510(k) · Cleared
ClearedFlex-Thread Fibula Pin System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intrafuse, LLC · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Oct 30, 2017 as substantially equivalent to K102845 (Mahe Medical GmbH, 2011) and 5 other predicates after a 34-day review. Its family tree reaches back 8 generations to 1996. 4 later devices descend from it.
- Decided
- Oct 30, 2017
- Review
- 34 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 8 generations to K962823 (1996). 57 ancestors in all, the oldest K792022 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK962823 Synthes Sterile 3.0 MM Cannulated Screw and Threaded WasherSynthes (Usa) · 1996
- 7 generations backK993762 I.CO.S ScrewNew Deal, S.A. · 2000
- 6 generations backK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- 5 generations backK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- 4 generations backK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- 3 generations backK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- 2 generations backK083912 Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins…Treu-Instrumente GmbH · 2009
- 1 generation backK102845 Mahe Fixation Plate and Screw SystemMahe Medical GmbH · 2011
- This deviceK172943 Flex-Thread Fibula Pin SystemIntrafuse, LLC · 2017
- Descendant · cites it directly · 3 of its ownK202858 Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · Recalled
- Descendant · 2 generations on · 1 of its ownK212030 Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021
- Descendant · 3 generations on · 0 of its ownK252961 Fusion FibFix NailFusion Orthopedics USA, LLC · 2026
- Descendant · 2 generations on · 0 of its ownK222390 Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2022
Most influential descendants
Showing 4 of 4 · See all- K202858Flex-ThreadTM Distal Fibula Intramedullary Nail SystemConventus Orthopaedics, LLC · 2021 · cites it directly3descendants
- K212030Flex-Thread™ Distal Fibula lntramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2021 · 2 generations on1descendant
- K252961Fusion FibFix NailFusion Orthopedics USA, LLC · 2026 · 3 generations on0descendants
- K222390Flex-Thread™ Ulna Intramedullary Nail SystemFlower Orthopedics Corporation Dba Conventus Flower · 2022 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K962823 | Synthes Sterile 3.0 MM Cannulated Screw and Threaded Washer | Synthes (Usa) | 1996 | — |
| −7 | K993762 | I.CO.S Screw | New Deal, S.A. | 2000 | — |
| −6 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| −5 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| −4 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| −3 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| −2 | K083912 | Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins | Treu-Instrumente GmbH | 2009 | — |
| −1 | K102845 | Mahe Fixation Plate and Screw System | Mahe Medical GmbH | 2011 | — |
| 0 (this device) | K172943 | Flex-Thread Fibula Pin System | Intrafuse, LLC | 2017 | — |
| +1 | K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | Conventus Orthopaedics, LLC | 2021 | 2 |
| +2 | K212030 | Flex-Thread™ Distal Fibula lntramedullary Nail System | Flower Orthopedics Corporation Dba Conventus Flower | 2021 | — |
| +3 | K252961 | Fusion FibFix Nail | Fusion Orthopedics USA, LLC | 2026 | — |
| +2 | 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 | 2 | 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? (6)
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 |
|---|---|---|---|
| * | K102845 | Mahe Fixation Plate and Screw SystemSummary page 4…of a Fibula, and cortical screws to further enhance stability and fixation of the Fibula. Predicate Devices: The Mahe Medical GmbH Mahe Fixation Plate and Screw System (K102845), the Sonoma Orthopedics Products, Inc. Sonoma Fibula Repair System (K142945, K160069) and the Acumed, LLC Acumed Small Bone IM N… | 2011 |
| * | K142945 | Sonoma Fibula Repair SystemSummary page 4…the Fibula. Predicate Devices: The Mahe Medical GmbH Mahe Fixation Plate and Screw System (K102845), the Sonoma Orthopedics Products, Inc. Sonoma Fibula Repair System (K142945, K160069) and the Acumed, LLC Acumed Small Bone IM Nail System (K143276, K071994, K031438) serve as the predicate devices.… | 2015 |
| * | K160069 | Sonoma Fibula Repair SystemSummary page 4…la. Predicate Devices: The Mahe Medical GmbH Mahe Fixation Plate and Screw System (K102845), the Sonoma Orthopedics Products, Inc. Sonoma Fibula Repair System (K142945, K160069) and the Acumed, LLC Acumed Small Bone IM Nail System (K143276, K071994, K031438) serve as the predicate devices.… | 2016 |
| * | K143276 | Acumed Small Bone IM Nail SystemSummary page 4…te and Screw System (K102845), the Sonoma Orthopedics Products, Inc. Sonoma Fibula Repair System (K142945, K160069) and the Acumed, LLC Acumed Small Bone IM Nail System (K143276, K071994, K031438) serve as the predicate devices.… | 2015 |
| * | K071944 | Acumed Small Bone Locking System II Our reading of the summary gave K071994, which is not a number in FDA’s lists. Corrected to the only number one digit away in this product code whose FDA name shares the summary’s words. | 2007 |
| * | K031438 | Acumed Small Bone Locking Rod System IISummary page 4…m (K102845), the Sonoma Orthopedics Products, Inc. Sonoma Fibula Repair System (K142945, K160069) and the Acumed, LLC Acumed Small Bone IM Nail System (K143276, K071994, K031438) serve as the predicate devices.… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202858 | Flex-ThreadTM Distal Fibula Intramedullary Nail System | 2021 | 3 |
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 21 years and passes through 8 companies; a new generation was cleared every 2.4 years on median.
- 11 of the 57 ancestors have a recall of any class.
- Of its descendants, K202858 (Conventus Orthopaedics, LLC, 2021) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K102845.
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. 2017, 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 Fibula Pin System is intended for use in the fixation of fibula fractures and osteotomies.
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/K172943 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172943: Flex-Thread Fibula Pin System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172943
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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