JuniOrtho Plating System
FDA 510(k) K213572 · Orthofix Srl
510(k) numberK213572
Submission
- Device name
- JuniOrtho Plating System
- Applicant
- Orthofix Srl
Bussolengo, IT - Received
- November 10, 2021
- Decision date
- January 18, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
More from Arthrex, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260146 | Fitbone® Transport and Lengthening SystemHSB · Traditional | 05/19/2026SE |
| K253991 | Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional | 05/08/2026SE |
| K250112 | FitboneTM TrochantericHSB · Traditional | 04/10/2025SE |
| K242270 | OrthoNext Platform SystemQIH · Traditional | 12/19/2024SE |
| K242861 | TrueLok ElevateKTT · Traditional | 12/03/2024SE |
| K233867 | Fitbone TrochantericHSB · Traditional | 06/18/2024SE |
| K240749 | PILLAR SA Ti Spacer System (82-XXX)MAX · Traditional | 05/28/2024SE |
| K232648 | RODEO Telescopic NailHSB · Traditional | 05/03/2024SE |
| K232169 | FITBONE® Transport and Lengthening SystemHSB · Traditional | 03/22/2024SE |
| K212044 | TrueLok EvoKTT · Traditional | 11/05/2021SE |
Questions and answers
When was JuniOrtho Plating System cleared by the FDA?
JuniOrtho Plating System (K213572) received a 510(k) decision of Substantially Equivalent on January 18, 2022, 69 days after the submission was received.
What is the product code of K213572?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.