Home / 510(k) Clearances / K243610

510(k) K243610

APTUS Hand System; APTUS Elbow Dorsal Olecranon by Medartis AG — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2025
Date Received
November 22, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Fixation, Bone
Device Class
Class II
Regulation Number
888.3030
Review Panel
OR
Submission Type

Other clearances by Medartis AG

  • 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)
  • K202589 — APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, (November 6, 2020)
  • K193639 — APTUS® Foot 2.8-3.5 System (March 26, 2020)

Other clearances for product code HRS

  • K253906 — Xpert Hand (March 11, 2026)
  • K260069 — DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System (March 9, 2026)
  • K260353 — Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button (March 3, 2026)
  • K254054 — VOLT™ Ankle Trauma 2.7/3.5 Plating System; VOLT™ Calcaneus 2.7 Plating System (March 2, 2026)
  • K254249 — HKT Anatomical Locking Trauma System (February 27, 2026)
  • K252166 — RIB LINK™ Fixation System (February 26, 2026)
  • K253660 — KLS Martin Pure Pectus System (February 20, 2026)
  • K251732 — Wrist Fracture System (February 12, 2026)
  • K253713 — Arthrex Variable Angle (VA) Proximal Tibia Plating System (January 21, 2026)
  • K254002 — TriMed Volar Bearing Plates (VBEAL-13-7S); TriMed Volar Bearing Plates (VBEAR-13 (January 15, 2026)