Company · GB
Biocomposites, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2026. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (1 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 17, 2026 | K251680 | Biosteon® Screw Biocomposites, Ltd., GB | MAI |
| Jun 12, 2025 | K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer Biocomposites, Ltd., GB | KWL |
| Apr 7, 2025 | K250521 | NanoBone® SBX Putty ; NanoBone® QD Biocomposites, Ltd., GB | MQV |
| Feb 4, 2022 | K212721 | Genex Bone Graft Substitute Biocomposites, Ltd., GB | MQV |
| Jan 23, 2015 | K141830 | STIMULAN KIT, STIMULAN RAPID CURE Biocomposites, Ltd., GB | MQV |
| Nov 14, 2008 | K082381 | GENEX Biocomposites, Ltd., GB | MQV |
| Sep 5, 2008 | K082383 | FORTOSS VITAL Biocomposites, Ltd., GB | LYC |
| Jul 9, 2008 | K073341 | GENEX PUTTY Biocomposites, Ltd., GB | MQV |
| Jun 20, 2008 | K081428 | MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR Biocomposites, Ltd., GB | HWC |
| Aug 31, 2007 | K072127 | DOMINATOR Biocomposites, Ltd., GB | HWC |
| Aug 14, 2007 | K071952 | GRAFTLOCK SCREW, ST SCREW Biocomposites, Ltd., GB | HWC |
| May 17, 2007 | K071115 | MODIFICATION TO BILOK ST SCREW Biocomposites, Ltd., GB | HWC |
| May 17, 2007 | K071091 | MODIFICATION TO BILOK SCREW Biocomposites, Ltd., GB | HWC |
| Sep 25, 2006 | K061949 | DOUBLEPLAY SUTURE ANCHOR Biocomposites, Ltd., GB | HWC |
| Sep 22, 2006 | K061311 | ALLOGRAN-R Biocomposites, Ltd., GB | MQV |
| Aug 26, 2005 | K050170 | FORTOSS VITAL BONE GRAFT SUBSTITUTE Biocomposites, Ltd., GB | LYC |
| Jan 21, 2005 | K043514 | ALLOGRAN-N-BONE VOID FILLER Biocomposites, Ltd., GB | MQV |
| May 28, 2004 | K040265 | LITTLE GRAFTER SCREW Biocomposites, Ltd., GB | HWC |
| May 7, 2004 | K040600 | GENEX BONE GRAFT SUBSTITUTE Biocomposites, Ltd., GB | MQV |
| Mar 1, 2004 | K033792 | BILOK ST SCREW Biocomposites, Ltd., GB | HWC |
| Nov 1, 2002 | K021551 | STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT Biocomposites, Ltd., GB | MQV |
| Oct 17, 2002 | K021351 | BIOSTEON CROSS PIN Biocomposites, Ltd., GB | HWC |
| Jul 12, 2001 | K003954 | STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT Biocomposites, Ltd., GB | MQV |
| Feb 8, 2001 | K003641 | BIOLOK SCREW, BIOSTEON SCREW Biocomposites, Ltd., GB | HWC |
| Aug 25, 2000 | K002070 | BIOLOK SCREW Biocomposites, Ltd., GB | HWC |
| Aug 4, 2000 | K001724 | STIMULAN -CALCIUM SULFATE BONE VOID FILTER Biocomposites, Ltd., GB | MQV |
| Jan 14, 2000 | K993238 | FORTOSS-CEMA Biocomposites, Ltd., GB | LYC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2020 | Biocomposites, Ltd. Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Terminated |
MQV | K141830 |