510(k) · Cleared
ClearedSonoma Fibula Repair System
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 Jan 22, 2015 as substantially equivalent to K071944 (Acumed, LLC, 2007) and 1 other predicate after a 104-day review. Its family tree reaches back 3 generations to 1992. 10 later devices descend from it.
- Decided
- Jan 22, 2015
- Review
- 104 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913949 (1992). 5 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK913949 True/Flex Humerus, Ulna & Radius Intramed Rods SysApplied Osteo Systems, Inc. · 1992
- 2 generations backK031438 Acumed Small Bone Locking Rod System IIAcumed, LLC · 2003 · Recalled
- 1 generation backK071944 Acumed Small Bone Locking System IIAcumed, LLC · 2007
- This deviceK142945 Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc. · 2015
- Descendant · cites it directly · 9 of its ownK160069 Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc. · 2016
- Descendant · cites it directly · 4 of its ownK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
- Descendant · 2 generations on · 3 of its ownK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · Recalled
- Descendant · 2 generations on · 3 of its ownK173656 Arthrex FibuLock NailArthrex, Inc. · 2018
- Descendant · 3 generations on · 1 of its ownK212030 Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K160069Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc. · 2016 · cites it directly9descendants
- K172943Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017 · cites it directly4descendants
- K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · 2 generations on3descendants
- K173656Arthrex FibuLock NailArthrex, Inc. · 2018 · 2 generations on3descendants
- K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913949 | True/Flex Humerus, Ulna & Radius Intramed Rods Sys | Applied Osteo Systems, Inc. | 1992 | — |
| −2 | K031438 | Acumed Small Bone Locking Rod System II | Acumed, LLC | 2003 | 1 |
| −1 | K071944 | Acumed Small Bone Locking System II | Acumed, LLC | 2007 | — |
| 0 (this device) | K142945 | Sonoma Fibula Repair System | Sonoma Orthopedic Products, Inc. | 2015 | — |
| +1 | K160069 | Sonoma Fibula Repair System | Sonoma Orthopedics Products, Inc. | 2016 | — |
| +1 | K172943 | Flex-Thread Fibula Pin System | Intrafuse, LLC | 2017 | — |
| +2 | K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | Conventus Orthopaedics, LLC | 2021 | 2 |
| +2 | K173656 | Arthrex FibuLock Nail | Arthrex, Inc. | 2018 | — |
| +3 | K212030 | Flex-Thread™ Distal Fibula lntramedullary Nail System | Flower Orthopedics Corporation Dba Conventus Flower | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K071944 | Acumed Small Bone Locking System II Our reading of the summary gave K071994, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Acumed Small Bone Locking Rod System II”. | 2007 |
| * | K031438 | Acumed Small Bone Locking Rod System IISummary page 6…K142945 Page 2 of 2 Predicate Devices: K071994 Acumed Small Bone Locking Rod System II K031438 Acumed Small Bone Locking Rod System II Device Description: The Sonoma Fibula Repair System includes all implants… | 2003 |
What descends from it? (10)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K160069 (Sonoma Orthopedics Products, Inc., 2016) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K071944.
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. 2015, 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 Fibula Repair System is intended for use in the fixation of fibula fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142945 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142945: Sonoma Fibula Repair System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142945
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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