510(k) · Cleared
ClearedSteriTrak
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arbutus Medical, Inc. · JEC Component, Traction, Invasive
Cleared on Apr 23, 2021 as substantially equivalent to K960385 (Depuy, Inc., 1996) and 1 other predicate after a 134-day review. Its family tree reaches back 1 generation to 1976.
- Decided
- Apr 23, 2021
- Review
- 134 days
- Class
- Class II
- Product code
- JEC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K761088 (1976). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK761088 Depuy Modified Skeletal Traction PinDepuy, Inc. · 1976
- This deviceK203605 SteriTrakArbutus Medical, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K761088 | Depuy Modified Skeletal Traction Pin | Depuy, Inc. | 1976 | — |
| 0 (this device) | K203605 | SteriTrak | Arbutus Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 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 JEC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JEC device
- #1 K193256 Anjon Bremer Halo Systemscore 3.2 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K960385 | Sterile Kirschner Wires and Steinmann PinsSummary page 4…JEC (Component, Traction, Invasive) Classification: 11 Panel: Orthopedic Primary Predicate Device: K960385 - Sterile Kirschner Wires and Steinmann Pins Predicate Device: K761088 - Modified Skeletal Traction Pin Device D… | 1996 |
| * | K761088 | Depuy Modified Skeletal Traction PinSummary page 4…11 Panel: Orthopedic Primary Predicate Device: K960385 - Sterile Kirschner Wires and Steinmann Pins Predicate Device: K761088 - Modified Skeletal Traction Pin Device Description: SteriTrak TM… | 1976 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
- 16 other devices also cite its predicate K960385.
How does its category compare?
All JEC devicesJEC Component, Traction, Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · JEC
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · JEC
Too few JEC 510(k)s in any year since 2007 to give a median.
Recalls per year · JEC
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEC
2in 2025
MAUDE reports naming product code JEC, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 9 |
| 2009 | 1 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 13 |
| 2011 | 1 | — | 0 | 15 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 10 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 1 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 2 | — | 1 | 2 |
| 2019 | 1 | — | 1 | 3 |
| 2020 | 1 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 26 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SteriTrak is indicated for implantation through the skin and bone so that traction may be applied to the skeletal system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203605 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203605: SteriTrak.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203605
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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