510(k) · Cleared
ClearedPrecice 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 11, 2013 as substantially equivalent to K101997 (Ellipse Technologies, Inc., 2011) after a 123-day review. Its family tree reaches back 5 generations to 1983. 21 later devices descend from it.
- Decided
- Oct 11, 2013
- Review
- 123 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. 21 later devices descend from it, 6 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 deviceK131677 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- Descendant · cites it directly · 19 of its ownK133289 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- Descendant · cites it directly · 10 of its ownK163368 Fitbone TaaWittenstein Intens GmbH · 2017
- Descendant · cites it directly · 9 of its ownK203399 Fitbone (R) TaaWittenstein Intens GmbH · 2021
- Descendant · cites it directly · 9 of its ownK141023 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK151131 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · Recalled
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K133289Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013 · cites it directly19descendants
- K163368Fitbone TaaWittenstein Intens GmbH · 2017 · cites it directly10descendants
- K203399Fitbone (R) TaaWittenstein Intens GmbH · 2021 · cites it directly9descendants
- K141023Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014 · cites it directly9descendants
- K151131PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · cites it directly6descendants
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) | K131677 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| +1 | K133289 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| +1 | K163368 | Fitbone Taa | Wittenstein Intens GmbH | 2017 | — |
| +1 | K203399 | Fitbone (R) Taa | Wittenstein Intens GmbH | 2021 | — |
| +1 | K141023 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | — |
| +1 | K151131 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Incorporated | 2015 | 2 |
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 |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 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 1…demonstrates that the Ellipse PRECICE System is substantially equivalent to the following 510(k) cleared device: 0Ellipse Intramedullary Limb Lengthening System (K101997) Substantial equivalence is based on similar indications for use, designs, and on in vitrotesting performed.… | 2011 |
What descends from it? (21)
See all 216 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133289 | Precice Intramedullary Limb Lengthening System | 2013 | 19 |
| K163368 | Fitbone Taa | 2017 | 10 |
| K203399 | Fitbone (R) Taa | 2021 | 9 |
| K141023 | Precice Intramedullary Limb Lengthening System | 2014 | 9 |
| K151131 | PRECICE Intramedullary Limb Lengthening System | 2015 | 6 |
| K150656 | PRECICE Intramedullary Limb Lengthening System | 2015 | 3 |
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 30 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, K133289 (Ellipse Technologies, Inc., 2013) has gone furthest, with 19 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. 2013, 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 PRECICE System is indicated for limb lengthening of the tibia and femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131677 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131677: 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/K131677
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