Exactech wins FDA nod for Alteon Cup, XLE liner acetabular system

Exactech (NSDQ:EXAC) said today it won FDA 510(k) clearance for its new Alteon Cup and XLE liner acetabular system. The Gainesville, Fla.-based company said that the newly released devices are integrated into its Alteon Platform system. The Alteon Cup will include multiple implant configurations and bearing options and features an asymmetric porous coating. Exactech said that the Alteon Cup is intended for use with the Alteon XLE crosslinked vitamin-E enhanced acetabular linings. “The new Alteon Acetabular component joins modern technology with beautiful design. An optimized fixation surface and head-liner-shell combinations make this socket, and the intent of its design, more versatile and reproducible, and therefore simply more fun to use,” Dr. Jose Rodriguez of the Hospital for Special Surgery said in a prepared statement. The company said that it plans to “aggressively expand” its rollout of the Alteon Cup in the U.S. during the second half of the year, with a full launch later this year. “The clearance of this Cup is an important milestone for the Alteon Platform System. This rounds out an already robust system, taking the Alteon portfolio to the next level,” reconstruction biz unit senior VP Steve Szabo said in a press release. Earlier this week, Exactech said that it acquired knee replacement surgery instrument maker XpandOrtho for an undisclosed amount. The post Exactech wins FDA nod for Alteon Cup, XLE liner acetabular system ap...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Orthopedics Regulatory/Compliance Exactech Inc. Source Type: news