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510(k) K251862

External Fixation Bone Distractor by Paragon 28, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2025
Date Received
June 17, 2025
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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  • 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)
  • K240259 — APEX 3D Total Ankle Replacement System (June 24, 2024)

Other clearances for product code KTT

  • K253291 — Excelsior System (January 20, 2026)
  • K253202 — Hoffmann LRF System (December 19, 2025)
  • K253613 — Monkey Rings External Ring Fixation 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)
  • 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)
  • K241563 — Extremity Medical External Fixation System (February 21, 2025)