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510(k) K242452

Monkey Bars Pin to Bar External Fixation System by Paragon 28, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2024
Date Received
August 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Paragon 28, Inc.

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  • 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)
  • K234128 — Phantom Fibula Nail System (August 22, 2024)
  • K241864 — Grappler Interference Screw System (July 25, 2024)
  • K240259 — APEX 3D Total Ankle Replacement System (June 24, 2024)

Other clearances for product code KTT

  • K253291 — Excelsior System (January 20, 2026)
  • K253613 — Monkey Rings External Ring Fixation System (December 19, 2025)
  • K253202 — Hoffmann LRF System (December 19, 2025)
  • K252555 — Medusa Orthopedics Boa External Fixation System (November 25, 2025)
  • K252625 — The Response Ortho Smart Fixator - Hexapod System (November 20, 2025)
  • K252106 — External Fixation Mini Rail System (September 30, 2025)
  • K251862 — External Fixation Bone Distractor (August 11, 2025)
  • K250472 — SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (August 8, 2025)
  • K251128 — Extremity Medical External Fixation System (May 7, 2025)
  • K243798 — Orthex External Fixation System (March 7, 2025)