Juniortho Plating System
The JuniOrtho nonlocking screw is a component of a plate and screw system for internal fixation of femoral and tibial fractures, osteotomies, malunions and nonunions. The system is intended…
The JuniOrtho nonlocking screw is a component of a plate and screw system for internal fixation of femoral and tibial fractures, osteotomies, malunions and nonunions. The system is intended for pediatric patients other than newborns and small stature adults.
The screw family uses AISI 316LVM stainless steel and includes locking and nonlocking designs in different lengths. The screw works with the plate construct to stabilize the treated lower limb bone.
Listed Item
JPS SS NON-Locking Screw L18MM Double Start Thread D3.5MM Sterile
Orthopedic Applications
System indications include angular or rotational correction, shortening osteotomies, femoral neck or pertrochanteric fractures and specified metaphyseal or pathological fractures. Components are offered in sterile and nonsterile packaging configurations, depending on the supplied version.
31manufacturers in China registered for this device type
539catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (15), Shanghai (5), Zhejiang (3). 19 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| 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 |
| Zibo Dante Co., Ltd. | Zibo | Shandong | Contract manufacturer | 17 |
| Sanbor Medical Xiamen, Inc. | Xiamen | Fujian | Contract manufacturer | 16 |
| Suzhou Kangli Orthopaedics Instrument Co., Ltd. | Zhangjiagang | Jiangsu | Contract manufacturer | 11 |
Showing 12 of 31. All 31 manufacturers in China registered for Screw, Fixation, Bone
Record
| Listed by | Orthofix SRL, Italy |
|---|---|
| FDA product code | HWC |
| Device type | Screw, Fixation, Bone |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3040 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K213572 |
| Record published | 2022-03-31 |
| Record revised | 2025-10-24 (version 4) |
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, manufacturing date |
| Sizes | Length 10 to 80 mm; outer diameter 3 to 5 mm; width 34 to 155 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Width 105 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 38 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Length 18 mm | In distribution |
| 1 | Length 38 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Length 42 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 100 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 40 mm | In distribution |
| 1 | Width 72 mm | In distribution |
| 1 | Length 34 mm | In distribution |
| 1 | Width 116 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 114 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Width 61 mm | In distribution |
| 1 | Width 139 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Width 92 mm | In distribution |
| 1 | Length 24 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Width 115 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 67 mm | In distribution |
| 1 | Length 20 mm | In distribution |
| 1 | Width 104 mm | In distribution |
| 1 | Length 28 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 94 mm | In distribution |
| 1 | Length 26 mm | In distribution |
| 1 | Width 73 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 36 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Length 22 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Length 24 mm | In distribution |
| 1 | Length 24 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | Width 78 mm | In distribution |
| 1 | Length 44 mm | In distribution |
| 1 | Width 81 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Width 155 mm | In distribution |
| 1 | Width 128 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Width 71 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Length 44 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 135 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 38 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Width 75 mm | In distribution |
| 1 | Width 43 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Length 18 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Length 44 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Length 14 mm | In distribution |
| 1 | Width 42 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Length 32 mm | In distribution |
| 1 | Width 130 mm | In distribution |
| 1 | Length 65 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Length 38 mm | In distribution |
| 1 | Width 82 mm | In distribution |
| 1 | Length 18 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Width 35 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 28 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Length 22 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Width 101 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 34 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 84 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | Width 134 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Length 16 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Width 41 mm | In distribution |
| 1 | Length 26 mm | In distribution |
| 1 | Width 52 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Length 10 mm | In distribution |
| 1 | Width 54 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Length 10 mm | In distribution |
| 1 | Length 12 mm | In distribution |
| 1 | Width 131 mm | In distribution |
| 1 | Width 93 mm | In distribution |
| 1 | Length 20 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 83 mm | In distribution |
| 1 | Length 38 mm | In distribution |
| 1 | Width 112 mm | In distribution |
| 1 | Length 48 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Length 14 mm | In distribution |
| 1 | Length 30 mm | In distribution |
| 1 | Length 22 mm | In distribution |
| 1 | Width 48 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 107 mm | In distribution |
| 1 | Width 86 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Length 20 mm | In distribution |
| 1 | Length 36 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | In distribution | |
| 1 | Width 99 mm | In distribution |
| 1 | Width 133 mm | In distribution |
| 1 | Width 110 mm | In distribution |
| 1 | Length 36 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 111 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 138 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Width 118 mm | In distribution |
| 1 | Width 53 mm | In distribution |
| 1 | Length 60 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Length 38 mm | In distribution |
| 1 | Width 146 mm | In distribution |
| 1 | Length 26 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 50 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Length 40 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Width 143 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Length 26 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Width 39 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Width 77 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Length 18 mm | In distribution |
| 1 | Width 120 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Length 55 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Width 69 mm | In distribution |
| 1 | In distribution | |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 4.5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Length 28 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
| 1 | Width 149 mm | In distribution |
| 1 | Width 79 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3.5 mm | In distribution |
| 1 | Outer Diameter 3 mm | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Screw, Fixation, Bone | Synthes Gmbh | 3,975 |
| Aptus | Medartis Inc. | 3,623 |
| Acumed | Acumed LLC | 3,187 |
| Arthrex® | Arthrex, Inc. | 2,781 |
| OsteoMed | Osteomed | 2,764 |
| Screw, Fixation, Bone | AAP Implantate AG | 2,176 |
| Screw, Fixation, Bone | Zimmer, Inc. | 1,993 |
| Arix System Bone Screw | Jeil Medical Corporation | 1,875 |
| Cannulated Screw System + | Tyber Medical | 1,814 |
| Cannulated Compression Headless Screw | Tyber Medical | 1,621 |
| Microware Bone Plates and Bone Screws | Microware Precision Co., Ltd. | 1,601 |
| Anthem | Globus Medical, Inc. | 1,538 |
Showing 12 of 5,775. All products under Screw, Fixation, Bone
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213572 | 2022-01-18 |
| K172698 | 2018-02-07 |
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.