JPS JuniOrtho Plating System
by Orthofix SRL
510(k) K200246
JPS JuniOrtho Plating System is a medical device (FDA Class II; FDA product code HRS, Plate, Fixation, Bone) made by Orthofix SRL, cleared under FDA 510(k) K200246 on 22 May 2020, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK200246 | Date22 May 2020 | StatusActive |
Official records
- FDA 510(k) database K200246
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRS
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3030
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K200246
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| JUNIORTHO PLATING SYSTEM 1 | 154903C / 1 | 18053340348614 | On the market | |
| JUNIORTHO PLATING SYSTEM 1 | 154993C / 1 | 18052469471050 | On the market | |
| JUNIORTHO PLATING SYSTEM 1 | 154995C / 1 | 18053340347532 | On the market | |
| JUNIORTHO PLATING SYSTEM 1 | 5403022 / 1 | 18053800899274 | Width 40 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5403034 / 1 | 18053800899335 | Width 46 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5403040 / 1 | 18053800899366 | Width 49 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5403526 / 1 | 18053800899458 | Width 58 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5403532 / 1 | 18053800899489 | Width 61 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5404546 / 1 | 18053800899694 | Width 82 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5413010 / 1 | 18053800899724 | Width 85 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5413044 / 1 | 18053800899892 | Width 102 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5413060 / 1 | 18053800899946 | Width 107 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5413518 / 1 | 18053800899991 | Width 112 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5413536 / 1 | 18053340340083 | Width 121 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5415022 / 1 | 18053340340229 | Width 135 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5415060 / 1 | 18053340340380 | Width 151 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5431007 / 1 | 18053800898055 | Width 162 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5431015 / 1 | 18053800898130 | Width 170 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5431016 / 1 | 18053800898147 | Width 171 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5431021 / 1 | 18053800898635 | Width 176 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5431025 / 1 | 18053800898741 | Width 180 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5433011 / 1 | 18053800898970 | Width 203 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5433012 / 1 | 18053800898987 | Width 204 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5434002L / 1 | 18053800899007 | Width 207 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 5434005L / 1 | 18053800899076 | Width 213 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5403016 / 1 | 18053800896808 | Length 16 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5403020 / 1 | 18053800896822 | Length 20 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5403028 / 1 | 18053800896860 | Length 28 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5403514 / 1 | 18053800896952 | Length 14 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5403526 / 1 | 18053800897010 | Length 26 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5404514 / 1 | 18053800897096 | Length 14 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5404518 / 1 | 18053800897119 | Length 18 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5404522 / 1 | 18053800897133 | Length 22 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5404524 / 1 | 18053800897140 | Length 24 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5404530 / 1 | 18053800897171 | Length 30 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5404534 / 1 | 18053800897195 | Length 34 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5404550 / 1 | 18053800897270 | Length 50 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5413026 / 1 | 18053800897362 | Length 26 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5413540 / 1 | 18053800897669 | Length 40 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5413560 / 1 | 18053800897737 | Length 60 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5415026 / 1 | 18053800897805 | Length 26 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5415032 / 1 | 18053800897836 | Length 32 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5431013 / 1 | 18053800896099 | Lumen/Inner Diameter 3.5 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5431023 / 1 | 18053800896198 | Lumen/Inner Diameter 5.0 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5431025 / 1 | 18053800896211 | Lumen/Inner Diameter 5.0 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5431029 / 1 | 18053800896259 | Lumen/Inner Diameter 5.0 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5431035 / 1 | 18053800896310 | Lumen/Inner Diameter 5.0 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5433001 / 1 | 18053800896433 | Lumen/Inner Diameter 3.5 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5433007 / 1 | 18053800896495 | Lumen/Inner Diameter 5.0 mm | On the market |
| JUNIORTHO PLATING SYSTEM 1 | 99-5434005L / 1 | 18053800896631 | Lumen/Inner Diameter 3.5 mm | On the market |
Similar devices
Other devices filed under FDA product code HRS (Plate, Fixation, Bone).
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- Arthrex® AR-8827-56S by Arthrex, Inc.
- STERNALOCK® BLU SYSTEM SP-2890 by BIOMET MICROFIXATION, INC
- 4845-38-04 00-4845-038-04 by Zimmer, Inc.
- Arthrex® AR-8935L-56 by Arthrex, Inc.
- ACUMED 7005-13005-S by ACUMED LLC
- APTUS CMC-I Fusion Plate System by Medartis AG
- ACUMED 71-0389 by ACUMED LLC
- A.L.P.S.® 8562-10-009 856210009 by Biomet Orthopedics, Inc.
- NCB®-PT 02.00024.093 by Zimmer, Inc.