510(k) · Cleared
ClearedFitbone (R) Taa
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wittenstein Intens GmbH · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Feb 17, 2021 as substantially equivalent to K163368 (Wittenstein Intens GmbH, 2017) and 2 other predicates after a 90-day review. Its family tree reaches back 8 generations to 1983. 9 later devices descend from it.
- Decided
- Feb 17, 2021
- Review
- 90 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K831576 (1983). 11 ancestors in all. 9 later devices descend from it, 4 citing it directly.
- Root · 8 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 7 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 6 generations backK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
- 5 generations backK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
- 4 generations backK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
- 3 generations backK113219 Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2012
- 2 generations backK131490 Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- 1 generation backK163368 Fitbone TaaWittenstein Intens GmbH · 2017
- This deviceK203399 Fitbone (R) TaaWittenstein Intens GmbH · 2021
- Descendant · cites it directly · 3 of its ownK220234 Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK233867 Fitbone TrochantericOrthofix Srl · 2024 · Recalled
- Descendant · cites it directly · 2 of its ownK232169 FITBONE® Transport and Lengthening SystemOrthofix Srl · 2024
- Descendant · 2 generations on · 1 of its ownK232267 Precice Max SystemNuvasive Specialized Orthopedics, Incorporated · 2023 · Recalled
- Descendant · 2 generations on · 1 of its ownK230765 Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. · 2023
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K220234Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2023 · cites it directly3descendants
- K233867Fitbone TrochantericOrthofix Srl · 2024 · cites it directly2descendants
- K232169FITBONE® Transport and Lengthening SystemOrthofix Srl · 2024 · cites it directly2descendants
- K232267Precice Max SystemNuvasive Specialized Orthopedics, Incorporated · 2023 · 2 generations on1descendant
- K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. · 2023 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −7 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −6 | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthodyne, Inc. | 2001 | 1 |
| −5 | K031219 | Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthofix, Inc. | 2003 | 1 |
| −4 | K101997 | Ellipse Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2011 | 2 |
| −3 | K113219 | Ellipse Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2012 | — |
| −2 | K131490 | Ellipse Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | — |
| −1 | K163368 | Fitbone Taa | Wittenstein Intens GmbH | 2017 | — |
| 0 (this device) | K203399 | Fitbone (R) Taa | Wittenstein Intens GmbH | 2021 | — |
| +1 | K220234 | Precice Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2023 | — |
| +1 | K233867 | Fitbone Trochanteric | Orthofix Srl | 2024 | 1 |
| +1 | K232169 | FITBONE® Transport and Lengthening System | Orthofix Srl | 2024 | — |
| +2 | K232267 | Precice Max System | Nuvasive Specialized Orthopedics, Incorporated | 2023 | 1 |
| +2 | K230765 | Precice Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2013 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K163368 | Fitbone TaaSummary page 4…Orthopedic Predicate devices and reference devices Primary Predicate 510(k) Number Manufacturer FITBONE® TAA K163368 WITTENSTEIN intens GmbH Additional Predicate PRECICE® Intramedullary Limb K133289 - Ellipse Te… | 2017 |
| * | K133289 | Precice Intramedullary Limb Lengthening SystemSummary page 4…) Number Manufacturer FITBONE® TAA K163368 WITTENSTEIN intens GmbH Additional Predicate PRECICE® Intramedullary Limb K133289 - Ellipse Technologies (now: Lengthening System K131677 NuVasive Speci… | 2013 |
| * | K131677 | Precice Intramedullary Limb Lengthening SystemSummary page 4…TENSTEIN intens GmbH Additional Predicate PRECICE® Intramedullary Limb K133289 - Ellipse Technologies (now: Lengthening System K131677 NuVasive Specialized Orthopedics Inc.) Refere… | 2013 |
| † | K020885 | Fassire-Duval Telescopic IM System | 2003 |
| † | K192181 | PRECICE Plating System | 2019 |
What descends from it? (9)
4 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 38 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 4 of the 11 ancestors have a recall of any class.
- Of its descendants, K220234 (Nuvasive Specialized Orthopedics, Inc., 2023) has gone furthest, with 3 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. 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 WITTENSTEIN intens GmbH FITBONE® TAA intramedullary lengthening system is intended 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203399 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203399: Fitbone (R) Taa.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203399
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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