Rex Implants Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

FDA has reviewed the information collected during the inspection as well as information on your website at www.reximplants.com; last accessed November 23, 2024, and determined that the devices listed above are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The aforementioned devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k).

Passage 2

The Instructions for Use for the PiezoImplant REX BL 2.9 implant system indicate that if there is implant mobility upon placement, the surgeon has the option to place the implant body deeper, whereas the Instructions for the Piezoimplant System, as cleared in K211872, stated that the implant body should be removed if there is mobility upon placement. This change represents a significantly modified risk.

Passage 3

However, according to the Instructions for Use for the PiezoImplant REX BL 2.9 implant system, the BL implant bodies are intended for placement in ridges that are greater than or equal to 3mm, which constitutes a major change or modification to its intended use.

Passage 4

The PiezoImplant REX BL 2.9 implant system is a bone level design with a different connection platform for attachment of abutment devices, which is a change in technology that could significantly affect the safety or effectiveness of the device.

Passage 5

We have reviewed our files and are unable to identify any FDA clearance or approval for the rexpanders and REX Mallet.

Passage 6

The K211872 submission only included abutments that are not intended to be used with a patient-specific top half. The titanium bases are intended to be used with a patient-specific top half that is cemented to the base. The titanium bases introduce a new biocompatibility concern compared to the devices cleared in the K211872 submission.