510(k) · Cleared
ClearedFusion FibFix Nail
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fusion Orthopedics USA, LLC · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 18, 2026 as substantially equivalent to K212030 (Flower Orthopedics Corporation Dba Conventus Flower, 2021) and 1 other predicate after a 183-day review. Its family tree reaches back 11 generations to 1996.
- Decided
- Mar 18, 2026
- Review
- 183 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K962823 (1996). 60 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 11 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 7 generations between
- 3 generations backK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
- 2 generations backK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · Recalled
- 1 generation backK212030 Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021
- This deviceK252961 Fusion FibFix NailFusion Orthopedics USA, LLC · 2026
Show all 11 generations
- Root · 11 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 10 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 9 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 8 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 7 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 6 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 5 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 4 generations backK102845 Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011
- 3 generations backK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
- 2 generations backK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · Recalled
- 1 generation backK212030 Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021
- This deviceK252961 Fusion FibFix NailFusion Orthopedics USA, LLC · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −10 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −9 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −8 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −7 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −6 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −5 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| −4 | K102845 | Mahe Fixation Plate and Screw System | Mahe Medical GmbH | 2011 | — |
| −3 | K172943 | Flex-Thread Fibula Pin System | Intrafuse, LLC | 2017 | — |
| −2 | K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | Conventus Orthopaedics, LLC | 2021 | 2 |
| −1 | K212030 | Flex-Thread™ Distal Fibula lntramedullary Nail System | Flower Orthopedics Corporation Dba Conventus Flower | 2021 | — |
| 0 (this device) | K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K212030 | Flex-Thread™ Distal Fibula lntramedullary Nail SystemSummary page 5…edic Primary Predicate: Conventus Flower: Flex-Thread™ Distal Fibula Intramedullary Nail Predicate System (K212030) Devices Additional Predicate: Acumed LLC: Small Bone Locking Rod System II (K031438) Referen… | 2021 |
| * | K031438 | Acumed Small Bone Locking Rod System IISummary page 5…il Predicate System (K212030) Devices Additional Predicate: Acumed LLC: Small Bone Locking Rod System II (K031438) Reference Fusion Orthopedics USA, LLC: Small Bone Plating System (K211843) Devices… | 2003 |
| † | K211843 | PolyLock Plating System | 2022 |
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 30 years and passes through 11 companies; a new generation was cleared every 2.4 years on median.
- 12 of the 60 ancestors have a recall of any class.
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 Fusion FibFix 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/K252961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252961: Fusion FibFix Nail.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252961
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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