# K130126: Signature Personalized Patient Care System - Glenoid Guide System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Aug 6, 2013 after 201 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K905070 (1991). 29 ancestors in all.
38 later devices descend from it; 2 cite it directly.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050897: Navipro Shoulder Software Module, Kinamed, Inc. (2005) Summary page 1.
- K111863: Signature Planner,Signature Guides, Materialise NV (2012) Summary page 1.

## Most influential descendants
- K143374: BLUEPRINT Patient Specific Instrumentation (2015), 31 descendants of its own
- K160555: BLUEPRINT Patient Specific Instrumentation (2016), 25 descendants of its own
- K162800: BLUEPRINT Patient Specific Instrumentation (2017), 23 descendants of its own
- K203315: BLUEPRINT™ Patient Specific Instrumentation (2021), 18 descendants of its own
- K190595: Signature ONE System (2019), 10 descendants of its own

## Indications for use
The Signature Personalized Patient Care System - Glenoid Guide System is intended to be used as a surgical instrument to assist in the positioning of glenoid components intra-operatively using anatomical landmarks of the shoulder that are identifiable on preoperative imaging scans. The Signature Personalized Patient Care System - Glenoid Guide System can be used in conjunction with the Comprehensive Total and Reverse Shoulder Systems (including the Modular Hybrid Glenoid, Bio-Modular Heads and Stems), and their respective components, which require placement of an initial center pin or hole to guide the associated system instruments. The Signature Glenoid Guide is intended for single use only.

Source page: https://510kreport.com/device/K130126
Methodology: https://510kreport.com/methodology