510(k) · Cleared
ClearedSprytie, Models ST001, ST002 and ST003
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Russell B. Walther · DZK Wire, Fixation, Intraosseous
Cleared on Apr 2, 2010 as substantially equivalent to K022821 (Ideatrics, Inc., 2002) and 1 other predicate after a 227-day review. Its family tree reaches back 4 generations to 1982. 1 later device descends from it.
- Decided
- Apr 2, 2010
- Review
- 227 days
- Class
- Class II
- Product code
- DZK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K820944 (1982). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK820944 Dental Arch BarUnisplint Corp. · 1982
- 3 generations backK991004 Synthes Quick Lock Imf SystemSynthes (Usa) · 1999
- 2 generations backK031207 Safety Release Arch Bar KitCasey Surgical, LLC · 2003
- 1 generation backK061271 Erch Arch Bar, Model 38-690-00KLS-Martin L.P. · 2006
- This deviceK092530 Sprytie, Models ST001, ST002 and ST003Russell B. Walther · 2010
- Descendant · cites it directly · 0 of its ownK183113 DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
Most influential descendants
Showing 1 of 1 · See all- K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K820944 | Dental Arch Bar | Unisplint Corp. | 1982 | — |
| −3 | K991004 | Synthes Quick Lock Imf System | Synthes (Usa) | 1999 | — |
| −2 | K031207 | Safety Release Arch Bar Kit | Casey Surgical, LLC | 2003 | — |
| −1 | K061271 | Erch Arch Bar, Model 38-690-00 | KLS-Martin L.P. | 2006 | — |
| 0 (this device) | K092530 | Sprytie, Models ST001, ST002 and ST003 | Russell B. Walther | 2010 | — |
| +1 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DZK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022821 | Aragon Wiring System Wire Cartridge, Models I0007 Wire Cartridge, 22 Gauge, I0008 Wire…Summary page 1…duct Code: DZK Predicate Devices 807.92(a)(3) Predicate Device #1: Aragon Wiring System, K022821 Predicate Device #2: Erich Arch Bar, K061271 Device Description… | 2002 |
| * | K061271 | Erch Arch Bar, Model 38-690-00Summary page 1…807.92(a)(3) Predicate Device #1: Aragon Wiring System, K022821 Predicate Device #2: Erich Arch Bar, K061271 Device Description 807.92(a)(4) The Sprytie"' isa 25, 26, or 27 gauge annealed… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K183113 (Synthes (USA) Products, LLC, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K022821.
How does its category compare?
All DZK devicesDZK Wire, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · DZK
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · DZK
Too few DZK 510(k)s in any year since 2007 to give a median.
Recalls per year · DZK
No recall names DZK since 2007.
Adverse event reports per year · DZK
2in 2021
MAUDE reports naming product code DZK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 2 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 9 |
| 2013 | 0 | — | 0 | 6 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092530 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092530: Sprytie, Models ST001, ST002 and ST003.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092530
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026