# K120271: Artisan Space Maintenance System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: May 30, 2012 after 121 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K894844 (1990). 33 ancestors in all.
No later device cites it as a predicate yet.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100779: Sustain Space Maintenance System, Medtronic Sofamor Danek USA, Inc. (2010) Summary page 1.
- K110259: Architex Space Maintenance System, Medtronic Sofamor Danek USA, Inc. (2011) Summary page 1.

## Indications for use
The ARTISANTM Space Maintenance System is indicated for use as temporary implants to stabilize and support autograft, autograft extenders, allograft, and bone void fillers and/or fractured bone segments with or without bone plates or titanium mesh in bony defects of oral maxillofacial anatomy. The ARTISANTM Space Maintenance System is intended for temporary use in oral maxillofacial surgical reconstruction and dental regeneration procedures for maintaining space during bone grafting procedures and to support soft tissue until bone formation.

Source page: https://510kreport.com/device/K120271
Methodology: https://510kreport.com/methodology