510(k) · Cleared
ClearedArthrex FibuLock Nail System
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 Mar 5, 2026 as substantially equivalent to K173656 (Arthrex, Inc., 2018) and 2 other predicates after a 234-day review. Its family tree reaches back 7 generations to 1979.
- Decided
- Mar 5, 2026
- Review
- 234 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K792022 (1979). 45 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 5 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 4 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 3 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 2 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 1 generation backK201522 Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemArthrex, Inc. · 2020
- This deviceK252196 Arthrex FibuLock Nail SystemArthrex, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −6 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −5 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −4 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −3 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −2 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −1 | K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | Arthrex, Inc. | 2020 | — |
| 0 (this device) | K252196 | Arthrex FibuLock Nail System | Arthrex, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K173656 | Arthrex FibuLock NailSummary page 5…t Code HSB Classification Name 21 CFR 888.3020, Intramedullary Fixation Rod Regulatory Class II Primary Predicate Device K173656: Arthrex FibuLock Nail Additional Predicate Devices K160069: Sonoma Fibula Repair System Reference Devices K222267… | 2018 |
| * | K160069 | Sonoma Fibula Repair SystemSummary page 5…CFR 888.3020, Intramedullary Fixation Rod Regulatory Class II Primary Predicate Device K173656: Arthrex FibuLock Nail Additional Predicate Devices K160069: Sonoma Fibula Repair System Reference Devices K222267: Arthrex 2.4 mm Volar Distal Radius Plate System… | 2016 |
| * | K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant SystemSummary page 5…K221031: Arthrex DualCompression Hindfoot Nail System K203294: Arthrex Pilon Fusion System K201522: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System Purpose of Submission Thi… | 2020 |
| † | K222267 | Arthrex 2.4 mm Volar Distal Radius Plate System | 2022 |
| † | K230257 | Arthrex Intramedullary Nails | 2023 |
| † | K221031 | Arthrex DualCompression Hindfoot Fusion Nail Implant System | 2022 |
| † | K203294 | Arthrex Pilon Fusion System | 2021 |
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 47 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- 4 of the 45 ancestors have a recall of any class.
- 2 other devices also cite its predicate K173656.
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. 2026, 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 System is intended for use in the fixation of fibula fractures and osteotomies.
The Buttress Plate is intended for use with the FibuLock PRO Nail and Arthrex TightRope Syndesmosis Devices to support additional stabilization for fibula fractures. The Buttress Plate is designed for use with the FibuLock PRO Nail and TightRope Syndesmosis devices and may not be used as a stand-alone device.
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/K252196 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252196: Arthrex FibuLock Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252196
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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