# K110259: Architex Space Maintenance System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Apr 13, 2011 after 75 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: 8 generations back to K894844 (1990). 32 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080074: Ace Surigical Tru-Fix Implant System, Model 454-180X-XX, Ace Surgical Supply Co., Inc. (2008) Summary page 2.
- K100779: Sustain Space Maintenance System, Medtronic Sofamor Danek USA, Inc. (2010) Summary page 2.

## Most influential descendants
- K120271: Artisan Space Maintenance System (2012), 0 descendants of its own

## Indications for use
The ARCHITEX 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.

Source page: https://510kreport.com/device/K110259
Methodology: https://510kreport.com/methodology