510(k) · Cleared
ClearedFlex-Thread™ Distal Fibula lntramedullary Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flower Orthopedics Corporation Dba Conventus Flower · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jul 23, 2021 as substantially equivalent to K202858 (Conventus Orthopaedics, LLC, 2021) after a 24-day review. Its family tree reaches back 10 generations to 1996. 1 later device descends from it.
- Decided
- Jul 23, 2021
- Review
- 24 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K962823 (1996). 59 ancestors in all, the oldest K792022 (1979). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 6 generations between
- 3 generations backK102845 Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011
- 2 generations backK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
- 1 generation backK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · Recalled
- This deviceK212030 Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021
- Descendant · cites it directly · 0 of its ownK252961 Fusion FibFix NailFusion Orthopedics USA, LLC · 2026
Show all 10 generations
- Root · 10 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 9 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 8 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 7 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 6 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 5 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 4 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 3 generations backK102845 Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011
- 2 generations backK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
- 1 generation backK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · Recalled
- This deviceK212030 Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021
Most influential descendants
Showing 1 of 1 · See all- K252961Fusion FibFix NailFusion Orthopedics USA, LLC · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −9 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −8 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −7 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −6 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −5 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −4 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| −3 | K102845 | Mahe Fixation Plate and Screw System | Mahe Medical GmbH | 2011 | — |
| −2 | K172943 | Flex-Thread Fibula Pin System | Intrafuse, LLC | 2017 | — |
| −1 | K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | Conventus Orthopaedics, LLC | 2021 | 2 |
| 0 (this device) | K212030 | Flex-Thread™ Distal Fibula lntramedullary Nail System | Flower Orthopedics Corporation Dba Conventus Flower | 2021 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail SystemSummary page 4…21 CFR 807.92(a)(3) Predicate# Predicate Trade Name (Primary Predicate is listed first) Product Code 11<202858 1 1 Flex-Thread™ Distal Fibula lntramedullary Nail System 1 1 HSB… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252961 | Fusion FibFix Nail | 2026 | 0 |
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 25 years and passes through 10 companies; a new generation was cleared every 2.4 years on median.
- 12 of the 59 ancestors have a recall of any class.
- Of its descendants, K252961 (Fusion Orthopedics USA, LLC, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K202858.
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. 2021, 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 Flex-Thread™ Distal Fibula Intramedullary Nail System 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/K212030 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212030: Flex-Thread™ Distal Fibula lntramedullary Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212030
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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