Home / 510(k) Clearances / K162241

510(k) K162241

TITAN 3-D™ Wedge System by Paragon 28 — Product Code PLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2017
Date Received
August 10, 2016
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 Paragon 28

  • K253591 — Phantom® Hindfoot TTC/TC Nail System (March 5, 2026)
  • K253613 — Monkey Rings External Ring Fixation System (December 19, 2025)
  • K252106 — External Fixation Mini Rail System (September 30, 2025)
  • K251862 — External Fixation Bone Distractor (August 11, 2025)
  • K250952 — Baby Gorilla®/Gorilla® Plating System (July 18, 2025)
  • K251850 — Phantom® Hindfoot TTC/TC Nail System (July 14, 2025)
  • K250641 — APEX 3D Total Ankle Replacement System (May 1, 2025)
  • K242452 — Monkey Bars Pin to Bar External Fixation System (November 1, 2024)
  • K234128 — Phantom Fibula Nail System (August 22, 2024)
  • K241864 — Grappler Interference Screw System (July 25, 2024)

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)