Orthomatrix, Inc.: FDA clearances and approvals
Orthomatrix, Inc. has 8 FDA 510(k) clearances (first 1984, latest 2001), across 5 product codes in 2 review panels. Median 510(k) review time: 128 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
Review panels
- Dental (4)
- Orthopedic (4)
Most recent Orthomatrix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010738 | CANNULATED PLUS SCREW SYSTEM | HWC | 2001-08-01 | 142 |
| K001254 | ORTHOMATRIX, INC. CERCLAGE SYSTEM | JDQ | 2000-12-13 | 238 |
| K992856 | MAGELLAN HUMERAL INTRAMEDULLARY NAIL | HSB | 2000-03-10 | 199 |
| K992850 | MAGELLAN TIBIAL INTRAMEDULLARY NAIL | HSB | 2000-03-10 | 199 |
| K852766 | HA-1000 & HA-500 HYDROXYLAPATITE TOOTH ROOT SUBSTI | LYC | 1985-10-21 | 115 |
| K852765 | HA-2000 HYDROXYLAPATITE | LYC | 1985-09-23 | 87 |
| K851367 | HA-1000 & HA-500 HYDROXYLAPATITE-MODIFICATION | DZE | 1985-05-21 | 46 |
| K842163 | RIDGEMATRIX 20/40 MESH, PERIOMATRIX | LYC | 1984-08-09 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Orthomatrix, Inc..
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 Orthomatrix, Inc. have?
Orthomatrix, Inc. has 8 FDA 510(k) clearances (first 1984, latest 2001), across 5 product codes in 2 review panels.
How long does FDA take to clear Orthomatrix, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Orthomatrix, Inc.'s cleared 510(k)s is 128 days.
What devices does Orthomatrix, Inc. make?
Its most frequent FDA product codes are LYC (Bone Grafting Material, Synthetic, 3); HSB (Rod, Fixation, Intramedullary And Accessories, 2); DZE (Implant, Endosseous, Root-Form, 1).
Has Orthomatrix, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Orthomatrix, Inc. Related entities may recall under other names.
Next steps
- See all 8 Orthomatrix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYC, Orthomatrix, Inc.'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.