Zimmer Biomet wins 510(k) for Unite3D

Zimmer Biomet (NYSE:ZBH) said yesterday it won FDA 510(k) clearance for its Unite3D bridge fixation system designed for foot and ankle joint fusion surgery, as an alternative to traditional plates, screws and staples.

The Warsaw, Ind.-based company said the Unite3D system is manufactured using 3D-printing technology, and features proprietary OsseoTi porous metal technology that mimics cancellous bone.

“The Unite3D Bridge Fixation System is unlike anything in our portfolio, and we are proud to commercialize a true innovation in this exciting clinical area. This powerful combination of 3D printing technology and our OsseoTi porous metal material is only the latest contribution from Zimmer Biomet’s robust innovation pipeline. We aim to serve the unique needs of patients and surgeons while expanding our presence in every category of musculoskeletal healthcare, including the rapidly growing market of foot and ankle treatments,” Zimmer Biomet foot & ankle GM Ben Joseph said in a press release.

The company said the Unite3D consists of a solid internal framework with a zero-prominence design and uniform compression across a series of 9 implant sizes.

“By offering foot and ankle surgeons a construct for osseointegration across the entire fusion site, the Unite3D Bridge Fixation System provides a stable and durable solution for fracture and osteotomy fixation and joint arthrodesis within the midfoot and hindfoot. Having replaced the plates, screws and surgical staples of traditional foot and ankle fusion, we also wanted to offer the intraoperative benefits of a streamlined procedure with easy-to-use and disposable surgical instruments,” Unite3D development collaborator and Texas Orthopaedic Associates MD Dr. John Earlysaid in a prepared statement.

In late January, Zimmer Biomet saw 4th-quarter profits plunge nearly 81%, but the orthopedics giant still managed to beat Wall Street’s earnings expectations by a nickel.

Warsaw, Ind.-based Zimmer Biomet posted profits of $29.7 million, or 14¢ per share, on sales of $1.93 billion for the 3 months ended Dec. 31, 2015. That amounts to a -80.7% bottom-line slide on sales growth of 58.1%, compared with Q4 2014.

Adjusted to exclude 1-time items, earnings per share were $2.09, 5¢ ahead of expectations on The Street.

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