510(k) · Cleared
Recalled · Class II · 2021Ellipse Precice Trauma Nail 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 Mar 28, 2012 as substantially equivalent to K101997 (Ellipse Technologies, Inc., 2011) and 2 other predicates after a 103-day review. Its family tree reaches back 5 generations to 1983. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 28, 2012
- Review
- 103 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 5 generations to K831576 (1983). 17 ancestors in all. 3 later devices descend from it, 1 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 deviceK113695 Ellipse Precice Trauma Nail SystemEllipse Technologies, Inc. · 2012
- Descendant · cites it directly · 2 of its ownK141447 Precice Trauma Nail SystemEllipse Technologies, Inc. · 2014
- Descendant · 2 generations on · 1 of its ownK142599 PRECISE Trauma Nail SystemEllipse Technologies, Incorporated · 2015
- Descendant · 3 generations on · 0 of its ownK152370 PRECICE Trauma Nail SystemEllipse Technologies, Incorporated · 2015
Most influential descendants
Showing 3 of 3 · See all- K141447Precice Trauma Nail SystemEllipse Technologies, Inc. · 2014 · cites it directly2descendants
- K142599PRECISE Trauma Nail SystemEllipse Technologies, Incorporated · 2015 · 2 generations on1descendant
- K152370PRECICE Trauma Nail SystemEllipse Technologies, Incorporated · 2015 · 3 generations on0descendants
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) | K113695 | Ellipse Precice Trauma Nail System | Ellipse Technologies, Inc. | 2012 | — |
| +1 | K141447 | Precice Trauma Nail System | Ellipse Technologies, Inc. | 2014 | — |
| +2 | K142599 | PRECISE Trauma Nail System | Ellipse Technologies, Incorporated | 2015 | — |
| +3 | K152370 | PRECICE Trauma Nail System | Ellipse Technologies, Incorporated | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 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 |
|---|---|---|---|
| * | K101997 | Ellipse Intramedullary Limb Lengthening SystemSummary page 2…Substantial equivalence Documentation demonstrates substantial equivalence to the following devices: * Ellipse PRECICE Intramedullary Limb Lengthening System (K101997) * Synthes Distraction Osteogenesis Ring System (K092 190) * Smith and Nephew Trigen Meta-Nail - Femoral and Tibial (… | 2011 |
| * | K092190 | Synthes Distraction Osteogenesis System, MR Conditional with Expanded IndicationsSummary page 2…tial equivalence to the following devices: * Ellipse PRECICE Intramedullary Limb Lengthening System (K101997) * Synthes Distraction Osteogenesis Ring System (K092 190) * Smith and Nephew Trigen Meta-Nail - Femoral and Tibial (K06l019) The purpose of this premarket notification is to provi… | 2010 |
| * | K061019 | Trigen Meta-Nail Retrograde Femoral and Tibial Nails | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141447 | Precice Trauma Nail System | 2014 | 2 |
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-1350-2021 | 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 29 years and passes through 4 companies; a new generation was cleared every 5.1 years on median.
- 10 of the 17 ancestors have a recall of any class.
- Of its descendants, K141447 (Ellipse Technologies, Inc., 2014) has gone furthest, with 2 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. 2012, 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 Trauma Nail System is indicated for closed fracture fixation, pseudoarthrosis, or mal-unions and non-unions of long bones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113695: Ellipse Precice Trauma Nail System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113695
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