On July 12, 2019, Berlin-based aap Implantate AG announced FDA 510(k) clearance of the company’s LOQTEQ VA foot plates 2.5. Altogether, the clearance is for 12 plates and 4 cortical screws.
aap Implantate Receives FDA Clearance for 12 Foot Plates/4 Screws
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According to the company, the system enables flexible treatment of fractures as well as correction of malpositions in the fore- and midfoot area. In addition, the polyaxial implants facilitate inserting angle-stable screws at different angles, “thereby improving flexibility within the application.”
The company says the combination of fracture compression and angular-stable locking in one surgical step is “unique and the foundation of LOQTEQ’s success.”
The system contains different fracture as well as arthrodesis and osteotomy plates for correcting joint malpositions of the foot. Revision plates for repeat foot operations complete the set.
The FDA documents state the system is intended for use in “stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of bones of the feet. Implants are intended for single use on adult human bone.”
The individual indications of use for each plate is lengthy, so we’ve included a link to the FDA page listing the indications.
The implants consist of a titanium-aluminum-vanadium alloy (TiAl6V4) and have different kinds of holes that can be used for fixation with polyaxial angular stable locking screws or standard cortical screws.
The DC-hole, according to the company, can be used for dynamic compression with a lag screw and the plates can be placed with a K-wire to fix the plate temporarily before the screws are tightened.
The company, founded in 1990 out of a unit of Mecron, a subsidiary of Johnson & Johnson, plans to launch the system in the U.S. at the beginning of 2020.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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