Home / 510(k) Clearances / K253613

510(k) K253613

Monkey Rings External Ring Fixation System by Paragon 28, Inc. — Product Code KTT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 2025
Date Received
November 18, 2025
Clearance Type
Special
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.

  • K253591 — Phantom® Hindfoot TTC/TC Nail System (March 5, 2026)
  • 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)
  • 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)
  • 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)
  • K241563 — Extremity Medical External Fixation System (February 21, 2025)