MHRA Device Safety Information – MDSI2306
Published on 12 April 2023
From: NHSScotland Assure
MDSI2306 - NuVasive Specialized Orthopedics (NSO) PRECICE Titanium Systems: UK Suspension Lifted
Documents
Details
The MHRA has conducted a thorough assessment of technical and biological safety information provided by NSO and is satisfied that the PRECICE Titanium subset of devices (Intra-Medullary Limb Lengthening (IMLL), Short, Unyte and Freedom) can now be used in adults in the UK. NSO has agreed to meet a set of conditions to effectively monitor the long-term biological safety of the devices.
Please note: the CE marks for PRECICE Biodur systems (Bone Transport, Stryde and Plate) have NOT been reinstated and these devices remain suspended from the UK market.