510(k) · Cleared
Recalled · Class II · 2021PRECICE Intramedullary Limb Lengthening System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ellipse Technologies, Incorporated · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 19, 2015 as substantially equivalent to K141023 (Ellipse Technologies, Inc., 2014) and 2 other predicates after a 52-day review. Its family tree reaches back 8 generations to 1983. 6 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 19, 2015
- Review
- 52 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 8 generations to K831576 (1983). 9 ancestors in all. 6 later devices descend from it, 2 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 backK131677 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- 2 generations backK133289 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- 1 generation backK141023 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- This deviceK151131 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015
- Descendant · cites it directly · 5 of its ownK160325 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016
- Descendant · cites it directly · 2 of its ownK170169 PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK191336 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2019
- Descendant · 2 generations on · 1 of its ownK170346 PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017
- Descendant · 3 generations on · 0 of its ownK261651 Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K160325PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016 · cites it directly5descendants
- K170169PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017 · cites it directly2descendants
- K191336PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 2 generations on1descendant
- K170346PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017 · 2 generations on1descendant
- K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026 · 3 generations on0descendants
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 | K131677 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| −2 | K133289 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| −1 | K141023 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | — |
| 0 (this device) | K151131 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Incorporated | 2015 | — |
| +1 | K160325 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2016 | — |
| +1 | K170169 | PRECICE Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2017 | — |
| +2 | K191336 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2019 | — |
| +2 | K170346 | PRECICE Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2017 | — |
| +3 | K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics | 2026 | — |
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 |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K141023 | Precice Intramedullary Limb Lengthening SystemSummary page 5…ollowing 510(k) cleared device: Trade Name: Ellipse PRECICE System Common Name: Intramedullary Nail 510(k) Clearance Number: K141023, K133289, K131677 Substantial equivalence is based on identical indications for use, technological characteristics and… | 2014 |
| * | K133289 | Precice Intramedullary Limb Lengthening SystemSummary page 5…510(k) cleared device: Trade Name: Ellipse PRECICE System Common Name: Intramedullary Nail 510(k) Clearance Number: K141023, K133289, K131677 Substantial equivalence is based on identical indications for use, technological characteristics and in vi… | 2013 |
| * | K131677 | Precice Intramedullary Limb Lengthening SystemSummary page 5…eared device: Trade Name: Ellipse PRECICE System Common Name: Intramedullary Nail 510(k) Clearance Number: K141023, K133289, K131677 Substantial equivalence is based on identical indications for use, technological characteristics and in vitro testi… | 2013 |
What descends from it? (6)
2 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)
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 32 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K160325 (Ellipse Technologies, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K141023.
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. 2015, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151131 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151131: 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/K151131
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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