Biostructures, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Biostructures, LLC” (first 2010, latest 2016), across 1 product code in 1 review panel. Median 510(k) review time under this name: 191 days. 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 | 1 | 191 |
| 2015 | 1 | 154 |
| 2016 | 1 | 264 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MQV | Filler, Bone Void, Calcium Compound | 5 | 5 |
Review panels
- Orthopedic (5)
Most recent Biostructures, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160446 | MCP Bone Putty | MQV | 2016-11-07 | 264 |
| K142276 | MCS Bone Graft | MQV | 2015-01-16 | 154 |
| K132071 | BIOACTIVE BONE GRAFT PUTTY | MQV | 2014-01-10 | 191 |
| K112857 | INTERFACE BONE VOID FILLER | MQV | 2011-12-13 | 74 |
| K092541 | INTERFACE | MQV | 2010-11-09 | 447 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2011-01-31.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Biostructures, LLC?
FDA lists 5 510(k) clearances under the applicant name “Biostructures, LLC” (first 2010, latest 2016), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biostructures, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biostructures, LLC is 191 days.
Which FDA product codes appear under Biostructures, LLC?
The most frequent FDA product codes under this applicant name are MQV (Filler, Bone Void, Calcium Compound, 5).
Next steps
- See all 5 Biostructures, LLC clearances with predicates and recalls
- Run predicate analysis for product code MQV, Biostructures, LLC'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.