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510(k) K232144

Sterile Products of the APTUS System by Medartis AG — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2023
Date Received
July 19, 2023
Clearance Type
Special
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

  • 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)
  • 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)
  • K193633 — APTUS® Ankle Trauma System 2.8/3.5 (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)