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510(k) K240461

OsteoSinter® EVANS and COTTON wedges and related accessories by Ames Medical Prosthetic Solutions, S.A.U. — Product Code PLF

K240461 is an FDA 510(k) premarket notification submitted by Ames Medical Prosthetic Solutions, S.A.U. for the device "OsteoSinter® EVANS and COTTON wedges and related accessories". The FDA issued a decision of Substantially Equivalent on December 6, 2024. 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
December 6, 2024
Date Received
February 16, 2024
Clearance Type
Abbreviated
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.

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  • 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