Home / 510(k) Clearances / K202589

510(k) K202589

APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System by Medartis AG — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2020
Date Received
September 8, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

Other clearances by Medartis AG

  • K243610 — APTUS Hand System; APTUS Elbow Dorsal Olecranon (March 7, 2025)
  • K240613 — APTUS Elbow Dorsal Olecranon Plates (June 20, 2024)
  • K232105 — APTUS Foot System 2.8-3.5 (April 19, 2024)
  • K234062 — APTUS Hand Scaphoid Plates (March 21, 2024)
  • K232251 — APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Ext (November 3, 2023)
  • K232324 — StealthFix Intraosseous Fixation System (August 30, 2023)
  • K232144 — Sterile Products of the APTUS System (August 18, 2023)
  • K230971 — APTUS® 3.5 TriLock Straight Plates (June 2, 2023)
  • K223853 — Medartis APTUS® Ulna Plates (March 30, 2023)
  • K193639 — APTUS® Foot 2.8-3.5 System (March 26, 2020)

Other clearances for product code HWC

  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K252901 — Tyber Medical Trauma Screw (December 31, 2025)
  • K251555 — Ultra™ Compression Screw System (November 6, 2025)
  • K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (October 10, 2025)
  • K250536 — MetaFore Small Screw System (October 8, 2025)
  • K252758 — Cannulated Screw and Kirschner (K wire) System (October 2, 2025)
  • K252019 — CurvaFix Low Profile System (August 29, 2025)
  • K251382 — Phoenix Sinus Tarsi Stent System (August 27, 2025)
  • K250867 — Dunamis Screw and Suture Locking System (August 15, 2025)
  • K250251 — Eleganz Fusion Screw System (Fusion Screw System) (June 13, 2025)