510(k) · Cleared
Recalled · Class II · 2023Flex-ThreadTM Distal Fibula Intramedullary Nail System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conventus Orthopaedics, LLC · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jan 22, 2021 as substantially equivalent to K172943 (Intrafuse, LLC, 2017) after a 116-day review. Its family tree reaches back 9 generations to 1996. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 22, 2021
- Review
- 116 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 9 generations to K962823 (1996). 58 ancestors in all, the oldest K792022 (1979). 3 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 5 generations between
- 3 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 2 generations backK102845 Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011
- 1 generation backK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
- This deviceK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021
- Descendant · cites it directly · 1 of its ownK212030 Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021
- Descendant · 2 generations on · 0 of its ownK252961 Fusion FibFix NailFusion Orthopedics USA, LLC · 2026
- Descendant · cites it directly · 0 of its ownK222390 Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2022
Show all 9 generations
- Root · 9 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 8 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 7 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 6 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 5 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 4 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 3 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 2 generations backK102845 Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011
- 1 generation backK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
- This deviceK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021
Most influential descendants
Showing 3 of 3 · See all- K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021 · cites it directly1descendant
- K252961Fusion FibFix NailFusion Orthopedics USA, LLC · 2026 · 2 generations on0descendants
- K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −8 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −7 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −6 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −5 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −4 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −3 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| −2 | K102845 | Mahe Fixation Plate and Screw System | Mahe Medical GmbH | 2011 | — |
| −1 | K172943 | Flex-Thread Fibula Pin System | Intrafuse, LLC | 2017 | — |
| 0 (this device) | K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | Conventus Orthopaedics, LLC | 2021 | — |
| +1 | K212030 | Flex-Thread™ Distal Fibula lntramedullary Nail System | Flower Orthopedics Corporation Dba Conventus Flower | 2021 | — |
| +2 | K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | 2026 | — |
| +1 | K222390 | Flex-Thread™ Ulna Intramedullary Nail System | Flower Orthopedics Corporation Dba Conventus Flower | 2022 | — |
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 |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K172943 | Flex-Thread Fibula Pin SystemSummary page 4…20 Product Code HSB Legally Marketed Predicate Devices (21 CFR 807.92(a)(3)) Predicate # Predicate Trade Name Product Code K172943 Flex-Thread Fibula Pin HSB System Device Description Summary (21 CF… | 2017 |
What descends from it? (3)
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 29, 2023 | Class II | Z-0074-2024 | Under Investigation by firm | Device is breaking while in use, potential for patients to require a revision surgery. |
| Nov 2, 2021 | Class II | Z-0448-2022 | Device Design | Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 9 companies; a new generation was cleared every 2.4 years on median.
- 11 of the 58 ancestors have a recall of any class.
- Of its descendants, K212030 (Flower Orthopedics Corporation Dba Conventus Flower, 2021) has gone furthest, with 1 descendant of its own.
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 TM 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/K202858 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202858: Flex-ThreadTM Distal Fibula Intramedullary 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/K202858
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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