Dow Corning Wright: FDA filings under this applicant name
FDA lists 74 510(k) clearances under the applicant name “Dow Corning Wright” (first 1979, latest 1994), across 29 product codes in 7 review panels. Median 510(k) review time under this name: 100 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 24 | 24 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 7 | 7 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 5 | 5 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 4 | 4 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 3 | 3 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 3 | 3 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 2 | 2 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| JDL | Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) | 2 | 2 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 2 | 2 |
Plus 19 more product codes.
Review panels
- Orthopedic (63)
- Cardiovascular (3)
- Neurology (2)
- General and Plastic Surgery (2)
- General Hospital (1)
- Microbiology (1)
- Physical Medicine (1)
Most recent Dow Corning Wright 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K932210 | ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT | JWH | 1994-09-07 | 488 |
| K932911 | ORTHOLOC ADVANTIM L.S. TIBIAL COMPONENT | JWH | 1994-06-30 | 379 |
| K934354 | LACEY ALL POLYETHYLENE TIBIAL COMPONENT | JWH | 1994-06-03 | 269 |
| K932222 | SLT FEMORAL HEAD | LZO | 1994-05-27 | 385 |
| K932858 | ORTHOLOC ADVANTIM TIBIAL BASE COMPONENT | JWH | 1994-02-16 | 251 |
| K930228 | ORTHOLOC ADVANTIM TIBIAL STEM 5 DEGREE | JWH | 1993-11-30 | 315 |
| K925900 | LACEY REVISION FEMORAL COMPONENT | JWH | 1993-08-24 | 277 |
| K930189 | ORTHOLOC(R) ADVANTIM(TM) POSTERIOR STAB FEMOR COMP | JWH | 1993-08-06 | 204 |
| K930188 | ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT | JWH | 1993-08-03 | 201 |
| K930190 | ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP | JWH | 1993-08-02 | 200 |
64 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Dow Corning Wright.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Dow Corning Wright?
FDA lists 74 510(k) clearances under the applicant name “Dow Corning Wright” (first 1979, latest 1994), across 29 product codes in 7 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Dow Corning Wright?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dow Corning Wright is 100 days.
Which FDA product codes appear under Dow Corning Wright?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 24); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 7); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 5).
Next steps
- See all 74 Dow Corning Wright clearances with predicates and recalls
- Run predicate analysis for product code JWH, Dow Corning Wright's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.