Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biocomposites, Ltd. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
87 daysmedian FDA review time
224 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251680 | Biosteon® Screw | Biocomposites, Ltd. | 2026-02-17 | 263 | 0 |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Sp | Biocomposites, Ltd. | 2025-06-12 | 265 | 0 |
| K250521 | NanoBone® SBX Putty ; NanoBone® QD | Biocomposites, Ltd. | 2025-04-07 | 45 | 0 |
| K212721 | Genex Bone Graft Substitute | Biocomposites, Ltd. | 2022-02-04 | 161 | 0 |
| K141830 | STIMULAN KIT, STIMULAN RAPID CURE | Biocomposites, Ltd. | 2015-01-23 | 200 | 0 |
| K082381 | GENEX | Biocomposites, Ltd. | 2008-11-14 | 87 | 0 |
| K082383 | FORTOSS VITAL | Biocomposites, Ltd. | 2008-09-05 | 17 | 0 |
| K073341 | GENEX PUTTY | Biocomposites, Ltd. | 2008-07-09 | 224 | 0 |
| K081428 | MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR | Biocomposites, Ltd. | 2008-06-20 | 30 | 0 |
| K072127 | DOMINATOR | Biocomposites, Ltd. | 2007-08-31 | 29 | 0 |
| K071952 | GRAFTLOCK SCREW, ST SCREW | Biocomposites, Ltd. | 2007-08-14 | 29 | 0 |
| K071115 | MODIFICATION TO BILOK ST SCREW | Biocomposites, Ltd. | 2007-05-17 | 27 | 0 |
| K071091 | MODIFICATION TO BILOK SCREW | Biocomposites, Ltd. | 2007-05-17 | 29 | 0 |
| K061949 | DOUBLEPLAY SUTURE ANCHOR | Biocomposites, Ltd. | 2006-09-25 | 77 | 0 |
| K061311 | ALLOGRAN-R | Biocomposites, Ltd. | 2006-09-22 | 135 | 0 |
| K050170 | FORTOSS VITAL BONE GRAFT SUBSTITUTE | Biocomposites, Ltd. | 2005-08-26 | 212 | 0 |
| K043514 | ALLOGRAN-N-BONE VOID FILLER | Biocomposites, Ltd. | 2005-01-21 | 32 | 0 |
| K040265 | LITTLE GRAFTER SCREW | Biocomposites, Ltd. | 2004-05-28 | 113 | 0 |
| K040600 | GENEX BONE GRAFT SUBSTITUTE | Biocomposites, Ltd. | 2004-05-07 | 60 | 0 |
| K033792 | BILOK ST SCREW | Biocomposites, Ltd. | 2004-03-01 | 87 | 0 |
| K021551 | STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT | Biocomposites, Ltd. | 2002-11-01 | 172 | 0 |
| K021351 | BIOSTEON CROSS PIN | Biocomposites, Ltd. | 2002-10-17 | 171 | 1 |
| K003954 | STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT | Biocomposites, Ltd. | 2001-07-12 | 203 | 0 |
| K003641 | BIOLOK SCREW, BIOSTEON SCREW | Biocomposites, Ltd. | 2001-02-08 | 73 | 0 |
| K002070 | BIOLOK SCREW | Biocomposites, Ltd. | 2000-08-25 | 49 | 0 |
| K001724 | STIMULAN -CALCIUM SULFATE BONE VOID FILTER | Biocomposites, Ltd. | 2000-08-04 | 59 | 0 |
| K993238 | FORTOSS-CEMA | Biocomposites, Ltd. | 2000-01-14 | 109 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda