510(k) · Cleared
Recalled · Class II · 2021Precice® Bone Transport 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 10, 2020 as substantially equivalent to K193016 (Nuvasive Specialized Orthopedics, Inc., 2020) after a 60-day review. Its family tree reaches back 6 generations to 2017. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 10, 2020
- Review
- 60 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 6 generations to K172061 (2017). 3 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK172061 PRECICE UNYTE SystemNuvasive Specialized Orthopedics, Inc. · 2017
- 5 generations backK172628 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017
- 4 generations backK173129 PRECICE SystemNuvasive Specialized Orthopedics, Inc. · 2017
- 3 generations backK180503 PRECICE STRYDE SystemNuvasive Specialized Orthopedics, Inc. · 2018 · Recalled
- 2 generations backK182170 PRECICE® BONE TRANSPORT™ SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
- 1 generation backK193016 PRECICE Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020 · Recalled
- This deviceK201567 Precice® Bone Transport SystemNuvasive Specialized Orthopedics, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK232169 FITBONE® Transport and Lengthening SystemOrthofix Srl · 2024
- Descendant · 2 generations on · 0 of its ownK260146 Fitbone® Transport and Lengthening SystemOrthofix Srl · 2026
- Descendant · 2 generations on · 0 of its ownK253991 Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System…Orthofix Srl · 2026
Most influential descendants
Showing 3 of 3 · See all- K232169FITBONE® Transport and Lengthening SystemOrthofix Srl · 2024 · cites it directly2descendants
- K260146Fitbone® Transport and Lengthening SystemOrthofix Srl · 2026 · 2 generations on0descendants
- K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K172061 | PRECICE UNYTE System | Nuvasive Specialized Orthopedics, Inc. | 2017 | — |
| −5 | K172628 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2017 | — |
| −4 | K173129 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2017 | — |
| −3 | K180503 | PRECICE STRYDE System | Nuvasive Specialized Orthopedics, Inc. | 2018 | 1 |
| −2 | K182170 | PRECICE® BONE TRANSPORT™ System | Nuvasive Specialized Orthopedics, Inc. | 2019 | 1 |
| −1 | K193016 | PRECICE Bone Transport System | Nuvasive Specialized Orthopedics, Inc. | 2020 | 1 |
| 0 (this device) | K201567 | Precice® Bone Transport System | Nuvasive Specialized Orthopedics, Inc. | 2020 | — |
| +1 | K232169 | FITBONE® Transport and Lengthening System | Orthofix Srl | 2024 | — |
| +2 | K260146 | Fitbone® Transport and Lengthening System | Orthofix Srl | 2026 | — |
| +2 | K253991 | Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA | Orthofix Srl | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K193016 | PRECICE Bone Transport SystemSummary page 4…C. Predicate Devices The subject Precice® Bone Transport System is substantially equivalent to the primary predicate device, Precice® Bone Transport System (K193016). D. Device Description The Precice® Bone Transport System includes the Precice ® Bone Transport Nail, locking screws,… | 2020 |
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 |
|---|---|---|---|
| K232169 | FITBONE® Transport and Lengthening System | 2024 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2021 | Class II | Z-1324-2021 | Under Investigation by firm | Due to complaints of adverse events potentially related to biological safety. The complaints included report of pain and bony abnormalities at the interface between the telescoping nail segments. |
| Jul 24, 2020 | Class II | Z-0069-2021 | Device Design | During explantation, standard removal tools can generate sufficient forces to cause distal plug to disassociate from the bone transport system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 1 company; a new generation was cleared every 4 months on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K232169 (Orthofix Srl, 2024) has gone furthest, with 2 descendants of its own.
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® Bone Transport 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/K201567 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201567: Precice® Bone Transport System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201567
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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