length 48 mm | In distribution |
| Femoral Nail | Length 400 mm | In distribution |
| Cortical Screw | Length 115 mm | In distribution |
| Cortical Screw | Outer Diameter 4 mm | In distribution |
| Cortical Screw | Length 25 mm | In distribution |
| Femoral Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
| Arthrodesis Connection Tube | In distribution | |
| Femoral Nail | Length 360 mm | In distribution |
| Drill Bit | Length 250 mm | In distribution |
| Proximal Femur Nail | Left/Right: L | In distribution |
| Tibial Nail | Proximal Diameter: 11.5 Millimeter | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| T2 | Stryker GmbH | 1,373 |
| Autobahn | Globus Medical, Inc. | 1,258 |
| Gamma | Stryker GmbH | 1,120 |
| Summa Orthopaedics Femur Nail System | Jeil Medical Corporation | 742 |
| Arix Femur Nail System | Jeil Medical Corporation | 742 |
| Orthofix | Orthofix SRL | 721 |
| Rod, Fixation, Intramedullary And Accessories | Synthes Gmbh | 715 |
| Trigen | Smith & Nephew, Inc. | 681 |
| Arthrex® | Arthrex, Inc. | 665 |
| Precice® Intramedullary Limb Lengthening System | NuVasive Specialized Orthopedics, Inc. | 596 |
| Apex | Orthoxel Designated Activity Company | 569 |
| Natural Nail® | Zimmer, Inc. | 552 |
Showing 12 of 2,207. All products under Rod, Fixation, Intramedullary And Accessories
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173652 | 2017-12-28 |
| K153536 | 2016-01-06 |
| K151010 | 2015-07-28 |
| K132774 | 2013-10-03 |
| K123810 | 2013-06-14 |
| K111056 | 2011-05-03 |
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 |
|---|---|---|---|---|---|---|---|
| CarboFix Orthopedics, Ltd. | 510(k) number | 2016-05-10 | Class II | Other | Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility. | 638 | 2017-01-27 |
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.