510(k) · Cleared
ClearedFitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
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 May 8, 2026 as substantially equivalent to K233867 (Orthofix Srl, 2024) and 2 other predicates after a 147-day review. Its family tree reaches back 10 generations to 1983.
- Decided
- May 8, 2026
- Review
- 147 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K831576 (1983). 21 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 backK232169 FITBONE® Transport and Lengthening SystemOrthofix Srl · 2024
- This deviceK253991 Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System…Orthofix Srl · 2026
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 backK232169 FITBONE® Transport and Lengthening SystemOrthofix Srl · 2024
- This deviceK253991 Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System…Orthofix Srl · 2026
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 | K232169 | FITBONE® Transport and Lengthening System | Orthofix Srl | 2024 | — |
| 0 (this device) | 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 |
| 2024 | 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? (3)
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…c Predicate devices and additional predicate device Primary Predicate 510(k) Number Manufacturer Fitbone™ Trochanteric K233867 Orthofix s.r.l. Additional Predicates 510(k) Number Manufacturer FITBONE® TAA… | 2024 |
| * | K203399 | Fitbone (R) TaaSummary page 5…eric K233867 Orthofix s.r.l. Additional Predicates 510(k) Number Manufacturer FITBONE® TAA K203399 Orthofix s.r.l. Fitbone Transport and Lengthening K232169 Orthofix s.r.l. System Devic… | 2021 |
| * | K232169 | FITBONE® Transport and Lengthening SystemSummary page 5…ates 510(k) Number Manufacturer FITBONE® TAA K203399 Orthofix s.r.l. Fitbone Transport and Lengthening K232169 Orthofix s.r.l. System Device description The subject Implantable bone screws are a line extension o… | 2024 |
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 43 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 9 of the 21 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. 2026, 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™ Trochanteric is indicated for limb lengthening of the femur.Fitbone Trochanteric is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.
FITBONE® TAA is an intramedullary lengthening system for limb lengthening of the femur and tibia. The FITBONE®TAA intramedullary lengthening system is indicated for adult and pediatric (greater than 12 through 21 years of age) patients.
The 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K253991 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253991: Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253991
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026