510(k) · Cleared
ClearedArthrex FibuLock Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 26, 2018 as substantially equivalent to K160069 (Sonoma Orthopedics Products, Inc., 2016) after a 239-day review. Its family tree reaches back 5 generations to 1992. 3 later devices descend from it.
- Decided
- Jul 26, 2018
- Review
- 239 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913949 (1992). 7 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK913949 True/Flex Humerus, Ulna & Radius Intramed Rods SysApplied Osteo Systems, Inc. · 1992
- 4 generations backK031438 Acumed Small Bone Locking Rod System IIAcumed, LLC · 2003 · Recalled
- 3 generations backK071944 Acumed Small Bone Locking System IIAcumed, LLC · 2007
- 2 generations backK142945 Sonoma Fibula Repair SystemSonoma Orthopedic Products, Inc. · 2015
- 1 generation backK160069 Sonoma Fibula Repair SystemSonoma Orthopedics Products, Inc. · 2016
- This deviceK173656 Arthrex FibuLock NailArthrex, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK252196 Arthrex FibuLock Nail SystemArthrex, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK250197 Estremo Fibular NailCitieffe S.R.L. · 2025
- Descendant · cites it directly · 0 of its ownK234128 Phantom Fibula Nail SystemParagon 28, Inc. · 2024 · Recalled
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913949 | True/Flex Humerus, Ulna & Radius Intramed Rods Sys | Applied Osteo Systems, Inc. | 1992 | — |
| −4 | K031438 | Acumed Small Bone Locking Rod System II | Acumed, LLC | 2003 | 1 |
| −3 | K071944 | Acumed Small Bone Locking System II | Acumed, LLC | 2007 | — |
| −2 | K142945 | Sonoma Fibula Repair System | Sonoma Orthopedic Products, Inc. | 2015 | — |
| −1 | K160069 | Sonoma Fibula Repair System | Sonoma Orthopedics Products, Inc. | 2016 | — |
| 0 (this device) | K173656 | Arthrex FibuLock Nail | Arthrex, Inc. | 2018 | — |
| +1 | K252196 | Arthrex FibuLock Nail System | Arthrex, Inc. | 2026 | — |
| +1 | K250197 | Estremo Fibular Nail | Citieffe S.R.L. | 2025 | — |
| +1 | K234128 | Phantom Fibula Nail System | Paragon 28, Inc. | 2024 | 1 |
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 |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (1)
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 |
|---|---|---|---|
| * | K160069 | Sonoma Fibula Repair SystemSummary page 4…ntramedullary and Accessories Product Code HSB Classification Name 21 CFR 888.3020: Intramedullary Fixation Rod Regulatory Class II Predicate Device K160069: Sonoma Fibula Repair System Purpose of This Special 510(k) premarket notification is submitted to obtain clearance fo… | 2016 |
What descends from it? (3)
3 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 26 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K252196 (Arthrex, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K160069.
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. 2018, 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 Arthrex FibuLock Nail is intended for use in the fixation of fibula fractures and osteotomies.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173656 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173656: Arthrex FibuLock Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173656
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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