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510(k) K260104

Signature™ ONE System by Orthosoft Inc. (d/b/a) Zimmer CAS — Product Code QHE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 2026
Date Received
January 13, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shoulder Arthroplasty Implantation System
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Intended to be used to assist in the implantation of a specific shoulder arthroplasty device or a set of specific shoulder arthroplasty devices. Indicated to include guiding alignment, making or establishing cuts, selecting, sizing, attaching, positioning or orienting implant components.

Other clearances by Orthosoft Inc. (d/b/a) Zimmer CAS

  • K251314 — Rosa® Knee System (November 13, 2025)
  • K242864 — ROSA® Knee System (October 18, 2024)

Other clearances for product code QHE

  • K251558 — Precision AI Surgical Planning System (PAI-SPS) (January 12, 2026)
  • K243509 — Archer PSI System (May 12, 2025)
  • K241470 — CORE Shoulder System (February 20, 2025)
  • K243955 — Precision AI Surgical Planning System (PAI-SPS) (January 21, 2025)
  • K242813 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (October 18, 2024)
  • K241097 — Arthrex Virtual Implant Positioning (VIP) System Software (October 2, 2024)
  • K233992 — Precision AI Surgical Planning System (PAI-SPS) (August 5, 2024)
  • K241143 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (May 22, 2024)
  • K232425 — Signature™ ONE System (December 12, 2023)
  • K233408 — Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase S (November 9, 2023)