510(k) · Cleared
ClearedSonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy (X=Dia, Yyy=Length- in MM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sonoma Orthopedic Products, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Aug 19, 2011 as substantially equivalent to K081832 (Sonoma Orthopedic Products, Inc., 2008) and 1 other predicate after a 77-day review. Its family tree reaches back 3 generations to 1990.
- Decided
- Aug 19, 2011
- Review
- 77 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K903258 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK903258 Hagie PinOnyx Medical Corp. · 1990
- 2 generations backK991649 Depuy Rockwood Clavicle PinDepuy, Inc. · 1999
- 1 generation backK081832 Ensplintcmx Clavicle PinSonoma Orthopedic Products, Inc. · 2008
- This deviceK111550 Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac…Sonoma Orthopedic Products, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903258 | Hagie Pin | Onyx Medical Corp. | 1990 | — |
| −2 | K991649 | Depuy Rockwood Clavicle Pin | Depuy, Inc. | 1999 | — |
| −1 | K081832 | Ensplintcmx Clavicle Pin | Sonoma Orthopedic Products, Inc. | 2008 | — |
| 0 (this device) | K111550 | Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy… | Sonoma Orthopedic Products, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 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 HSB? 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 HSB device
- #1 K200869 Gamma3 Systemscore 19.8 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K081832 | Ensplintcmx Clavicle PinSummary page 1…Clavicle Pin Classification Name 888.3020 Intramnedullary fixation rod. Predicate Device .Sonoma Orthopedic Products, Inc. K081 832, EnsplintCMX, Depuy Rockwood Pin K991649 Description of device The Sonoma Fa… | 2008 |
| * | K991649 | Depuy Rockwood Clavicle PinSummary page 1…ary fixation rod. Predicate Device .Sonoma Orthopedic Products, Inc. K081 832, EnsplintCMX, Depuy Rockwood Pin K991649 Description of device The Sonoma FasTrac Clavicle Fracture Repair Devices ar… | 1999 |
| * | — | Ensplint CMX Named without a submission number |
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
- None of the 5 ancestors has a recall.
- 2 other devices also cite its predicate K081832.
How does its category compare?
All HSB devicesHSB Rod, Fixation, Intramedullary And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · HSB
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSB
106in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSB
18in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSB
2,911in 2025
MAUDE reports naming product code HSB, 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 | 8 | 68 | 0 | 162 |
| 2008 | 11 | 57 | 9 | 184 |
| 2009 | 18 | 86 | 81 | 334 |
| 2010 | 14 | 117 | 18 | 454 |
| 2011 | 16 | 78 | 2 | 662 |
| 2012 | 17 | 112 | 7 | 1,079 |
| 2013 | 18 | 105 | 14 | 1,773 |
| 2014 | 19 | 147 | 3 | 1,474 |
| 2015 | 22 | 111 | 3 | 1,671 |
| 2016 | 8 | 124 | 6 | 1,920 |
| 2017 | 23 | 119 | 66 | 1,447 |
| 2018 | 17 | 134 | 56 | 3,526 |
| 2019 | 13 | 132 | 6 | 2,517 |
| 2020 | 17 | 112 | 6 | 3,299 |
| 2021 | 10 | 94 | 2 | 4,111 |
| 2022 | 12 | 172 | 1 | 2,733 |
| 2023 | 11 | 162 | 1 | 2,219 |
| 2024 | 13 | 195 | 1 | 2,869 |
| 2025 | 15 | 106 | 18 | 2,911 |
| 2026 | 18 | 151 | 1 | — |
What is it indicated for?
The Sonoma FasTrac Clavicle Fracture Repair Device is intended to be used to repair an acute fracture, mal-union or non-union of the clavicle.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111550: Sonoma Fastrac Clavicle Fracture Repair Device Model Sonoma Fastrac Xxyyy (X=Dia, Yyy=Length- in MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111550
Report an extraction error
Are you the manufacturer?
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