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 Sep 16, 2020 as substantially equivalent to K171376 (MedShape, Inc., 2017) and 1 other predicate after a 208-day review. Its family tree reaches back 5 generations to 1998. 3 later devices descend from it.
- Decided
- Sep 16, 2020
- Review
- 208 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K974781 (1998). 13 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK974781 Depuy Ace Aim (R) Titanium Supracondylar NailDepuy, Inc. · 1998
- 4 generations backK023115 Ace VersanailDePuy Orthopaedics, Inc. · 2002
- 3 generations backK101934 Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail…Medshape Solutions · 2011
- 2 generations backK113828 Dynanail Ankle Arthrodesis NailMedShape, Inc. · 2012
- 1 generation backK171376 DynaNail TTC Fusion SystemMedShape, Inc. · 2017
- This deviceK200430 Precice® Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. · 2020
- Descendant · cites it directly · 1 of its ownK230765 Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK261651 Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026
- Descendant · cites it directly · 0 of its ownK202348 External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020
Most influential descendants
Showing 3 of 3 · See all- K230765Precice Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. · 2023 · 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K974781 | Depuy Ace Aim (R) Titanium Supracondylar Nail | Depuy, Inc. | 1998 | — |
| −4 | K023115 | Ace Versanail | DePuy Orthopaedics, Inc. | 2002 | — |
| −3 | K101934 | Dynnail, 12MM, Locking Screw, 4.6 MM, Deployment Frame, Dynnail, Models… | Medshape Solutions | 2011 | — |
| −2 | K113828 | Dynanail Ankle Arthrodesis Nail | MedShape, Inc. | 2012 | — |
| −1 | K171376 | DynaNail TTC Fusion System | MedShape, Inc. | 2017 | — |
| 0 (this device) | K200430 | Precice® Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | 2020 | — |
| +1 | K230765 | Precice Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | 2023 | — |
| +2 | K261651 | Precice™ Max System and Precice™ Ankle Salvage System | NuVasive Specialized Orthopedics | 2026 | — |
| +1 | 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 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K171376 | DynaNail TTC Fusion SystemSummary page 4…devices: For tibio-talo-calcaneal fusion the Precice Ankle Salvage System is substantially equivalent to the predicate device DynaNail TTC Fusion System (K171376). For fracture fixation, including opened and closed fracture fixation, pseudarthrosis, mal-unions, non-unions, or bon… | 2017 |
| * | K180503 | PRECICE STRYDE SystemSummary page 4…he fusion site, and for subsequent limb lengthening the Precice Ankle Salvage System is substantially equivalent to the predicate device Precice Stryde System (K180503). In addition, the following reference device was used to establish substantial equivalence, Precice System (K173129).… | 2018 |
| † | K173129 | PRECICE System | 2017 |
What descends from it? (3)
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 22 years and passes through 5 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 13 ancestors have a recall of any class.
- Of its descendants, K230765 (Nuvasive Specialized Orthopedics, Inc., 2023) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K171376.
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. 2020, 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 intended for tibio-talo-calcaneal fusions. When used for TTC 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/K200430 · printed Nov 3, 2026
Cite this page
510(k) Report. “K200430: Precice® Ankle Salvage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K200430
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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