# K232425: Signature™ ONE System

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft Inc. (D/B/A) Zimmer Cas)
- Decided: Dec 12, 2023 after 123 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: 14 generations back to K905070 (1991). 114 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 117 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212560: Signature™ ONE System, Orthosoft Inc (D/B/A Zimmer Cas) (2021) Summary page 5.
- K211359: Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation, Tornier, Inc. (2021) Summary page 5.

## Most influential descendants
- K260104: Signature™ ONE System (2026), 1 descendant of its own
- K261510: Signature™ ONE System (2026), 0 descendants of its own

## 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. The Signature™ ONE System Guides and bone models are intended for single use only.

Source page: https://510kreport.com/device/K232425
Methodology: https://510kreport.com/methodology