Bioretec, Ltd.: FDA clearances and approvals
Bioretec, Ltd. has 9 FDA 510(k) clearances (first 2006, latest 2026), plus 1 De Novo decision, across 4 product codes in 1 review panel. Median 510(k) review time: 56 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 166 |
| 2014 | 1 | 30 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 157 |
Review time against the same product codes
Since 2017, Bioretec, Ltd.'s cleared 510(k)s took a median 157 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | 4 | 4 |
| HWC | Screw, Fixation, Bone | 4 | 4 |
| MAI | Fastener, Fixation, Biodegradable, Soft Tissue | 1 | 1 |
| QJD | Absorbable Metallic Bone Fixation Fastener | 1 | 0 |
Review panels
- Orthopedic (10)
Most recent Bioretec, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261057 | ActivaScrew Cannulated COM | HWC | 2026-09-04 | 157 |
| K133950 | ACTIVAPIN HT, FUSE LINK (PRIVATE LABLED FOR FOOTMIND, INC.) | HTY | 2014-01-22 | 30 |
| K130716 | BIORETEC ACTIVASCREW INTERFERENCE | MAI | 2013-08-28 | 166 |
| K080879 | ACTIVATM PRODUCT GROUP INCLUDING BIOABSORBABLE DEVICES ACTIVAPIN FUSION, ACTIVANAILTM CONICALTM | HTY | 2008-06-24 | 85 |
| K081392 | BIORETEC ACTIVASCREW, ACTIVASCREW CANNULATED AND ACTIVASCREW CANNULATED WITH ACTIVAPIN | HWC | 2008-06-18 | 30 |
| K072848 | ACTIVASCREW | HWC | 2007-11-02 | 29 |
| K071863 | ACTIVAPIN, NEXFIX RFS PIN, NEXFIX RESORBABLE FIXATION SYSTEM (RFS) | HTY | 2007-08-31 | 56 |
| K062980 | ACTIVASCREW | HWC | 2006-11-22 | 54 |
| K061164 | ACTIVAPIN | HTY | 2006-07-06 | 71 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN220030 | De Novo | Absorbable Metallic Bone Fixation Fastener | 2023-03-29 |
Recalls
openFDA lists no recalls under a recalling firm named Bioretec, Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Bioretec, Ltd. have?
Bioretec, Ltd. has 9 FDA 510(k) clearances (first 2006, latest 2026), plus 1 De Novo decision, across 4 product codes in 1 review panel.
How long does FDA take to clear Bioretec, Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Bioretec, Ltd.'s cleared 510(k)s is 56 days.
What devices does Bioretec, Ltd. make?
Its most frequent FDA product codes are HTY (Pin, Fixation, Smooth, 4); HWC (Screw, Fixation, Bone, 4); MAI (Fastener, Fixation, Biodegradable, Soft Tissue, 1).
Has Bioretec, Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Bioretec, Ltd. Related entities may recall under other names.
Next steps
- See all 9 Bioretec, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HTY, Bioretec, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.