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
Nuvasive Specialized Orthopedics, Inc. · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Mar 7, 2017 as substantially equivalent to K160325 (Ellipse Technologies, Inc., 2016) after a 33-day review. Its family tree reaches back 10 generations to 1983. 1 later device descends from it.
- Decided
- Mar 7, 2017
- Review
- 33 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K831576 (1983). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 6 generations between
- 3 generations backK141023 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- 2 generations backK151131 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · Recalled
- 1 generation backK160325 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016
- This deviceK170346 PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK261651 Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026
Show all 10 generations
- Root · 10 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 9 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 8 generations backK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
- 7 generations backK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
- 6 generations backK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
- 5 generations backK131677 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- 4 generations backK133289 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- 3 generations backK141023 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- 2 generations backK151131 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · Recalled
- 1 generation backK160325 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016
- This deviceK170346 PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −9 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −8 | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthodyne, Inc. | 2001 | 1 |
| −7 | K031219 | Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthofix, Inc. | 2003 | 1 |
| −6 | K101997 | Ellipse Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2011 | 2 |
| −5 | K131677 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| −4 | K133289 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| −3 | K141023 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | — |
| −2 | K151131 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Incorporated | 2015 | 2 |
| −1 | K160325 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2016 | — |
| 0 (this device) | K170346 | PRECICE Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2017 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K160325 | PRECICE Intramedullary Limb Lengthening SystemSummary page 4…of the tibia and femur. 7. Substantial equivalence: The subject PRECICE IMLL System is substantially equivalent to the most recently cleared PRECICE IMLL System (K160325). Substantial equivalence is based on indications for use, technological characteristics, and principles of operation.… | 2016 |
| † | K160267 | PRECICE Trauma Nail System | 2016 |
| † | K083497 | Zimmer Natural Nail System Piriformis Fossa and Greater Trochanter Antegrade Femoral Nails | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261651 | Precice™ Max System and Precice™ Ankle Salvage System | 2026 | 0 |
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 34 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 11 ancestors have a recall of any class.
- Of its descendants, K261651 (NuVasive Specialized Orthopedics, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K160325.
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. 2017, 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 imb 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/K170346 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170346: 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/K170346
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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