Medical design and manufacturing news

Medical design and manufacturing news

Spinal Element’s FDA clearance for Ti-Bond surface coating technology; Insulet collaborates with Samsung; Evonik’s implant-grade PEEK filament.

November 12, 2018

Spinal Elements' Lucent XP expandable lumbar interbody system
(Photo courtesy Spinal Elements/Business Wire)

Spinal Elements’ FDA clearance of Ti-Bond titanium coating
Carlsbad, California-based Spinal Elements received FDA clearance for claims related to the macro-, micro-, and nano-surface structure of its Ti-Bond surface coating technology. Highlighting Spinal Elements’ portfolio are a number of products featuring Ti-Bond, including the most recently introduced Lucent XP height- and lordosis-expandable interbody device.

Interbody fusion products featuring Ti-Bond technology are comprised of a PEEK body which provides the favorable modulus and imaging characteristics surgeons have come to trust while the multi-structured Ti-Bond-coated surfaces are designed to provide a favorable environment at the vertebral endplate. Since its initial introduction in 2012, products featuring the Ti-Bond surface coating technology have benefitted tens of thousands of patients.


Insulet collaborates with Samsung for Galaxy smartphone-controlled insulin pump delivery system
Insulet Corp. a global leader in tubeless insulin pump technology with its Omnipod Insulin Management System (Omnipod System), is collaborating with Samsung Electronics America Inc. for a Samsung Galaxy smartphone-controlled Omnipod System. Once approved, the system will be the first device providing consumers the ability to use their personal Galaxy smartphone1 to securely control their insulin pump therapy.

The Samsung Knox mobile security platform is built into all Samsung mobile devices and is comprised of overlapping defense and security mechanisms to protect against cybersecurity risks. Insulet’s FDA-cleared Omnipod DASH Insulin Management System (Omnipod DASH System) has been designed as an app on a locked-down mobile phone incorporating state-of-the-art security features. The Knox platform complements the Omnipod DASH System security features by verifying the integrity of the Samsung mobile device through a series of security checks starting from the hardware level and extending through the operating system, creating a highly-secure platform. This will allow users to securely operate their Omnipod System from their smartphone.


Evonik develops first PEEK filament in implant-grade quality for 3D printing
Evonik has become the first company to develop a polymer filament based on PEEK (polyether ether ketone) in implant-grade quality for use as a 3D printing material for implants. This high-performance material can be used in fused filament fabrication (FFF) technology and is expected to enable additive production of three-dimensional plastic parts for medical implants in the human body.

The new PEEK filament is based on VESTAKEEP i4 G, a highly viscous implant-grade material made by Evonik. The product, which exhibits impressive biocompatibility, biostability, and x-ray transparency, is easy to process and has been established for years as a high-performance material in medical technology applications such as spinal implants, sports medicine, and maxillofacial surgery.

© Evnoik |
Evonik’s polymer filament based on PEEK (polyether ether ketone) in implant-grade quality is for use as a 3D printing material.


Testing grade enables cost-effective process adaptation
Evonik will additionally be offering a less expensive “testing grade” version of its PEEK filament for FFF technology. The testing-grade material has the exact same processing and mechanical product properties as the implant-grade material—but without the documentation needed for approval in medical device applications. This offers a cost-effective way of adapting the processing characteristics of the high-performance plastic for printing processes. The natural-colored filament, which has a diameter of 1.75mm, is wound on 500gspools suitable for direct use in standard FFF 3D printers for PEEK materials.

In the Q1 2019, the testing grade will be followed by an implant-grade from VESTAKEEP i4 G, which can be provided with the required extensive approval documentation.