Piccolo Composite Plate System
A plate inindicated for buttressing multifragmentary distal femur fractures including supra-condylar, intra-articular and extraarticular condylar fractures, periprosthetic fractures,…
A plate inindicated for buttressing multifragmentary distal femur fractures including supra-condylar, intra-articular and extraarticular condylar fractures, periprosthetic fractures, fractures in normal or osteopenic bone, nonunions and malunions.
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (4), Zhejiang (3). 13 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 |
| Suzhou Ahno Medical Devices Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 17 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Hangzhou Sino-MIM Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Suzhou AND Science & Technology Development Corp. | Zhangjiagang | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 17. All 17 manufacturers in China registered for Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Record
| Listed by | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | KTT |
| Device type | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K102597 |
| Record published | 2020-01-01 |
| Record revised | 2025-02-06 (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 | Length 10 to 315 mm; outer diameter 1.4 to 8 mm; lumen/inner diameter 3 to 4.3 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Non-Locking Screw | Length 13 mm | In distribution |
| Smooth Peg | Length 20 mm | In distribution |
| Screwdriver Handle – Small | In distribution | |
| Locking Screw | Length 26 mm | In distribution |
| Locking Screw | Length 22 mm | In distribution |
| Locking Screw | Length 85 mm | In distribution |
| Locking Screw | Length 42.5 mm | In distribution |
| Screwdriver Rod – T15 | In distribution | |
| Distal Fibula Plate | Number of Shaft Holes: 6 | In distribution |
| Locking Screw | Length 12 mm | In distribution |
| Drill Bit | Length 115 mm | In distribution |
| Locking Screw | Length 57.5 mm | In distribution |
| Locking Screw | Length 32.5 mm | In distribution |
| Distal Femur Plate | Right/Left: L | In distribution |
| Free Hand Drill Sleeve | Inner Diameter: 2.5 / 3.5 Millimeter | In distribution |
| Non-Locking Screw | Length 55 mm | In distribution |
| Free Hand Drill Sleeve | In distribution | |
| Non-Locking Screw | Length 22 mm | In distribution |
| Locking Screw, Ø3.5mm x 15mm | Outer Diameter 3.5 mm | In distribution |
| Torque Limiter | In distribution | |
| Locking Screw | Length 20 mm | In distribution |
| Targeting Guide – Triangular Right | In distribution | |
| Template – 16H | In distribution | |
| Locking Screw | Length 25 mm | In distribution |
| Locking Screw | Length 22.5 mm | In distribution |
| Forceps – Bone Holding | In distribution | |
| Targeting Guide | In distribution | |
| Locking Screw, Ø3.5mm x 37.5mm | Outer Diameter 3.5 mm | In distribution |
| Locking Screw | Length 22 mm | In distribution |
| K-Wire | Outer Diameter 1.6 mm | In distribution |
| Locking Screw, Ø3.5mm x 22.5mm | Outer Diameter 3.5 mm | In distribution |
| Distal Volar Radius Plate – Triangular | Length 63 mm | In distribution |
| Locking Screw | Length 45 mm | In distribution |
| Sterilization Case | In distribution | |
| Distal Fibula Plate | Number of Shaft Holes: 4 | In distribution |
| Distal Volar Radius Plate – Narrow | Length 52 mm | In distribution |
| Locking Screw | Length 95 mm | In distribution |
| Locking Screw | Length 75 mm | In distribution |
| Drill Bit | Outer Diameter 3.2 mm | In distribution |
| Distal Fibula Plate | Length 96 mm | In distribution |
| K-Wire | Outer Diameter 1.4 mm | In distribution |
| Distal Volar Radius Plate – Triangular | Length 54 mm | In distribution |
| Variable Angle Drill Guide | In distribution | |
| Trocar | Outer Diameter 4.3 mm | In distribution |
| Distal Femur Plate | Right/Left: R | In distribution |
| Proximal Tibia Medial R/L 12 H Template | In distribution | |
| Distal Fibula Plate | Length 155 mm | In distribution |
| Distal Fibula Plate | Length 96 mm | In distribution |
| Unicortical Screw | Length 12 mm | In distribution |
| Locking Screw | Length 37.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 4.5 mm | In distribution |
| Locking Screw, Ø3.5mm x 27.5mm | Length 27.5 mm | In distribution |
| Locking Screw | Outer Diameter 4 mm | In distribution |
| Screwdriver Handle | In distribution | |
| Smooth Peg | Length 24 mm | In distribution |
| Locking Screw, Ø3.5mm x 12.5mm | Outer Diameter 3.5 mm | In distribution |
| Locking Screw | Length 26 mm | In distribution |
| Non-Locking Screw | Outer Diameter 4.5 mm | In distribution |
| Depth Gauge | In distribution | |
| Locking Screw | Outer Diameter 4 mm | In distribution |
| Non-Locking Screw | Length 14 mm | In distribution |
| Proximal Humerus Plate | Length 120 mm | In distribution |
| Locking Screw | Length 10 mm | In distribution |
| Non-Locking Screw | Length 18 mm | In distribution |
| Locking Screw, Ø3.5mm x 45mm | Outer Diameter 3.5 mm | In distribution |
| Locking Screw, Ø3.5mm x 85mm | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 4.5 mm | In distribution |
| Unicortical Screw | Length 18 mm | In distribution |
| Locking Screw, Ø3.5mm x 32.5mm | Outer Diameter 3.5 mm | In distribution |
| Locking Screw | Outer Diameter 4 mm | In distribution |
| Non-Locking Screw | Outer Diameter 4.5 mm | In distribution |
| Sterilization Case | In distribution | |
| Template | In distribution | |
| Drill Sleeve | Lumen/Inner Diameter 3.0 mm | In distribution |
| Template – Narrow Left | In distribution | |
| Non-Locking Screw | Length 26 mm | In distribution |
| Locking Screw, Ø3.5mm x 20mm | Outer Diameter 3.5 mm | In distribution |
| Drill Bit | Length 125 mm | In distribution |
| Locking Screw | Length 47.5 mm | In distribution |
| Locking Screw | Length 16 mm | In distribution |
| Screwdriver Rod – T8 | In distribution | |
| Non-Locking Screw | Length 14 mm | In distribution |
| Locking Screw, Ø3.5mm x 47.5mm | Outer Diameter 3.5 mm | In distribution |
| Locking Screw, Ø3.5mm x 35mm | Outer Diameter 3.5 mm | In distribution |
| K-Wire | Outer Diameter 1.6 mm | In distribution |
| Locking Screw, Ø3.5mm x 80mm | Outer Diameter 3.5 mm | In distribution |
| Forceps – Pointed Tip | In distribution | |
| Depth Gauge | In distribution | |
| Non-Locking Screw | Length 14 mm | In distribution |
| Locking Screw | Length 14 mm | In distribution |
| One-Third Tubular Plate | Length 67 mm | In distribution |
| Template – Triangular Left | In distribution | |
| Locking Screw | Length 27.5 mm | In distribution |
| Locking Screw, Ø3.5mm x 42.5mm | Outer Diameter 3.5 mm | In distribution |
| Distal Fibula Plate | Length 72 mm | In distribution |
| Template – 6H Right | In distribution | |
| Handle – Right | In distribution | |
| Locking Screw, Ø3.5mm x 75mm | Outer Diameter 3.5 mm | In distribution |
| Proximal Tibia Lateral R/L 12 H Template | In distribution | |
| Distal Femur Plate | Right/Left: L | In distribution |
| Non-Locking Screw | Outer Diameter 4.5 mm | In distribution |
| Distal Femur Plate | Right/Left: R | In distribution |
| Non-Locking Screw | Length 22 mm | In distribution |
| Non-Locking Screw | Outer Diameter 4.5 mm | In distribution |
| Template – 11H Right | In distribution | |
| Drill Bit | Length 300 mm | In distribution |
| Locking Screw | Length 14 mm | In distribution |
| Locking Screw | Length 18 mm | In distribution |
| Distal Volar Radius Plate – Standard | Length 60 mm | In distribution |
| Non-Locking Screw | Length 90 mm | In distribution |
| Free Hand Drill Sleeve – Double | In distribution | |
| Hohmann Retractor – Wide | In distribution | |
| Distal Volar Radius Plate – Standard | Length 52 mm | In distribution |
| Non-Locking Screw | Length 40 mm | In distribution |
| Depth Gauge | In distribution | |
| Drill Bit | Outer Diameter 3.2 mm | In distribution |
| Diaphyseal Plate – Narrow | Length 154 mm | In distribution |
| Aiming Arm – 16H | In distribution | |
| Locking Screw, Ø3.5mm x 60mm | Outer Diameter 3.5 mm | In distribution |
| K-Wire | Outer Diameter 2.0 mm | In distribution |
| Distal Volar Radius Plate – Triangular | Length 72 mm | In distribution |
| Distal Volar Radius Plate – Narrow | Length 60 mm | In distribution |
| Distal Femur Plate | Right/Left: L | In distribution |
| Non-Locking Screw | Length 16 mm | In distribution |
| Drill Bit | Length 270 mm | In distribution |
| Sterilization Case | In distribution | |
| Free Hand Drill Sleeve | In distribution | |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Length 20 mm | In distribution |
| Locking Screw | Outer Diameter 4 mm | In distribution |
| Free Hand Drill Sleeve | Inner Diameter: 2.0 / 2.8 Millimeter | In distribution |
| Locking Screw | Length 12 mm | In distribution |
| Connection Screw | In distribution | |
| Locking Screw | Length 30 mm | In distribution |
| Locking Screw, Ø3.5mm x 55mm | Outer Diameter 3.5 mm | In distribution |
| Locking Screw, Ø3.5mm x 50mm | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Length 18 mm | In distribution |
| Targeting Guide – Narrow Left | In distribution | |
| Locking Screw, Ø3.5mm x 30mm | Outer Diameter 3.5 mm | In distribution |
| Locking Screw, Ø3.5mm x 10mm | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 4.5 mm | In distribution |
| Drill Bit | Length 115 mm | In distribution |
| Non-Locking Screw | Length 26 mm | In distribution |
| Non-Locking Screw | Length 32.5 mm | In distribution |
| Locking Screw | Length 18 mm | In distribution |
| One-Third Tubular Plate | Length 98 mm | In distribution |
| Reduction Device – Long | In distribution | |
| Non-Locking Screw | Length 45 mm | In distribution |
| Non-Locking Screw | Length 35 mm | In distribution |
| Locking Screw, Ø3.5mm x 25mm | Outer Diameter 3.5 mm | In distribution |
| Locking Screw | Outer Diameter 4 mm | In distribution |
| Distal Fibula Plate | Length 155 mm | In distribution |
| Locking Screw, Ø3.5mm x 40mm | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Length 18 mm | In distribution |
| Non-Locking Screw | Length 10 mm | In distribution |
| Drill Bit | Length 215 mm | In distribution |
| Distal Femur Plate | Right/Left: R | In distribution |
| Non-Locking Screw | Outer Diameter 4.5 mm | In distribution |
| Distal Fibula Plate | Number of Shaft Holes: 4 | In distribution |
| Locking Screw | Length 16 mm | In distribution |
| Locking Screw, Ø3.5mm x 90mm | Outer Diameter 3.5 mm | In distribution |
| Proximal Humerus Plate | Length 192 mm | In distribution |
| Non-Locking Screw | Length 22.5 mm | In distribution |
| Template – 4H Left | In distribution | |
| Targeting Guide – Standard Right | In distribution | |
| Countersink | In distribution | |
| Screwdriver Rod | In distribution | |
| Drill Sleeve | Outer Diameter 8 mm | In distribution |
| Template – Standard 3H 4H Left | In distribution | |
| Distal Fibula Plate | Length 72 mm | In distribution |
| Template – Standard 7H Right | In distribution | |
| Non-Locking Screw | Outer Diameter 4.5 mm | In distribution |
| Locking Screw | Length 52.5 mm | In distribution |
| Template – 9H Left | In distribution | |
| Locking Screw, Ø3.5mm x 17.5mm | Outer Diameter 3.5 mm | In distribution |
| Smooth Peg | Length 16 mm | In distribution |
| Ratchet T-Handle | In distribution | |
| Free Hand Drill Sleeve | Inner Diameter: 2.0 / 2.5 Millimeter | In distribution |
| Locking Screw | Length 24 mm | In distribution |
| Locking Screw | Length 65 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Free Hand Drill Sleeve | In distribution | |
| Locking Screw | Outer Diameter 4 mm | In distribution |
| Non-Locking Screw | Outer Diameter 4.5 mm | In distribution |
| Non-Locking Screw | Length 27.5 mm | In distribution |
| Drill Bit | Length 215 mm | In distribution |
| Sterilization Case | In distribution | |
| Non-Locking Screw | Length 24 mm | In distribution |
| Non-Locking Screw | Outer Diameter 4.5 mm | In distribution |
| Non-Locking Screw | Length 10 mm | In distribution |
| Locking Screw | Length 35 mm | In distribution |
| Locking Screw | Length 20 mm | In distribution |
| Locking Screw, Ø3.5mm x 65mm | Outer Diameter 3.5 mm | In distribution |
| Countersink | In distribution | |
| Distal Volar Radius Plate – Standard | Length 90 mm | In distribution |
| Locking Screw, Ø3.5mm x 70mm | Outer Diameter 3.5 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Smart Correction | Wishbone Medical Inc. | 1,534 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Synthes Gmbh | 880 |
| LCP | Synthes Gmbh | 355 |
| Orthex External Fixation System | Orthopediatrics, Corp | 353 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Sterilmed, Inc. | 325 |
| CHS | Smith & Nephew, Inc. | 321 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | Stryker Sustainability Solutions | 277 |
| Hoffmann | Stryker GmbH | 239 |
| Orthex | Orthopediatrics, Corp | 231 |
| Orthex | Vilex IN Tennessee, Inc. | 221 |
| Omega | Stryker GmbH | 212 |
| eZ-Fix | Orthopediatrics, Corp | 207 |
Showing 12 of 530. All products under Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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.