Home / 510(k) Clearances / K203108

510(k) K203108

Ignite Stemless Anatomic Shoulder System by Ignite Orthopedics, LLC — Product Code PKC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 16, 2021
Date Received
October 15, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Replacement of the humeral head for total anatomic shoulder arthroplasty

Other clearances by Ignite Orthopedics, LLC

  • K202716 — Ignite Anatomic Shoulder System (May 20, 2021)
  • K183618 — Revolution Radial Head (May 17, 2019)

Other clearances for product code PKC

  • K252129 — AETOS Shoulder System Stemless Humeral Prosthesis (October 3, 2025)
  • K243248 — INHANCE INTACT™ (December 23, 2024)
  • K241873 — OsseoFit Stemless Shoulder System (December 11, 2024)
  • K240716 — AETOS Shoulder System Stemless Humeral Prosthesis (November 20, 2024)
  • K221758 — SMR Stemless Anatomic (March 17, 2023)
  • K220418 — Tornier Perform Humeral System – Stemless (September 14, 2022)
  • K213615 — Shoulder Innovations Total Shoulder System (March 11, 2022)
  • K212683 — GLOBAL ICON Stemless Shoulder System (January 19, 2022)
  • K201391 — Easytech® Anatomical Shoulder System (February 16, 2021)
  • K203100 — Arthrex Eclipse Titanium Humeral Head (November 20, 2020)