Home / 510(k) Clearances / K231257

510(k) K231257

Pangea Utility Plating System, Pangea Platform by Stryker GmbH — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 2023
Date Received
May 1, 2023
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 Stryker GmbH

  • K253640 — T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System (February 3, 2026)
  • K253202 — Hoffmann LRF System (December 19, 2025)
  • K251400 — T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System (August 20, 2025)
  • K250163 — T2 Alpha Femur Retrograde Nailing System (August 13, 2025)
  • K242445 — Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pan (October 6, 2024)
  • K233919 — VariAx 2 Distal Radius System (March 25, 2024)
  • K233741 — Hoffmann LRF System (December 21, 2023)
  • K230045 — HipCheck (September 29, 2023)
  • K231854 — 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with (September 20, 2023)
  • K231262 — Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating (August 18, 2023)

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)