- FDA disclosed this week a warning letter to Conformis, a Massachusetts-based customized joint implant manufacturer, citing sterilization issues related to the company’s knee replacement systems.
- In the letter dated Dec. 10, FDA said the company failed to establish and maintain procedures for correcting and preventing recurrence of nonconforming product and other quality problems affecting its knee implants.
- Conformis, in an SEC filing Tuesday, said the letter addresses sterilization cycle failures for its Vaporized Hydrogen Peroxide (VHP) sterilizers. It said the sterility of products leaving its manufacturing facility has not been compromised.
Conformis, in its regulatory filing, said it is working to address the issues raised in the warning letter and stressed that FDA does not question the sterility of products themselves. The company said it uses VHP sterilizers as an alternative sterilization method for a small quantity of products.
"The company takes seriously the matters identified in the letter, has worked diligently to address the identified issues, and will respond to the FDA in a timely manner,” Conformis said.
The VHP sterilizers are used as a secondary sterilization method in limited circumstances, the company said. It does not anticipate any interruption in manufacturing, distribution or its new product launch schedule.
"The company believes that the matters identified by the FDA can be resolved without a material impact to the company’s financial results," Conformis said.
In its SEC filing in response to the FDA warning, Conformis said it has been planning to decommission and replace the VHP sterilizers and has already procured and validated a new onsite sterilization unit. It submitted a 510(k) premarket notification to FDA this month seeking authorization of the new unit.
But FDA said the 510(k) authorization that the company is seeking does not resolve the immediate concern of assuring sterility for product release. The agency said it received responses from Conformis dated Oct. 8 and Nov. 25 this year, following the agency’s Sept. 20 list of inspection observations, in which the company did not identify actions needed to correct the issues raised.
FDA gave Conformis 15 days to respond with how it plans to prevent recurrence of the violations and provide evidence that its sterilizers can pass a validation under routine operating conditions.
In October, Conformis announced it entered into an agreement with Stryker to receive $14 million upfront and up to $16 million in milestone payments for rights to its patient-specific instrumentation technology. Stryker plans to use the technology to develop customized instruments for use with Triathlon Total Knee System and other off-the-shelf knee implants. The deal gives Stryker a copy of the software code and manufacturing documents behind the technology, plus a 50% stake in the copyrights.