# K200615: Signature ONE System

- Pathway: 510(k) (Traditional)
- Applicant: Orthosoft Inc (D/B/A Zimmer Cas)
- Decided: Jun 5, 2020 after 88 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: 11 generations back to K905070 (1991). 67 ancestors in all.
8 later devices descend from it; 1 cites it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190595: Signature ONE System, Orthosoft Inc (D/B/A Zimmer Cas) (2019) Summary page 5.
- K192074: Signature ONE System, Orthosoft Inc (D/B/A Zimmer Cas) (2019) Summary page 5.

## Most influential descendants
- K212560: Signature™ ONE System (2021), 7 descendants of its own
- K222007: Arthrex Virtual Implant Positioning (VIP) System (2023), 3 descendants of its own
- K232425: Signature™ ONE System (2023), 2 descendants of its own
- K260104: Signature™ ONE System (2026), 1 descendant of its own
- K230904: Arthrex Virtual Implant Positioning (VIP) System (2023), 1 descendant 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 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 Guides and bone models are intended for single use only.

Source page: https://510kreport.com/device/K200615
Methodology: https://510kreport.com/methodology