# K092530: Sprytie, Models ST001, ST002 and ST003

- Pathway: 510(k) (Traditional)
- Applicant: Russell B. Walther
- Decided: Apr 2, 2010 after 227 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
Longest line of descent: 4 generations back to K820944 (1982). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022821: Aragon Wiring System Wire Cartridge, Models I0007 Wire Cartridge, 22 Gauge, I0008 Wire Cartridge, 24 Gauge, I0009 Wire E, Ideatrics, Inc. (2002) Summary page 1.
- K061271: Erch Arch Bar, Model 38-690-00, KLS-Martin L.P. (2006) Summary page 1.

## Most influential descendants
- K183113: DePuy Synthes Maxillofacial Portfolio - MR Conditional (2019), 0 descendants of its own

## Indications for use
Sprytie'TM wires are indicated for use in the jaws in adults and children to directly wire bony segments together, for the fixation of arch bars or splints to the teeth, for stabiliiation of bony segments, or for wiring the teeth together (maxillomandibular fixation).

Source page: https://510kreport.com/device/K092530
Methodology: https://510kreport.com/methodology