ADI TiDAL Osteotomy Wedge
FDA 510(k) K191047 · Additive Device, Inc. (Adi) D/B/A Restor3D
510(k) numberK191047
Submission
- Device name
- ADI TiDAL Osteotomy Wedge
- Applicant
- Additive Device, Inc. (Adi) D/B/A Restor3D
Durham, NC, US - Received
- April 19, 2019
- Decision date
- November 5, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLF – Bone Wedge
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.
Other 510(k)s with product code PLF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252733 | ATLAS Expandable Osteotomy Wedge SystemPLF · Traditional | MiRus, LLC | 02/19/2026SE |
| K252254 | Osteotomy Wedge SystemPLF · Traditional | Sinaptic Surgical | 10/17/2025SE |
| K251791 | Auxano® Wedge Fixation SystemPLF · Traditional | Auxano Medical, LLC | 09/25/2025SE |
| K240461 | OsteoSinter® EVANS and COTTON wedges and related accessoriesPLF · Abbreviated | Ames Medical Prosthetic Solutions, S.A.U. | 12/06/2024SE |
| K243231 | Trigon PEEK HA WedgesPLF · Special | Nvision Biomedical Technologies | 11/08/2024SE |
| K234116 | Trigon Trigon HA Stand-Alone Wedge Fixation SystemPLF · Special | Nvision Biomedical Technologies | 01/26/2024SE |
| K231496 | TITAN 3-D Wedge SystemPLF · Traditional | Paragon 28, Inc. | 08/22/2023SE |
| K223226 | Trigon HA Stand-Alone Wedge Fixation SystemPLF · Special | Nvision Biomedical Technologies, Inc. | 12/01/2022SE |
| K220197 | Trigon HA Wedge Fixation SystemPLF · Special | Nvision Biomedical Technologies, Inc. | 02/23/2022SE |
| K201314 | Restor3d Utility WedgePLF · Traditional | Restor3D, Inc. | 06/17/2021SE |
More from Restor3D, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K191812 | ADI Cervical Interbody Fusion DeviceODP · Traditional | 10/24/2019SE |
Questions and answers
When was ADI TiDAL Osteotomy Wedge cleared by the FDA?
ADI TiDAL Osteotomy Wedge (K191047) received a 510(k) decision of Substantially Equivalent on November 5, 2019, 200 days after the submission was received.
What is the product code of K191047?
The FDA product code is PLF – Bone Wedge, a Class II (moderate risk) device regulated under 21 CFR 888.3030.