Home / 510(k) Clearances / K171858

510(k) K171858

Sidus Stem-Free Shoulder by Zimmer GmbH — Product Code PKC

K171858 is an FDA 510(k) premarket notification submitted by Zimmer GmbH for the device "Sidus Stem-Free Shoulder". The FDA issued a decision of Substantially Equivalent on December 18, 2017. The device falls under product code PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained), a Class II device regulated under 21 CFR 888.3660. Zimmer GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2017
Date Received
June 21, 2017
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 Zimmer GmbH

  • K260831 — Z1 Hip System (June 16, 2026)
  • K261683 — Augment Off-Axis Instrument System (June 16, 2026)
  • K251840 — Zimmer® Persona® Personalized Knee System (May 28, 2026)
  • K260182 — Avenir® Müller Stem; Avenir Complete™ Hip System (April 27, 2026)
  • K253592 — Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity H (April 13, 2026)
  • K253566 — Affixus Retrograde Femoral Nailing System (March 12, 2026)
  • K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (March 9, 2026)
  • K252623 — G7® Revision Acetabular System (February 4, 2026)
  • K251098 — Identity Revision Humeral Stems (August 11, 2025)
  • K251906 — Z1 Hip System (July 18, 2025)

Other clearances for product code PKC

  • K254154 — FX V135 EASYTECH® Shoulder System (May 1, 2026)
  • 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)
  • K203108 — Ignite Stemless Anatomic Shoulder System (July 16, 2021)

FDA data resources