Biocomposites, Ltd.
FDA Regulatory Profile
Biocomposites, Ltd. appears in FDA public data with 1 recall, 27 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0638-2021, Class II) was initiated on November 12, 2020. Its most recent 510(k) clearance was granted on February 17, 2026.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 27
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0638-2021 | Class II | Stimulan Kit 10cc, Model 600-010 - Product Usage: intended for use as a bone void filler for voids o | November 12, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251680 | Biosteon® Screw | February 17, 2026 |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | June 12, 2025 |
| K250521 | NanoBone® SBX Putty ; NanoBone® QD | April 7, 2025 |
| K212721 | Genex Bone Graft Substitute | February 4, 2022 |
| K141830 | STIMULAN KIT, STIMULAN RAPID CURE | January 23, 2015 |
| K082381 | GENEX | November 14, 2008 |
| K082383 | FORTOSS VITAL | September 5, 2008 |
| K073341 | GENEX PUTTY | July 9, 2008 |
| K081428 | MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR | June 20, 2008 |
| K072127 | DOMINATOR | August 31, 2007 |
| K071952 | GRAFTLOCK SCREW, ST SCREW | August 14, 2007 |
| K071115 | MODIFICATION TO BILOK ST SCREW | May 17, 2007 |
| K071091 | MODIFICATION TO BILOK SCREW | May 17, 2007 |
| K061949 | DOUBLEPLAY SUTURE ANCHOR | September 25, 2006 |
| K061311 | ALLOGRAN-R | September 22, 2006 |
| K050170 | FORTOSS VITAL BONE GRAFT SUBSTITUTE | August 26, 2005 |
| K043514 | ALLOGRAN-N-BONE VOID FILLER | January 21, 2005 |
| K040265 | LITTLE GRAFTER SCREW | May 28, 2004 |
| K040600 | GENEX BONE GRAFT SUBSTITUTE | May 7, 2004 |
| K033792 | BILOK ST SCREW | March 1, 2004 |