FDA WARNING_LETTER - Crocker Spinal Technologies Inc

The FDA issued a Warning Letter to Nexus CMF regarding its TMJ Fossa-Eminence/Condylar Prosthesis System (P000023) and TMJ Fossa-Eminence Prosthesis (P000035). These devices were subject to a February 4, 2011, postmarket surveillance order (PS110002) under Section 522 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 360l) and 21 CFR Part 822, due to Medical Device Reports (MDRs) indicating explantation within three years, significantly shorter than the expected five-year lifespan.

Nexus CMF (formerly TMJ Medical) has a history of non-compliance since 2011, repeatedly submitting inadequate study plans and failing to adhere to the terms of a conditional hold placed on the study. Specifically, the firm failed to notify FDA within 10 days of initiating manufacturing in late (b)(4) 2012, despite a condition that the 522 order was on hold until such notification and submission of a study plan. The acquisition of TMJ Medical by Nexus CMF in July 2013 did not absolve the obligation.

Ongoing deficiencies in submitted study plans, noted in FDA letters from August 2013 to November 2014