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Evonik’s PEEK-based Arthroscopy Implants Earn CE & Indian FDA Certification

Published on 2016-02-12. Author : SpecialChem

ESSEN -- Polyetheretherketone (PEEK) suture anchors and Softfix-PK interference screws manufactured by BIOTEK, an Indian manufacturer of arthroscopy implants, have received the CE mark certificate and Indian FDA approval. All these next generation arthroscopy implants are made from Evonik’s VESTAKEEP ® PEEK.

Evonik
Fig. 1: Evonik

PEEK suture anchors are ideal for soft tissue repair in shoulder, hip, elbow, ankle, wrist & knee arthroscopic procedures. They have tremendous pull-out strength and excellent biocompatibility.
Implant can be manually inserted using the disposable handled Version.

Softfix-PK has a special design and is the first interference screw to feature perforations. Depending on the screw size, the screw body can have 6 to 10 perforations. Reduced Implant mass, increased bone-implant interface, three-dimensional bone ingrowth or faster bone substitution are only some of the advantages of Softfix-PK screw made from the VESTAKEEP® PEEK.

Excellent mechanical properties with VESTAKEEP® PEEK


With Evonik’s cooperation, BIOTEK could add radiolucent and biocompatible PEEK products to its existing range of titanium products. “We have chosen VESTAKEEP® PEEK because it is known for its excellent mechanical properties but also its superior biocompatibility and biostability. With this material we can achieve the expected features of our new generation products” says Rajendra Patel, Managing Director BIOTEK.

Marc Knebel, Director of VESTAKEEP® Medical from Evonik Resource Efficiency GmbH, adds: "Our PEEK has already received CE certificate, and FDA 510 (K) approvals in a broad range of applications, e.g. spinal implants, suture anchors, or cranial implants."

"We are pleased with the approval of PEEK arthroscopy implants which are made of VESTAKEEP®," said Dharmesh Chotalia, Associate Director-Business Development at Evonik India. The excellent sterilization resistance and good combination of stiffness and ductility of VESTAKEEP® PEEK make it suitable for medical implant applications that must meet the extremely high demands/requirements of the medical industry. VESTAKEEP® PEEK provides a modulus of elasticity similar to that of bone.

About Resource Efficiency


The Resource Efficiency segment is led by Evonik Resource Efficiency GmbH and supplies high performance materials for environmentally friendly as well as energy-efficient systems to the automotive, paints & coatings, adhesives, construction, and many other industries. This segment employed about 7,800 employees, and generated sales of around €4 billion in 2014.

About Evonik


Evonik, the creative industrial group from Germany, is one of the world leaders in specialty chemicals, operating in the Nutrition & Care, Resource Efficiency and Performance Materials segments. The company benefits from its innovative prowess and integrated technology platforms. In 2014 more than 33,000 employees generated sales of around €12.9 billion and an operating profit (adjusted EBITDA) of about €1.9 billion.

Source: Evonik

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