# K031207: Safety Release Arch Bar Kit

- Pathway: 510(k) (Traditional)
- Applicant: Casey Surgical, LLC
- Decided: Jul 15, 2003 after 90 days
- Product code: DYX (Lock, Wire, And Ligature, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.4600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K820944 (1982). 3 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991004: Synthes Quick Lock Imf System, Synthes (Usa) (1999) Summary page 1.
- K820944: Dental Arch Bar, Unisplint Corp. (1982)

## 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
Casey Surgical Safety Release TM Arch Bar Kit is indicated for use in intermaxillary and maxillo-mandibular fixation.

Source page: https://510kreport.com/device/K031207
Methodology: https://510kreport.com/methodology