OsteoCentric Technologies: FDA clearances and approvals
OsteoCentric Technologies has 12 FDA 510(k) clearances (first 2021, latest 2025), across 7 product codes in 2 review panels. Median 510(k) review time: 67 days. Since 2017 its median was 67 days, against 104 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 2 | 64 |
| 2022 | 2 | 52 |
| 2023 | 4 | 178 |
| 2024 | 1 | 30 |
| 2025 | 3 | 54 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, OsteoCentric Technologies's cleared 510(k)s took a median 67 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 4 | 4 |
| HRS | Plate, Fixation, Bone | 2 | 2 |
| OUR | Sacroiliac Joint Fixation | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| JDO | Device, Fixation, Proximal Femoral, Implant | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (11)
- Dental (1)
Most recent OsteoCentric Technologies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250520 | OsteoCentric Navigated Instruments System | OLO | 2025-10-27 | 248 |
| K251913 | OsteoCentric® UnifiMI® TCS Plating System | HRS | 2025-08-16 | 54 |
| K250494 | The OsteoCentric Bone Plate and Screw System | HRS | 2025-03-18 | 26 |
| K242691 | OsteoCentric Technologies Cannulated Fasteners and Nuts | HWC | 2024-10-09 | 30 |
| K230242 | OsteoCentric Dental Implant System | DZE | 2023-10-05 | 248 |
| K230226 | Integrity-SI® Fusion System | OUR | 2023-09-21 | 237 |
| K230595 | OsteoCentric ACL Fixation System | HWC | 2023-06-29 | 118 |
| K230764 | OsteoCentric Integrated Hip Fastener System | JDO | 2023-04-18 | 29 |
| K222512 | Integrity-SI Fusion System | OUR | 2022-09-12 | 24 |
| K221332 | OsteoCentric Spine MIS Pedicle Fastener System | NKB | 2022-07-28 | 80 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named OsteoCentric Technologies.
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 OsteoCentric Technologies have?
OsteoCentric Technologies has 12 FDA 510(k) clearances (first 2021, latest 2025), across 7 product codes in 2 review panels.
How long does FDA take to clear OsteoCentric Technologies's 510(k)s?
The median time from FDA receipt to decision across OsteoCentric Technologies's cleared 510(k)s is 67 days. Since 2017: 67 days, versus 104 days for all cleared 510(k)s in the same product codes.
What devices does OsteoCentric Technologies make?
Its most frequent FDA product codes are HWC (Screw, Fixation, Bone, 4); HRS (Plate, Fixation, Bone, 2); OUR (Sacroiliac Joint Fixation, 2).
Has OsteoCentric Technologies had device recalls?
openFDA lists no recalls under a recalling firm name matching OsteoCentric Technologies. Related entities may recall under other names.
Next steps
- See all 12 OsteoCentric Technologies clearances with predicates and recalls
- Run predicate analysis for product code HWC, OsteoCentric Technologies'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.