Signature ONE System— 510(k) K260104
Substantially EquivalentOrthosoft Inc. (d/b/a) Zimmer CAS
FDA 510(k) clearance K260104 for Signature ONE System, Substantially Equivalent on 2026-02-04. Applicant: Orthosoft Inc. (d/b/a) Zimmer CAS. Device class: 2.
Summary
Orthosoft, doing business as Zimmer CAS, filed the Signature ONE System under product code QHE, shoulder arthroplasty implantation system. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 888.3660. Orthopedic is both the classification panel and the review panel. It came in as a Special 510(k).
Orthosoft filed from Montreal, Canada. FDA found it substantially equivalent 22 calendar days after receipt (January 13 to February 4, 2026).
Clearance details
- Applicant
- Orthosoft Inc. (d/b/a) Zimmer CAS
- Product code
- Product code QHE
- Device class
- Class 2
- Regulation
- 21 CFR 888.3660
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Montreal, CA
Recent devices under product code QHE
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