Home / 510(k) Clearances / K212815

510(k) K212815

My3D® Personalized Pelvic Reconstruction by Onkos Surgical — Product Code LPH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 6, 2022
Date Received
September 3, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type

Other clearances by Onkos Surgical

  • K252920 — ELEOS™ Limb Salvage System with NanoCept® Technology (October 15, 2025)
  • DEN210058 — ELEOSx™ Limb Salvage System (April 5, 2024)
  • K223348 — My3D® Personalized Pelvic Reconstruction (January 30, 2023)
  • K211677 — ELEOS Limb Salvage System (July 28, 2021)
  • K203815 — ELEOS Limb Salvage System with BioGrip (June 9, 2021)
  • K203588 — ELEOS™ Limb Salvage System (February 5, 2021)
  • K203090 — ELEOS Limb Salvage System featuring BIOGRIP (December 11, 2020)
  • K180130 — ELEOS™ Bipolar Acetabular System (February 23, 2018)
  • K161520 — ELEOS Limb Salvage System (October 28, 2016)

Other clearances for product code LPH

  • K252623 — G7® Revision Acetabular System (February 4, 2026)
  • K251043 — Mpact 3D Metal Implants Extension – DMLS Technology (January 28, 2026)
  • K252067 — Velora Acetabular System (December 5, 2025)
  • K252846 — TaperSet™ Hip System (November 20, 2025)
  • K251833 — EMPOWR Acetabular® Liner Extension (November 12, 2025)
  • K251718 — ArTT Augments and Buttresses and Bone Screws (August 29, 2025)
  • K250989 — Stryker and Serf hip devices (July 25, 2025)
  • K243456 — ONVOY™ Acetabular System (June 6, 2025)
  • K242744 — Trinity EVO Acetabular Shell (June 5, 2025)
  • K242232 — Mpact 3D Metal Augments II (April 23, 2025)