Biocomposites, Ltd.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Biocomposites, Ltd.” (first 2000, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 87 days. Since 2017 the median was 212 days, against 98 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 200 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 161 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 155 |
| 2026 | 1 | 263 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biocomposites, Ltd. took a median 212 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 11 | 11 |
| MQV | Filler, Bone Void, Calcium Compound | 11 | 11 |
| LYC | Bone Grafting Material, Synthetic | 3 | 3 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 1 | 1 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 1 | 1 |
Review panels
- Orthopedic (24)
- Dental (3)
Most recent Biocomposites, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251680 | Biosteon® Screw | MAI | 2026-02-17 | 263 |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer | KWL | 2025-06-12 | 265 |
| K250521 | NanoBone® SBX Putty ; NanoBone® QD | MQV | 2025-04-07 | 45 |
| K212721 | Genex Bone Graft Substitute | MQV | 2022-02-04 | 161 |
| K141830 | STIMULAN KIT, STIMULAN RAPID CURE | MQV | 2015-01-23 | 200 |
| K082381 | GENEX | MQV | 2008-11-14 | 87 |
| K082383 | FORTOSS VITAL | LYC | 2008-09-05 | 17 |
| K073341 | GENEX PUTTY | MQV | 2008-07-09 | 224 |
| K081428 | MODIFICATION TO DOUBLEPLAY SUTURE ANCHOR | HWC | 2008-06-20 | 30 |
| K072127 | DOMINATOR | HWC | 2007-08-31 | 29 |
17 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-11-12.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Biocomposites, Ltd. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07270380: Antibiotic Device for Osteomyelitis of the Extremities Pivotal Trial - Genex With Gentamicin. (Recruiting, started 2026-04)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biocomposites, Ltd.?
FDA lists 27 510(k) clearances under the applicant name “Biocomposites, Ltd.” (first 2000, latest 2026), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biocomposites, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biocomposites, Ltd. is 87 days. Since 2017: 212 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biocomposites, Ltd.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 11); MQV (Filler, Bone Void, Calcium Compound, 11); LYC (Bone Grafting Material, Synthetic, 3).
Next steps
- See all 27 Biocomposites, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Biocomposites, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.