510(k) · Cleared
ClearedPrecice™ Max System and Precice™ Ankle Salvage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
NuVasive Specialized Orthopedics · HSB Rod, Fixation, Intramedullary And Accessories
Cleared on Jun 18, 2026 as substantially equivalent to K170346 (Nuvasive Specialized Orthopedics, Inc., 2017) and 3 other predicates after a 30-day review. Its family tree reaches back 11 generations to 1983.
- Decided
- Jun 18, 2026
- Review
- 30 days
- Class
- Class II
- Product code
- HSB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 11 generations to K831576 (1983). 33 ancestors in all. No later device cites it as a predicate yet.
- Root · 11 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 7 generations between
- 3 generations backK151131 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · Recalled
- 2 generations backK160325 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016
- 1 generation backK170346 PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017
- This deviceK261651 Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026
Show all 11 generations
- Root · 11 generations backK831576 OrthofixElectro-Biology, Inc. · 1983
- 10 generations backK955848 Orthofix ModulsystemOrthofix, Inc. · 1996 · Recalled
- 9 generations backK010322 Iskd (Intramedullary Skeletal Kinetic Distractor)Orthodyne, Inc. · 2001 · Recalled
- 8 generations backK031219 Modification to Iskd (Intramedullary Skeletal Kinetic Distractor)Orthofix, Inc. · 2003 · Recalled
- 7 generations backK101997 Ellipse Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2011 · Recalled
- 6 generations backK131677 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- 5 generations backK133289 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2013
- 4 generations backK141023 Precice Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2014
- 3 generations backK151131 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Incorporated · 2015 · Recalled
- 2 generations backK160325 PRECICE Intramedullary Limb Lengthening SystemEllipse Technologies, Inc. · 2016
- 1 generation backK170346 PRECICE Intramedullary Limb Lengthening SystemNuvasive Specialized Orthopedics, Inc. · 2017
- This deviceK261651 Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K831576 | Orthofix | Electro-Biology, Inc. | 1983 | — |
| −10 | K955848 | Orthofix Modulsystem | Orthofix, Inc. | 1996 | 23 |
| −9 | K010322 | Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthodyne, Inc. | 2001 | 1 |
| −8 | K031219 | Modification to Iskd (Intramedullary Skeletal Kinetic Distractor) | Orthofix, Inc. | 2003 | 1 |
| −7 | K101997 | Ellipse Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2011 | 2 |
| −6 | K131677 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| −5 | K133289 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2013 | — |
| −4 | K141023 | Precice Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2014 | — |
| −3 | K151131 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Incorporated | 2015 | 2 |
| −2 | K160325 | PRECICE Intramedullary Limb Lengthening System | Ellipse Technologies, Inc. | 2016 | — |
| −1 | K170346 | PRECICE Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2017 | — |
| 0 (this device) | 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 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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? (4)
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 |
|---|---|---|---|
| * | K170346 | PRECICE Intramedullary Limb Lengthening SystemSummary page 5…Code: HSB, HWC Regulatory Class: II, Panel Code: 87 Primary Predicate: Precice™ Intramedullary Limb Lengthening System (K170346) Additional Predicates: Precice™ Max System (K232267) Precice™ Ankle Salvage System (K230765)… | 2017 |
| * | K232267 | Precice Max SystemSummary page 5…l Code: 87 Primary Predicate: Precice™ Intramedullary Limb Lengthening System (K170346) Additional Predicates: Precice™ Max System (K232267) Precice™ Ankle Salvage System (K230765) Precice™ Intramedullary Limb Lengthening System… | 2023 |
| * | K230765 | Precice Ankle Salvage SystemSummary page 5…ry Limb Lengthening System (K170346) Additional Predicates: Precice™ Max System (K232267) Precice™ Ankle Salvage System (K230765) Precice™ Intramedullary Limb Lengthening System (K220234) Purpose: The purpose of this… | 2023 |
| * | K220234 | Precice Intramedullary Limb Lengthening SystemSummary page 5…Max System (K232267) Precice™ Ankle Salvage System (K230765) Precice™ Intramedullary Limb Lengthening System (K220234) Purpose: The purpose of this submission is to request clearance for non-sterile locking screws and end caps, that were previous… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 43 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 8 of the 33 ancestors have a recall of any class.
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. 2026, 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?
Precice™ Max System The Precice™ Max System is indicated for limb lengthening, open and closed fracture fixation, pseudarthrosis, malunions, nonunions, 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). Precice™ Ankle Salvage System The Precice™ Ankle Salvage System is indicated for tibio-talo-calcaneal fusions in adults. When used…
Read the full statement (115 words)
Precice™ Max System
The Precice™ Max System is indicated for limb lengthening, open and closed fracture fixation, pseudarthrosis, malunions, nonunions, 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).
Precice™ Ankle Salvage System
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K261651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261651: Precice™ Max System and 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/K261651
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026