Osteonics Corp.: FDA clearances and approvals
Osteonics Corp. has 178 FDA 510(k) clearances (first 1980, latest 2000), across 31 product codes in 2 review panels. Median 510(k) review time: 84 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 | 29 | 29 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 24 | 24 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 24 | 24 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 10 | 10 |
| HWC | Screw, Fixation, Bone | 8 | 8 |
| KWL | Prosthesis, Hip, Hemi-, Femoral, Metal | 8 | 8 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 7 | 7 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 7 | 7 |
| HRS | Plate, Fixation, Bone | 6 | 6 |
| JDK | Prosthesis, Hip, Cement Restrictor | 6 | 6 |
Plus 21 more product codes.
Review panels
- Orthopedic (174)
- General and Plastic Surgery (1)
Most recent Osteonics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983657 | OSTEONICS SERIES 7000 AD TIBIAL TRAY | HRY | 2000-04-06 | 535 |
| K980070 | OSTEONICS HA-COATED DEVICES | MEH | 1999-07-23 | 561 |
| K984375 | OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY | KWP | 1999-04-30 | 144 |
| K982798 | OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM | KWQ | 1999-03-25 | 227 |
| K984585 | OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE | KWL | 1999-02-24 | 62 |
| K990203 | OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS | MEH | 1999-02-18 | 28 |
| K990158 | OSTEONICS COMBINATION SCREW RING/BLOCKER | MNI | 1999-02-01 | 13 |
| K984302 | OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS | MNH | 1998-12-18 | 16 |
| K984353 | OSTEO 9MM IC TIBIAL NAIL | HSB | 1998-12-16 | 9 |
| K983502 | OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM | LPH | 1998-12-16 | 71 |
168 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Osteonics Corp..
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 Osteonics Corp. have?
Osteonics Corp. has 178 FDA 510(k) clearances (first 1980, latest 2000), across 31 product codes in 2 review panels.
How long does FDA take to clear Osteonics Corp.'s 510(k)s?
The median time from FDA receipt to decision across Osteonics Corp.'s cleared 510(k)s is 84 days.
What devices does Osteonics Corp. make?
Its most frequent FDA product codes are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 29); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 24); MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, 24).
Has Osteonics Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Osteonics Corp. Related entities may recall under other names.
Next steps
- See all 178 Osteonics Corp. clearances with predicates and recalls
- Run predicate analysis for product code JDI, Osteonics Corp.'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.