510(k) · Cleared
ClearedPrecice Ankle Salvage 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 Aug 29, 2023 as substantially equivalent to K200430 (Nuvasive Specialized Orthopedics, Inc., 2020) and 1 other predicate after a 162-day review. Its family tree reaches back 10 generations to 1983. 1 later device descends from it.
- Decided
- Aug 29, 2023
- Review
- 162 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K831576 (1983). 27 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 backK163368 Fitbone TaaWittenstein Intens GmbH · 2017
- 2 generations backK203399 Fitbone (R) TaaWittenstein Intens GmbH · 2021
- 1 generation backK220234 Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2023
- This deviceK230765 Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. · 2023
- 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 backK113219 Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2012
- 4 generations backK131490 Ellipse Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- 3 generations backK163368 Fitbone TaaWittenstein Intens GmbH · 2017
- 2 generations backK203399 Fitbone (R) TaaWittenstein Intens GmbH · 2021
- 1 generation backK220234 Precice Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2023
- This deviceK230765 Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. · 2023
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 | K113219 | Ellipse Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2012 | — |
| −4 | K131490 | Ellipse Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | — |
| −3 | K163368 | Fitbone Taa | Wittenstein Intens GmbH | 2017 | — |
| −2 | K203399 | Fitbone (R) Taa | Wittenstein Intens GmbH | 2021 | — |
| −1 | K220234 | Precice Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2023 | — |
| 0 (this device) | K230765 | Precice Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | 2023 | — |
| +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 | 4 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2020 | 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? (2)
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 |
|---|---|---|---|
| * | K200430 | Precice® Ankle Salvage SystemSummary page 4…HWC C. Predicate Devices The subject Precice Ankle Salvage System is substantially equivalent to the primary predicate device Precice Ankle Salvage System (K200430). The Precice Intramedullary Limb Lengthening System (K220234) served as an additional predicate. D. Device Description… | 2020 |
| * | K220234 | Precice Intramedullary Limb Lengthening SystemSummary page 4…System is substantially equivalent to the primary predicate device Precice Ankle Salvage System (K200430). The Precice Intramedullary Limb Lengthening System (K220234) served as an additional predicate. D. Device Description The Precice Ankle Salvage System is a tibio-talo-calcaneal fusi… | 2023 |
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 40 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 6 of the 27 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 K200430.
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. 2023, 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 Ankle Salvage System is indicated for tibio-talo-calcaneal fusions in adults. When used for tibio-talo-calcaneal fusion, the Precice Ankle Salvage System may be used for open and closed fracture fixation, pseudarthrosis, mal-unions, non-unions, or bone transport of long bones adjacent to the fusion site. The device may be used for subsequent limb lengthening once tibio-talo-calcaneal fusion has been achieved.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230765 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230765: Precice Ankle Salvage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230765
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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