510(k) K232425

Signature ONE System by Orthosoft Inc. (D/B/A) Zimmer Cas) — Product Code QHE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 12, 2023
Date Received: August 11, 2023
Clearance Type: Traditional
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 for product code QHE

K260104 — Signature ONE System (February 4, 2026)
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)
K233408 — Materialise Shoulder System, Materialise Shoulder Guide and Models, SurgiCase S (November 9, 2023)