SiNtx Technologies Inc (SINT)

[SmokerX]

https://www.accessdata.fda.gov/cdrh_docs/pdf18/K181761.pdf

Reference Devices:K151307
ICONACY™ I-Hip™

Materials:
Similar to the predicate. Both ceramic
heads meet ISO 6472-2, Implants for Surgery—
Ceramic Materials. Identical to the reference device,
the ICONACY™ I-Hip™ Ceramic Heads

Hmm, digging a bit into Iconacy they look to be based in Warsaw and operating out of Brazil. The devices seem to be an advancement in design.

Ceramic Heads are available in a variety of neck lengths and are produced by CoorsTek Medical under it’s brand name CeraSurf®. CoorsTek is a US based operations and this maintains ICONACY’S continuation and commitment to market it’s implants and instruments under the “Made In The USA” tradition.

https://www.accessdata.fda.gov/cdrh_docs/pdf15/K151307.pdf

Interesting the I-hip uses biolox delta as the substantially equivalent device. and the FDA distinguish this as The subject device is made of a similar material

--------

Now obviously Iconacy being based out of Warsaw marketing these devices in Brazil and the way the Zimmer 510K is worded is an indicator on this relationship. If AMDA was always a straight shill for Zimmer then why are they not located in Indiana like Iconacy? Who bought Ceramatec? Still operating out of Salt Lake city, Dallas metroplex and Colorado? You dont sell a thriving company. Biolox was sold off. I mean why even incorporate her into kyocera ceramics or coorstek? the equipment? the infrastructure? I guess. Tech sounds like she's a dead fish that died on the hill of the "color pink" trademark. I dont think she chose that hill to die on either.