510(k) · Cleared
Recalled · Class II · 2021Ellipse 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 Jul 12, 2011 as substantially equivalent to K010322 (Orthodyne, Inc., 2001) and 1 other predicate after a 362-day review. Its family tree reaches back 4 generations to 1983. 29 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 12, 2011
- Review
- 362 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K831576 (1983). 5 ancestors in all. 29 later devices descend from it, 6 citing it directly.
- Root · 4 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 3 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 2 generations backK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
- 1 generation backK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
- This deviceK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011
- Descendant · cites it directly · 21 of its ownK131677 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- Descendant · 2 generations on · 19 of its ownK133289 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- Descendant · cites it directly · 15 of its ownK113219 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
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K131677Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013 · cites it directly21descendants
- K133289Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013 · 2 generations on19descendants
- K113219Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2012 · cites it directly15descendants
- K131490Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014 · cites it directly14descendants
- K163368Fitbone TaaWittenstein Intens GmbH · 2017 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −3 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −2 | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthodyne, Inc. | 2001 | 1 |
| −1 | K031219 | Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthofix, Inc. | 2003 | 1 |
| 0 (this device) | K101997 | Ellipse Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2011 | — |
| +1 | K131677 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| +2 | K133289 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 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? (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 |
|---|---|---|---|
| * | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | 2001 |
| * | K031219 | Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Summary page 2…the predicate device demonstrates that the Ellipse Intramedullary Limb Lengthening System is substantially equivalent to the Orthodyne/Orthofix ISKD device (KO 10322 and K03 1219). Substantial equivalence is based on similar indications for use, designs, and on in vitro testing performied. The Ellipse IML… | 2003 |
What descends from it? (29)
See all 296 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131677 | Precice Intramedullary Limb Lengthening System | 2013 | 21 |
| K113219 | Ellipse Precice Intramedullary Limb Lengthening System | 2012 | 15 |
| K131490 | Ellipse Precice Intramedullary Limb Lengthening System | 2014 | 14 |
| K113695 | Ellipse Precice Trauma Nail System | 2012 | 3 |
| K170169 | PRECICE Intramedullary Limb Lengthening System | 2017 | 2 |
| K163653 | NOVOS-NAIL Limb Lengthening System (LLS) | 2017 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 29, 2021 | Class II | Z-0319-2022 | Device Design | The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing treatment, and (3) That no… |
| Feb 12, 2021 | Class II | Z-1349-2021 | Device Design | Due to not having the full complement of biological assessments for all potential patients and as a result the devices are not indicated for use in individuals under the age of 18 years old. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 8.1 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K131677 (Ellipse Technologies, Inc., 2013) has gone furthest, with 21 descendants of its own.
- 3 other devices also cite its predicate K010322.
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. 2011, 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/K101997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101997: Ellipse 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/K101997
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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