510(k) · Cleared
ClearedEllipse Precice Intramedullary Limb Lengthening System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellipse Technologies, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Oct 19, 2012 as substantially equivalent to K101997 (Ellipse Technologies, Inc., 2011) after a 353-day review. Its family tree reaches back 5 generations to 1983. 15 later devices descend from it.
- Decided
- Oct 19, 2012
- Review
- 353 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K831576 (1983). 6 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 4 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 3 generations backK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
- 2 generations backK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
- 1 generation backK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
- This deviceK113219 Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2012
- Descendant · cites it directly · 14 of its ownK131490 Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- Descendant · 2 generations on · 10 of its ownK163368 Fitbone TaaWittenstein Intens GmbH · 2017
- Descendant · 3 generations on · 9 of its ownK203399 Fitbone (R) TaaWittenstein Intens GmbH · 2021
- Descendant · 4 generations on · 3 of its ownK220234 Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2023
- Descendant · 4 generations on · 2 of its ownK233867 Fitbone TrochantericOrthofix Srl · 2024 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K131490Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014 · cites it directly14descendants
- K163368Fitbone TaaWittenstein Intens GmbH · 2017 · 2 generations on10descendants
- K203399Fitbone (R) TaaWittenstein Intens GmbH · 2021 · 3 generations on9descendants
- K220234Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2023 · 4 generations on3descendants
- K233867Fitbone TrochantericOrthofix Srl · 2024 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −4 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −3 | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthodyne, Inc. | 2001 | 1 |
| −2 | K031219 | Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthofix, Inc. | 2003 | 1 |
| −1 | K101997 | Ellipse Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2011 | 2 |
| 0 (this device) | K113219 | Ellipse Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2012 | — |
| +1 | K131490 | Ellipse Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | — |
| +2 | K163368 | Fitbone Taa | Wittenstein Intens GmbH | 2017 | — |
| +3 | K203399 | Fitbone (R) Taa | Wittenstein Intens GmbH | 2021 | — |
| +4 | K220234 | Precice Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2023 | — |
| +4 | K233867 | Fitbone Trochanteric | Orthofix Srl | 2024 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K101997 | Ellipse Intramedullary Limb Lengthening SystemSummary page 2…ia and femurs. 7. Substantial equivalence Documentation demonstrates substantial equivalence to the Ellipse Intramnedullary Limb Lengthening System cleared under K 10 1997 (cleared on July 12, 2011). The purpose of this premarket notification is to include additional labeling materials for the Home U… | 2011 |
What descends from it? (15)
See all 153 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 29 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K131490 (Ellipse Technologies, Inc., 2014) has gone furthest, with 14 descendants of its own.
- 5 other devices also cite its predicate K101997.
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. 2012, 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 Ellipse Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femurs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113219 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113219: Ellipse Precice Intramedullary Limb 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/K113219
Report an extraction error
Are you the manufacturer?
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