510(k) · Cleared
ClearedFitboneTM Trochanteric
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 Apr 10, 2025 as substantially equivalent to K233867 (Orthofix Srl, 2024) after an 84-day review. Its family tree reaches back 10 generations to 1983.
- Decided
- Apr 10, 2025
- Review
- 84 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K831576 (1983). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 6 generations between
- 3 generations backK163368 Fitbone TaaWittenstein Intens GmbH · 2017
- 2 generations backK203399 Fitbone (R) TaaWittenstein Intens GmbH · 2021
- 1 generation backK233867 Fitbone TrochantericOrthofix Srl · 2024 · Recalled
- This deviceK250112 FitboneTM TrochantericOrthofix Srl · 2025
Show all 10 generations
- Root · 10 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 9 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 8 generations backK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
- 7 generations backK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
- 6 generations backK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
- 5 generations backK113219 Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2012
- 4 generations backK131490 Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- 3 generations backK163368 Fitbone TaaWittenstein Intens GmbH · 2017
- 2 generations backK203399 Fitbone (R) TaaWittenstein Intens GmbH · 2021
- 1 generation backK233867 Fitbone TrochantericOrthofix Srl · 2024 · Recalled
- This deviceK250112 FitboneTM TrochantericOrthofix Srl · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −9 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −8 | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthodyne, Inc. | 2001 | 1 |
| −7 | K031219 | Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthofix, Inc. | 2003 | 1 |
| −6 | K101997 | Ellipse Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2011 | 2 |
| −5 | K113219 | Ellipse Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2012 | — |
| −4 | K131490 | Ellipse Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | — |
| −3 | K163368 | Fitbone Taa | Wittenstein Intens GmbH | 2017 | — |
| −2 | K203399 | Fitbone (R) Taa | Wittenstein Intens GmbH | 2021 | — |
| −1 | K233867 | Fitbone Trochanteric | Orthofix Srl | 2024 | 1 |
| 0 (this device) | K250112 | FitboneTM Trochanteric | Orthofix Srl | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K233867 | Fitbone TrochantericSummary page 5…y predicate and additional reference devices Primary Predicate 510(k) Number Manufacturer FitboneTM Trochanteric K233867 Orthofix s.r.l. Reference Devices 510(k) Number Manufacturer FITBONE® TAA… | 2024 |
| † | K203399 | Fitbone (R) Taa | 2021 |
| † | K220234 | Precice Intramedullary Limb Lengthening System | 2023 |
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 42 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 5 of the 13 ancestors have a recall of any class.
- 1 other device also cites its predicate K233867.
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. 2025, 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?
FitboneTM Trochanteric is indicated for limb lengthening of the femur.
FitboneTM Trochanteric is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.
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/K250112 · printed Nov 4, 2026
Cite this page
510(k) Report. “K250112: FitboneTM Trochanteric.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K250112
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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