510(k) · Cleared
Recalled · Class II · 2024Precice Max System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nuvasive Specialized Orthopedics, Incorporated · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Dec 15, 2023 as substantially equivalent to K220234 (Nuvasive Specialized Orthopedics, Inc., 2023) after a 137-day review. Its family tree reaches back 10 generations to 1983. 1 later device descends from it. It has been recalled once.
- Decided
- Dec 15, 2023
- Review
- 137 days
- Class
- Class II
- Product code
- HSB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 10 generations to K831576 (1983). 15 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 deviceK232267 Precice Max SystemNuvasive Specialized Orthopedics, Incorporated · 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 deviceK232267 Precice Max SystemNuvasive Specialized Orthopedics, Incorporated · 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) | K232267 | Precice Max System | Nuvasive Specialized Orthopedics, Incorporated | 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 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 2 | 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? (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 |
|---|---|---|---|
| * | K220234 | Precice Intramedullary Limb Lengthening SystemSummary page 4…HSB, HWC C. Predicate Devices The subject Precice Max System is substantially equivalent to the Precice Intramedullary Limb Lengthening System (K220234). Primary Predicate Product Name 510(k) Number Date of Clearance Precice I… | 2023 |
| † | K200430 | Precice® Ankle Salvage System | 2020 |
| † | K193617 | Precice® Screws | 2020 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2024 | Class II | Z-0500-2025 | Under Investigation by firm | Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 7 companies; a new generation was cleared every 3.0 years on median.
- 4 of the 15 ancestors have a recall of any class.
- Of its descendants, K261651 (NuVasive Specialized Orthopedics, 2026) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K220234.
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 Max System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, mal-unions, non-unions, or bone transport of long bones in patients age 18 years and older and indicated for limb lengthening of the femur and tibia in pediatric patients (greater than 12 years old).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232267 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232267: Precice Max System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232267
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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