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510(k) K191047

ADI TiDAL Osteotomy Wedge by Additive Device, Inc. (Adi) D/B/A Restor3D — Product Code PLF

K191047 is an FDA 510(k) premarket notification submitted by Additive Device, Inc. (Adi) D/B/A Restor3D for the device "ADI TiDAL Osteotomy Wedge". The FDA issued a decision of Substantially Equivalent on November 5, 2019. The device falls under product code PLF (Bone Wedge), a Class II device regulated under 21 CFR 888.3030. Additive Device, Inc. (Adi) D/B/A Restor3D has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2019
Date Received
April 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Wedge
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Intended to be used with ancillary fixation for opening wedge osteotomies or fusion in the ankle, foot, proximal tibia.

Other clearances by Additive Device, Inc. (Adi) D/B/A Restor3D

  • K191812 — ADI Cervical Interbody Fusion Device (October 24, 2019)

Other clearances for product code PLF

  • K252733 — ATLAS™ Expandable Osteotomy Wedge System (February 19, 2026)
  • K252254 — Osteotomy Wedge System (October 17, 2025)
  • K251791 — Auxano® Wedge Fixation System (September 25, 2025)
  • K240461 — OsteoSinter® EVANS and COTTON wedges and related accessories (December 6, 2024)
  • K243231 — Trigon PEEK HA Wedges (November 8, 2024)
  • K234116 — Trigon Trigon HA Stand-Alone Wedge Fixation System (January 26, 2024)
  • K231496 — TITAN 3-D Wedge System (August 22, 2023)
  • K223226 — Trigon™ HA Stand-Alone Wedge Fixation System (December 1, 2022)
  • K220197 — Trigon HA Wedge Fixation System (February 23, 2022)
  • K201314 — Restor3d Utility Wedge (June 17, 2021)

FDA data resources