Osteo Technology, Inc.: FDA clearances and approvals
Osteo Technology, Inc. has 18 FDA 510(k) clearances (first 1992, latest 1994), across 11 product codes in 2 review panels. Median 510(k) review time: 253 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 |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 7 | 7 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| GRF | Antiserum, Cf, Rubeola | 1 | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 1 | 1 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 1 | 1 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 1 | 1 |
| KWT | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (17)
- Microbiology (1)
Most recent Osteo Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K926156 | REPLICA(TM) TOTAL HIP SYSTEM | LPH | 1994-03-09 | 457 |
| K922859 | ANATOMICAL TYPE KNEE SYSTEM | JWH | 1993-09-23 | 476 |
| K922869 | TOTAL CONDYLAT TYPE KNEE SYSTEM | JWH | 1993-07-13 | 404 |
| K925447 | OTI ORTHOPEDIC WIRE SYSTEM | JDQ | 1993-06-29 | 244 |
| K926213 | MODIFIED ZICKEL INTRAMEDULLARY ROD SYSTEM | HSB | 1993-06-17 | 189 |
| K922861 | BIOMETRIC SCREW FIXATION CUP | JDL | 1993-05-12 | 342 |
| K922870 | THREE SPIKE CUP | GRF | 1993-04-08 | 308 |
| K925301 | OTI ORTHOPEDIC FASTENER SYSTEM | HTY | 1993-03-16 | 146 |
| K922682 | AMERICANA HIP PROTHESIS | JDG | 1993-03-16 | 285 |
| K922871 | UNIFIT FEMORAL STEM | JDI | 1993-02-12 | 253 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Osteo Technology, 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 Osteo Technology, Inc. have?
Osteo Technology, Inc. has 18 FDA 510(k) clearances (first 1992, latest 1994), across 11 product codes in 2 review panels.
How long does FDA take to clear Osteo Technology, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Osteo Technology, Inc.'s cleared 510(k)s is 253 days.
What devices does Osteo Technology, Inc. make?
Its most frequent FDA product codes are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 7); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 2); GRF (Antiserum, Cf, Rubeola, 1).
Has Osteo Technology, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Osteo Technology, Inc. Related entities may recall under other names.
Next steps
- See all 18 Osteo Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Osteo Technology, 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.