Home / 510(k) Clearances / K180239

510(k) K180239

Additive Orthopaedics Patient Specific 3D Printed Bone Segments by Additive Orthopaedics, LLC — Product Code HRS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2018
Date Received
January 29, 2018
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 Additive Orthopaedics, LLC

  • K211076 — Patient Specific Marking Guides (June 28, 2022)
  • K183011 — Additive Orthopaedics Patient Specific 3D Locking Lattice Plates (January 10, 2019)
  • K163593 — Additive Orthopaedics Bunion System (June 20, 2017)
  • K170214 — Additive Orthopaedics Locking Lattice Plate (April 13, 2017)
  • K153207 — Additive Orthopaedics Bone Wedge System (September 7, 2016)
  • K160264 — Additive Orthopaedics Hammertoe Correction System (June 1, 2016)

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)