510(k) · Cleared
ClearedPRECICE 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 Dec 1, 2017 as substantially equivalent to K172628 (Nuvasive Specialized Orthopedics, Inc., 2017) after a 63-day review. Its family tree reaches back 2 generations to 2017. 13 later devices descend from it.
- Decided
- Dec 1, 2017
- Review
- 63 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K172061 (2017). 13 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK172061 PRECICE UNYTE SystemNuvasive Specialized Orthopedics, Inc. · 2017
- 1 generation backK172628 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017
- This deviceK173129 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017
- Descendant · cites it directly · 12 of its ownK180503 PRECICE STRYDE SystemNuvasive Specialized Orthopedics, Inc. · 2018 · Recalled
- Descendant · cites it directly · 6 of its ownK182170 PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
- Descendant · 2 generations on · 4 of its ownK193016 PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · Recalled
- Descendant · 2 generations on · 3 of its ownK200430 Precice® Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. · 2020
- Descendant · 3 generations on · 3 of its ownK201567 Precice® Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · Recalled
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K180503PRECICE STRYDE SystemNuvasive Specialized Orthopedics, Inc. · 2018 · cites it directly12descendants
- K182170PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc. · 2019 · cites it directly6descendants
- K193016PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · 2 generations on4descendants
- K200430Precice® Ankle Salvage SystemNuvasive Specialized Orthopedics, Inc. · 2020 · 2 generations on3descendants
- K201567Precice® Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K172061 | PRECICE UNYTE System | Nuvasive Specialized Orthopedics, Inc. | 2017 | — |
| −1 | K172628 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2017 | — |
| 0 (this device) | K173129 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2017 | — |
| +1 | K180503 | PRECICE STRYDE System | Nuvasive Specialized Orthopedics, Inc. | 2018 | 1 |
| +1 | K182170 | PRECICE® BONE TRANSPORT™ System | Nuvasive Specialized Orthopedics, Inc. | 2019 | 1 |
| +2 | K193016 | PRECICE Bone Transport System | Nuvasive Specialized Orthopedics, Inc. | 2020 | 1 |
| +2 | K200430 | Precice® Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | 2020 | — |
| +3 | K201567 | Precice® Bone Transport System | Nuvasive Specialized Orthopedics, Inc. | 2020 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K172628 | PRECICE SystemSummary page 4…bone transport of long bones. 7. Substantial Equivalence: The subject PRECICE System is substantially equivalent to the most recently cleared PRECICE System (K172628). Substantial equivalence is based on Page 1 of… | 2017 |
| † | K003496 | Cannulated Screw System | 2001 |
What descends from it? (13)
See all 133 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 0 years and passes through 1 company; a new generation was cleared every 2 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K180503 (Nuvasive Specialized Orthopedics, Inc., 2018) has gone furthest, with 12 descendants of its own.
- 2 other devices also cite its predicate K172628.
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 System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173129 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173129: PRECICE System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173129
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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