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510(k) K252254

Osteotomy Wedge System by Sinaptic Surgical — Product Code PLF

K252254 is an FDA 510(k) premarket notification submitted by Sinaptic Surgical for the device "Osteotomy Wedge System". The FDA issued a decision of Substantially Equivalent on October 17, 2025. The device falls under product code PLF (Bone Wedge), a Class II device regulated under 21 CFR 888.3030.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2025
Date Received
July 21, 2025
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 for product code PLF

  • K252733 — ATLAS™ Expandable Osteotomy Wedge System (February 19, 2026)
  • 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)
  • K203445 — Trigon HA Stand-Alone Wedge Fixation System (December 21, 2020)

FDA data resources