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 Apr 4, 2016 as substantially equivalent to K151131 (Ellipse Technologies, Incorporated, 2015) after a 59-day review. Its family tree reaches back 9 generations to 1983. 5 later devices descend from it.
- Decided
- Apr 4, 2016
- Review
- 59 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K831576 (1983). 10 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 5 generations between
- 3 generations backK133289 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- 2 generations backK141023 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- 1 generation backK151131 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · Recalled
- This deviceK160325 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 · cites it directly · 1 of its ownK170346 PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK261651 Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026
- Descendant · 3 generations on · 0 of its ownK202348 External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020
Show all 9 generations
- Root · 9 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 8 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 7 generations backK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
- 6 generations backK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
- 5 generations backK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
- 4 generations backK131677 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- 3 generations backK133289 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- 2 generations backK141023 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- 1 generation backK151131 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · Recalled
- This deviceK160325 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- 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 · cites it directly1descendant
- K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026 · 2 generations on0descendants
- K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −8 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −7 | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthodyne, Inc. | 2001 | 1 |
| −6 | K031219 | Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthofix, Inc. | 2003 | 1 |
| −5 | K101997 | Ellipse Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2011 | 2 |
| −4 | K131677 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| −3 | K133289 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| −2 | K141023 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | — |
| −1 | K151131 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Incorporated | 2015 | 2 |
| 0 (this device) | 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 | — |
| +1 | K170346 | PRECICE Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2017 | — |
| +2 | K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics | 2026 | — |
| +3 | K202348 | External Remote Controller ERC 4P | Nuvasive Specialized Orthopedics, Inc. | 2020 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K151131 | PRECICE Intramedullary Limb Lengthening SystemSummary page 4…ry Limb Lengthening System is substantially equivalent to the following 510(k) cleared device: Ellipse PRECICE Intramedullary Limb Lengthening System (K151131) Page 1 of 2… | 2015 |
| † | K143355 | The Simple Locking IntraMedullary (SLIM) System | 2015 |
What descends from it? (5)
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)
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 33 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 10 ancestors have a recall of any class.
- Of its descendants, K170169 (Nuvasive Specialized Orthopedics, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K151131.
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. 2016, 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 PRECICE Intramedullary Limb Lengthening System is indicated for limb lengthening of the tibia and femur.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160325 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160325: 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/K160325
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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