Biocomposites, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
27
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0638-2021Class IIStimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids oNovember 12, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K251680Biosteon® ScrewFebruary 17, 2026
K242865Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerJune 12, 2025
K250521NanoBone® SBX Putty ; NanoBone® QDApril 7, 2025
K212721Genex Bone Graft SubstituteFebruary 4, 2022
K141830STIMULAN KIT, STIMULAN RAPID CUREJanuary 23, 2015
K082381GENEXNovember 14, 2008
K082383FORTOSS VITALSeptember 5, 2008
K073341GENEX PUTTYJuly 9, 2008
K081428MODIFICATION TO DOUBLEPLAY SUTURE ANCHORJune 20, 2008
K072127DOMINATORAugust 31, 2007
K071952GRAFTLOCK SCREW, ST SCREWAugust 14, 2007
K071091MODIFICATION TO BILOK SCREWMay 17, 2007
K071115MODIFICATION TO BILOK ST SCREWMay 17, 2007
K061949DOUBLEPLAY SUTURE ANCHORSeptember 25, 2006
K061311ALLOGRAN-RSeptember 22, 2006
K050170FORTOSS VITAL BONE GRAFT SUBSTITUTEAugust 26, 2005
K043514ALLOGRAN-N-BONE VOID FILLERJanuary 21, 2005
K040265LITTLE GRAFTER SCREWMay 28, 2004
K040600GENEX BONE GRAFT SUBSTITUTEMay 7, 2004
K033792BILOK ST SCREWMarch 1, 2004