DePuy Synthes lands FDA clearance for Velys robotic knee system

Image from Depuy Synthes/Johnson & Johnson

Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes announced that it received FDA 510(k) clearance for the Velys system.

Velys is a robotic-assisted system designed for use with the Attune total knee system and its cleared indications for use and it will become part of the broader Velys digital surgery platform of connected technologies, according to a news release.

DePuy Synthes touts the Velys robotic-assisted platform as a first-of-its kind, table-mounted solution with an efficient design capable of integrating into any operating room. The company said it adapts to a surgeon’s workflow, offers control they are used to and heps execute accurate bony cuts.

Additionally, the Velys system offers gap balance data for visualization and joint stability predictions, along with accurate, consistent plan execution supporting the Attune total knee system.

Johnson & Johnson and DePuy Synthes acquire…

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  • January 20, 2021
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UK warns on spinal fixation system from Depuy Synthes

The United Kingdom issued a warning for failure in a spinal fixation system manufactured by Johnson & Johnson (NYSE:JNJ) unit DePuy Synthes.

An alert sent out by the Medicines and Healthcare Products Regulatory Agency highlighted an issue with the cracking of the USS II Polyaxial 3D head rings that may result in the loosening of the spinal fixation system prior to completion of the bone healing.

The batch-related issue does not affect all devices, as Depuy issued a field safety notice on Nov. 13, 2019, to inform users of the potential intra-operative or post-operative cracking of head rings that can lead to the rods loosening, poor spinal mechanics, non-union or malunion, pain or dislocation.

Depuy reported that the majority of implant failures occurred and were identified during the procedure, but can happen post-operatively, so the warning applies to those with the fixation system already implanted, too.

The UK government urged those affecte…

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  • July 10, 2020
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