510(k) · Cleared
ClearedFITBONE® Transport and Lengthening System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix Srl · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 22, 2024 as substantially equivalent to K201567 (Nuvasive Specialized Orthopedics, Inc., 2020) and 1 other predicate after a 245-day review. Its family tree reaches back 9 generations to 1983. 2 later devices descend from it.
- Decided
- Mar 22, 2024
- Review
- 245 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K831576 (1983). 19 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 5 generations between
- 3 generations backK131490 Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- 2 generations backK163368 Fitbone TaaWittenstein Intens GmbH · 2017
- 1 generation backK203399 Fitbone (R) TaaWittenstein Intens GmbH · 2021
- This deviceK232169 FITBONE® Transport and Lengthening SystemOrthofix Srl · 2024
- Descendant · cites it directly · 0 of its ownK260146 Fitbone® Transport and Lengthening SystemOrthofix Srl · 2026
- Descendant · cites it directly · 0 of its ownK253991 Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System…Orthofix Srl · 2026
Show all 9 generations
- Root · 9 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 8 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 7 generations backK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
- 6 generations backK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
- 5 generations backK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
- 4 generations backK113219 Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2012
- 3 generations backK131490 Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- 2 generations backK163368 Fitbone TaaWittenstein Intens GmbH · 2017
- 1 generation backK203399 Fitbone (R) TaaWittenstein Intens GmbH · 2021
- This deviceK232169 FITBONE® Transport and Lengthening SystemOrthofix Srl · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −8 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −7 | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthodyne, Inc. | 2001 | 1 |
| −6 | K031219 | Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthofix, Inc. | 2003 | 1 |
| −5 | K101997 | Ellipse Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2011 | 2 |
| −4 | K113219 | Ellipse Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2012 | — |
| −3 | K131490 | Ellipse Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | — |
| −2 | K163368 | Fitbone Taa | Wittenstein Intens GmbH | 2017 | — |
| −1 | K203399 | Fitbone (R) Taa | Wittenstein Intens GmbH | 2021 | — |
| 0 (this device) | K232169 | FITBONE® Transport and Lengthening System | Orthofix Srl | 2024 | — |
| +1 | K260146 | Fitbone® Transport and Lengthening System | Orthofix Srl | 2026 | — |
| +1 | K253991 | Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K201567 | Precice® Bone Transport SystemSummary page 4…Primary Predicate and additional predicate device Primary Predicate 510(k) Number Manufacturer Precice® Bone Transport System K201567 NuVasive Specialized Orthopedics Inc. Additional p… | 2020 |
| * | K203399 | Fitbone (R) TaaSummary page 4…Orthopedics Inc. Additional predicate 510(k) Number Manufacturer FITBONE® TAA K203399 Orthofix s.r.l. Reference devices Reference Devices 510(k) Number Manufacture… | 2021 |
| † | K973944 | Orthofix Femoral Nailing Sytem | 1997 |
| † | K961027 | Orthofix Tibial Nailing System | 1996 |
What descends from it? (2)
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)
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 41 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 8 of the 19 ancestors have a recall of any class.
- Of its descendants, K260146 (Orthofix Srl, 2026) has gone furthest, with 0 descendants 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. 2024, 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?
"FITBONE Transport and Lengthening system" is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of the long bones.
The "FITBONE Transport and Lengthening system" is indicated for adult only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232169 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232169: FITBONE® Transport and Lengthening System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232169
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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