Categories: Approval

Arthroscopy implants made from VESTAKEEP ® PEEK are now CE approved

Bengaluru, January 30, 2016: 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.

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. Theexcellent 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.

Corporate Comm India(CCI NewsWire)

The Pharma Times News Bureau

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