Cleared Special

K261510 - Signature™ ONE System

K261510 is an FDA 510(k) clearance for Signature ONE System, manufactured by Orthosoft Inc. (d/b/a) Zimmer CAS. The device is a Class 2 Orthopedic device with product code QHE cleared through the Special 510(k) pathway after a 28-day FDA review.

K261510 · Orthosoft Inc. (d/b/a) Zimmer CAS · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
28d
Days
Class 2
Risk

K261510 is an FDA 510(k) clearance for the Signature™ ONE System. Classified as Shoulder Arthroplasty Implantation System (product code QHE), Class II - Special Controls.

Submitted by Orthosoft Inc. (d/b/a) Zimmer CAS (Montreal, CA). The FDA issued a Cleared decision on June 4, 2026 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K261510

510(k) Number K261510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2026
Decision Date June 04, 2026
Days to Decision 28 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

QHE Device Classification - Class 2, Special Controls

Product Code QHE Shoulder Arthroplasty Implantation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - QHE Shoulder Arthroplasty Implantation System

All 25
Devices cleared under the same product code (QHE) and FDA review panel - the closest regulatory comparables to K261510.
Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner
K260802 · Materialise NV · Jun 2026
Signature™ ONE System
K260104 · Orthosoft Inc. (d/b/a) Zimmer CAS · Feb 2026
Precision AI Surgical Planning System (PAI-SPS)
K251558 · Precision AI Pty, Ltd. · Jan 2026
Archer PSI System
K243509 · 3D-Side · May 2025
CORE Shoulder System
K241470 · LinkBio Corp. · Feb 2025
Precision AI Surgical Planning System (PAI-SPS)
K243955 · Precision AI Pty, Ltd. · Jan 2025
K261510 · Signature™ ONE System
Download PDF FDA Summary Orthosoft Inc. (d/b/a…