# K261510: Signature™ ONE System

- Pathway: 510(k) (Special)
- Applicant: Orthosoft Inc. (d/b/a) Zimmer CAS
- Decided: Jun 4, 2026 after 28 days
- Product code: QHE (Shoulder Arthroplasty Implantation System)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K905070 (1991). 116 ancestors in all.
No later device cites it as a predicate yet.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K260104: Signature™ ONE System, Orthosoft Inc. (d/b/a) Zimmer CAS (2026) Summary page 5.

## Indications for use
The Signature™ ONE System is indicated, based on patient-specific radiological images with identifiable placement anatomical landmarks, to assist in pre-operative planning and/or intra-operative guiding of surgical instruments for shoulder replacement surgical procedures on patients not precluded from being radiologically scanned. The Signature™ ONE System is designed for use on a skeletally mature patient population. The targeted population has the same characteristics as the population that is suitable for the implants compatible with the Signature™ ONE System. The Signature™ ONE System is to be used with the glenoid components of the following shoulder implant systems in accordance with their indications and contraindications: Zimmer® Trabecular Metal Reverse Plus® Shoulder, Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, Comprehensive® Reverse Augmented Baseplates and Alliance® Glenoid System. The Signature™ ONE System pre-operative planning is also compatible with the humeral components of the following shoulder implant systems in accordance with their indications and contraindications: Comprehensive® Total Shoulder System, Comprehensive® Reverse Shoulder System, and Identity™ Shoulder System, and OsseoFit® Stemless Shoulder System. The Signature™ ONE System Guides and bone models are intended for single use only.

Source page: https://510kreport.com/device/K261510
Methodology: https://510kreport.com/methodology