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FDA has ruled to classify the orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into class II (special controls).
The ruling is a follow up to a January 2018 request by Cartiva (since acquired by Wright Medical, which is itself slated to be acquired by Stryker) to FDA for accessory classification of Reusable Implantation Instruments used with the Cartiva Synthetic Cartilage Implant. The reusable instrument set received its initial FDA 510(k) clearance in 2018; a line extension containing two additional sizes was cleared earlier in September 2019. The synthetic cartilage implant received Premarket Approval in 2016.
In April 2018, FDA notified Cartiva that the instrument set would be recognized as class II, naming the generic type of device “orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation,” identified as hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation and placement of press-fit osteochondral implants that use no additional means of fixation (like suture fixation or adhesives).
FDA identified specific health risks associated with this device type, and also mitigation measures for these risks such as adverse tissue reaction, infection, implant malpositioning, etc. Special controls, on top of general controls, would address these risks.
FDA selects class II if general controls alone are insufficient to provide reasonable assurance of safety and effectiveness, but sufficient information exists to establish special controls that, when used with general controls that all devices have to meet, provide the reasonable assurance of safety/effectiveness for the device’s intended use.
The special controls for the subject device are:
1. Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position and place the implant.
2. The patient contacting components of the device must be demonstrated to be biocompatible.
3. Labeling must include:
(i) Identification of implant(s) and instruments which have been validated for use together; and
(ii) Validated methods and instructions for reprocessing any reusable parts.
