Piccolo Composite Plate System
Tibial Medial plate intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated…
Tibial Medial plate intended to buttress metaphyseal fractures of the medial tibia plateau, split-type fractures of the medial tibia plateau, medial split fractures with associated depressions and split or depression fractures of the medial tibia plateau. The plates may also be used for fixation of the proximal quarter (lateral and medial) of the tibia as well as segmental fractures of the proximal tibia.
22manufacturers in China registered for this device type
183catalogue 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 | CarboFix Orthopedics, Ltd., Israel |
|---|---|
| FDA product code | HRS |
| Device type | Plate, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3030 |
| Establishment | Manufacturer |
| 510(k) | K120409 |
| Record published | 2016-09-18 |
| Record revised | 2025-02-06 (version 7) |
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 | Length 10 to 350 mm; outer diameter 1.25 to 10 mm; lumen/inner diameter 1.4 to 8 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Depth Gauge | In distribution | |
| Sleeve | Lumen/Inner Diameter 8 mm | In distribution |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Lapidus Plate | Length 36 mm | In distribution |
| Non-Locking Screw | Outer Diameter 2.7 mm | In distribution |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| MTP Plate – Narrow | D-Angle: 5 Degrees | In distribution |
| K-Wire | Length 150 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Template – 4H Right | In distribution | |
| Locking Screw | Length 37.5 mm | In distribution |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Template – Standard 7H Left | In distribution | |
| Non-Locking Screw | Outer Diameter 2.7 mm | In distribution |
| Proximal Tibia Template, Lateral, Left | In distribution | |
| Distal Femur Plate | Number of Shaft Holes: 16 | In distribution |
| Cannulated Screw | Length 20 mm | In distribution |
| Tibial Lateral Plate, 4 holes, Right | Length 87 mm | In distribution |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 2.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 2.7 mm | In distribution |
| Smooth Peg | Outer Diameter 2 mm | In distribution |
| Distal Volar Radius Plate – Triangular | Right/Left: R | In distribution |
| Unicortical Screw | Outer Diameter 5 mm | In distribution |
| Torque Limiter | In distribution | |
| Non-Locking Screw | Outer Diameter 2.7 mm | In distribution |
| Drill Bit | Outer Diameter 2.5 mm | In distribution |
| Sterilization Case | In distribution | |
| Cannulated Screw | Length 28 mm | In distribution |
| Unicortical Screw | Outer Diameter 5 mm | In distribution |
| Proximal Tibia Template, Medial, Left | In distribution | |
| Distal Femur Plate | Number of Shaft Holes: 8 | In distribution |
| Template – 6H Left | In distribution | |
| Distal Volar Radius Plate – Triangular | Right/Left: R | In distribution |
| Tibial Medial Plate, 8 holes, Right | Length 139 mm | In distribution |
| Tibial Lateral Plate, 12 holes, Right | Length 207 mm | In distribution |
| Drill Bit | Outer Diameter 4.3 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Screwdriver Rod – T7 | In distribution | |
| Hohmann Retractor – Narrow | In distribution | |
| Variable Angle Drill Guide | In distribution | |
| Locking Screw | Outer Diameter 2.7 mm | In distribution |
| Targeting Guide – Narrow Right | In distribution | |
| Locking Screw | Outer Diameter 2.5 mm | In distribution |
| MTP Plate | D-Angle: 5 Degrees | In distribution |
| Tibial Lateral Plate, 6 holes, Right | Length 117 mm | In distribution |
| Drill Bit | Outer Diameter 4.5 mm | In distribution |
| Cannulated Screw | Length 36 mm | In distribution |
| Depth Gauge | In distribution | |
| Smooth Peg | Outer Diameter 2 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Template – Standard 3H 4H Right | In distribution | |
| MTP Plate – Narrow | D-Angle: 0 Degrees | In distribution |
| Locking Screw | Outer Diameter 5 mm | In distribution |
| Locking Screw | Length 30 mm | In distribution |
| Cannulated Screw | Outer Diameter 3.5 mm | In distribution |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Locking Screw | Outer Diameter 5 mm | In distribution |
| Sterilization Case | In distribution | |
| Tibial Lateral Plate, 6 holes, Left | Length 117 mm | In distribution |
| Lapidus Plate | Plantar Step: 2 mm | In distribution |
| Targeting Guide – Standard Left | In distribution | |
| Locking Screw | Outer Diameter 2.7 mm | In distribution |
| Drill Bit | Outer Diameter 2.8 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Distal Femur Plate | Number of Shaft Holes: 12 | In distribution |
| Non-Locking Screw | Outer Diameter 2.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Screwdriver – H2.5 – Cannulated | In distribution | |
| Locking Screw | Length 50 mm | In distribution |
| K-Wire | Length 150 mm | In distribution |
| Tibial Medial Plate, 6 holes, Left | Length 112 mm | In distribution |
| Non-Locking Screw | Length 65 mm | In distribution |
| K-Wire | Outer Diameter 1.6 mm | In distribution |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Tibial Lateral Plate, 12 holes, Left | Length 207 mm | In distribution |
| Drill Bit – Cannulated | Outer Diameter 2.7 mm | In distribution |
| Tibial Lateral Plate, 10 holes, Left | Length 177 mm | In distribution |
| Template – 2.0 mm | In distribution | |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Template – Left 500505 | In distribution | |
| Template – 9H Right | In distribution | |
| Smooth Peg | Outer Diameter 2 mm | In distribution |
| Template – Right 500505 | In distribution | |
| Screwdriver Handle – Medium | In distribution | |
| Opening Pin | In distribution | |
| Tibial Medial Plate,4 holes, Right | Length 85 mm | In distribution |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 2.5 mm | In distribution |
| Template – 11H Left | In distribution | |
| Handle Screw | In distribution | |
| Free Hand Drill Sleeve | Inner Diameter: 2.0 / 2.8 Millimeter | In distribution |
| Proximal Tibia Template, Medial, Right | In distribution | |
| Template – Triangular Right | In distribution | |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Diaphyseal Plate – Broad | Length 185 mm | In distribution |
| Tibial Lateral Plate, 10 holes, Right | Length 177 mm | In distribution |
| Non-Locking Screw | Outer Diameter 2.5 mm | In distribution |
| Template – 1.0 mm | In distribution | |
| Tibial Medial Plate, 12 holes, Right | Length 193 mm | In distribution |
| Targeting Guide – Triangular Left | In distribution | |
| Forceps – Lobster Claw | In distribution | |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Distal Femur Plate | Number of Shaft Holes: 12 | In distribution |
| Distal Femur Plate | Number of Shaft Holes: 16 | In distribution |
| Cannulated Screw | Length 32 mm | In distribution |
| Cannulated Screw | Outer Diameter 3.5 mm | In distribution |
| Unicortical Screw | Outer Diameter 5 mm | In distribution |
| Locking Screw | Length 40 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Tibial Medial Plate, 8 holes, Left | Length 139 mm | In distribution |
| Template – Flat | In distribution | |
| Locking Screw | Outer Diameter 2.7 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Lapidus Plate | Plantar Step: 0 | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Length 65 mm | In distribution |
| Locking Screw | Outer Diameter 2.7 mm | In distribution |
| Locking Screw | Outer Diameter 2.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Screwdriver Handle | In distribution | |
| Tibial Medial Plate, 10 holes, Right | Length 166 mm | In distribution |
| Locking Screw | Length 35 mm | In distribution |
| Targeting Guide Drill Sleeve | Lumen/Inner Diameter 2.0 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Tibial Lateral Plate, 8 holes, Right | Length 147 mm | In distribution |
| Template – Narrow Right | In distribution | |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Aiming Arm Screwdriver | In distribution | |
| Cannulated Screw | Outer Diameter 3.5 mm | In distribution |
| Handle – Left | In distribution | |
| Tibial Medial Plate, 12 holes, Left | Length 193 mm | In distribution |
| Proximal Tibia Template, Lateral, Right | In distribution | |
| Non-Locking Screw | Outer Diameter 2.7 mm | In distribution |
| Non- Locking Screw | Length 37.5 mm | In distribution |
| Free Hand Drill Sleeve | Lumen/Inner Diameter 2.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Tibial Lateral Plate, 4 holes, Left | Length 87 mm | In distribution |
| Cannulated Screw | Outer Diameter 3.5 mm | In distribution |
| Locking Screw | Length 60 mm | In distribution |
| Distal Volar Radius Plate – Triangular | Right/Left: L | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Drill Bit | Outer Diameter 3.0 mm | In distribution |
| Tibial Medial Plate, 6 holes, Right | Length 112 mm | In distribution |
| MTP Plate | V-Angle: 5 Degrees | In distribution |
| Cannulated Screw | Outer Diameter 3.5 mm | In distribution |
| Screwdriver Rod T25 Long | In distribution | |
| K-Wire Sleeve | Lumen/Inner Diameter 2.0 mm | In distribution |
| Locking Screw | Length 20 mm | In distribution |
| Locking Screw | Outer Diameter 2.7 mm | In distribution |
| Distal Femur Plate | Number of Shaft Holes: 8 | In distribution |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Forceps – Pointed Tip | In distribution | |
| Locking Screw | Outer Diameter 2.5 mm | In distribution |
| Smooth Peg | Outer Diameter 2 mm | In distribution |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Tibial Lateral Plate, 8 holes, Left | Length 147 mm | In distribution |
| K-Wire Ruler | In distribution | |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Tibial Medial Plate,4 holes,Left | Length 85 mm | In distribution |
| Screwdriver Rod – T10 | In distribution | |
| Screw Holder | In distribution | |
| MTP Plate – Narrow | V-Angle: 5 Degrees | In distribution |
| Locking Screw | Length 45 mm | In distribution |
| Locking Screw | Outer Diameter 5 mm | In distribution |
| Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Periosteal Elevator | In distribution | |
| Non-Locking Screw | Outer Diameter 3.5 mm | In distribution |
| Tibial Medial Plate, 10 holes, Left | Length 166 mm | In distribution |
| MTP Plate – Narrow | V-Angle: 5 Degrees | In distribution |
| Cannulated Screw | Length 24 mm | In distribution |
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 |
|---|---|
| K201917 | 2020-10-08 |
| K182015 | 2018-10-11 |
| K170401 | 2017-05-12 |
| K160002 | 2016-03-09 |
| K143496 | 2015-05-29 |
| K130061 | 2013-02-27 |
| K120409 | 2012-11-26 |
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.