# K022821: Aragon Wiring System Wire Cartridge, Models I0007 Wire Cartridge, 22 Gauge, I0008 Wire Cartridge, 24 Gauge, I0009 Wire E

- Pathway: 510(k) (Traditional)
- Applicant: Ideatrics, Inc.
- Decided: Nov 15, 2002 after 81 days
- Product code: DZK (Wire, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Intraosseous Fixation Wire by Synthes: named in the summary without a submission number
- (no number) Intraosseous Fixation Wire by Biomet-Kirschner: named in the summary without a submission number
- (no number) Intraosseous Fixation Wire by Stryker Instruments: named in the summary without a submission number
- (no number) Intraosseous Fixation Wire by Dupuy International Ltd.: named in the summary without a submission number
- (no number) Intraosseous Fixation Wire by Zimmer, Inc.: named in the summary without a submission number
- (no number) Intraosseous Fixation Wire by Mathys Medical Ltd.: named in the summary without a submission number

## Most influential descendants
- K061271: Erch Arch Bar, Model 38-690-00 (2006), 13 descendants of its own
- K122313: Stryker Universal Smartlock Hybrid MMF System (2012), 10 descendants of its own
- K143336: Biomet Microfixation OmniMax MMF System (2015), 5 descendants of its own
- K141165: Matrixwave MMF System (2014), 4 descendants of its own
- K173320: KLS Martin L1 MMF System (2018), 2 descendants of its own

## Indications for use
This device is used in surgery for the application of wires to the jaws of adults and children. The device can be used to directly wire bony segments together, or for the application of arch bars to the teeth for stabilization of bony fragments or wiring the teeth together (maxillomandibular fixation).

Source page: https://510kreport.com/device/K022821
Methodology: https://510kreport.com/methodology