Piccolo Composite Plate System

A plate inindicated for buttressing multifragmentary distal femur fractures including supra-condylar, intra-articular and extraarticular condylar fractures, periprosthetic fractures,…

Registry build 21.09.26

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.

17manufacturers in China registered for this device type
196catalogue numbers in this listing

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.

Chinese manufacturers registered for FDA product code KTT
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

Regulatory record for Piccolo Composite Plate System
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

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 numbers for Piccolo Composite Plate System
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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer