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Amplitude Surgical receives 510(k) clearance for implant to address degenerative knee disorders
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Amplitude Surgical announced it has received 510(k) clearance from the FDA for its Anatomic implant for degenerative knee disorders, according to a company press release.
“This is a major milestone for Amplitude Surgical; it rewards the work of an entire team, from creative surgeons to engineers and all members of staff who have contributed to the development of this implant and the drafting of the FDA marketing approval file,” Olivier Jallabert, chairman and chief executive officer of Amplitude Surgical, said in the release. “Our Anatomic knee has been a success, with more than 20,000 surgeries carried out to date. This approval provides us with access to the U.S. market, worth over $4 billion. It illustrates the high quality of our implant, which is unquestionably suited to American standards, and will enable our U.S. subsidiary, Amplitude Orthopedics Corp., to launch its commercial activity.”
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