Precice Intramedullary Limb Lengthening System (K220234)
Description
Precice Intramedullary Limb Lengthening System by Nuvasive Specialized Orthopedics, Inc., an FDA 510(k) cleared orthopedic device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K220234
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Precice Intramedullary Limb Lengthening System (K220234) cites 6 predicate devices and is itself cited by 4 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K203399 | FITBONE(R) TAA | Wittenstein Intens GmbH | 2021 |
| K191336 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2019 |
| K172628 | PRECICE System | Nuvasive Specialized Orthopedics, Inc. | 2017 |
| K170169 | PRECICE Intramedullary Limb Lengthening System | Nuvasive Specialized Orthopedics, Inc. | 2017 |
| K131490 | ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | Ellipse Technologies, Inc. | 2014 |
| K113219 | ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | Ellipse Technologies, Inc. | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K250112 | FitboneTM Trochanteric | Orthofix Srl | 2025 |
| K233867 | Fitbone Trochanteric | Orthofix Srl | 2024 |
| K232267 | Precice Max System | Nuvasive Specialized Orthopedics, I... | 2023 |
| K230765 | Precice Ankle Salvage System | Nuvasive Specialized Orthopedics, Inc. | 2023 |
Trace the full predicate network for K220234
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.