Wright Medical: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Wright Medical” (first 1989, latest 2021), across 6 product codes in 4 review panels. Median 510(k) review time under this name: 175 days. Since 2017 the median was 190 days, against 110 days for all cleared 510(k)s in the same product codes. 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 | 1 | 227 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 2 | 159 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wright Medical took a median 190 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | 1 | 1 |
| HGM | System, Monitoring, Perinatal | 1 | 1 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
| JDR | Staple, Fixation, Bone | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| KYF | Implant, Eye Valve | 1 | 1 |
Review panels
- Orthopedic (3)
- Cardiovascular (1)
- Obstetrics and Gynecology (1)
- Ophthalmic (1)
Most recent Wright Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203228 | DART-FIRE EDGE Cannulated Screw System | HWC | 2021-05-11 | 190 |
| K203832 | FuseForce Flex Dynamic Compression System | JDR | 2021-05-07 | 128 |
| K162033 | SALVATION External Fixation System | KTT | 2017-03-06 | 227 |
| K905129 | BAERVELDT GLAUCOMA IMPLANT | KYF | 1991-02-11 | 89 |
| K901015 | WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC | DPW | 1990-11-05 | 245 |
| K892501 | WRIGHT MEDICAL FETASAFE | HGM | 1989-09-12 | 160 |
Recalls
openFDA lists no recalls under a recalling firm named Wright Medical.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Wright Linear Pump, Inc. (6 510(k)s)
- Wright Medical Technology, Inc. (Stryker) (3 510(k)s)
- Wright Medical Technology, Inc. (Stryker Corporation) (2 510(k)s)
- Wright Health Group , Ltd. (1 510(k)s)
- Wright Industries (1 510(k)s)
- Wright Laboratories, Inc. (1 510(k)s)
- Wright Medical Technology (1 510(k)s)
- Wright Therapy Products, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Wright Medical?
FDA lists 6 510(k) clearances under the applicant name “Wright Medical” (first 1989, latest 2021), across 6 product codes in 4 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 Wright Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wright Medical is 175 days. Since 2017: 190 days, versus 110 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wright Medical?
The most frequent FDA product codes under this applicant name are DPW (Flowmeter, Blood, Cardiovascular, 1); HGM (System, Monitoring, Perinatal, 1); HWC (Screw, Fixation, Bone, 1).
Next steps
- See all 6 Wright Medical clearances with predicates and recalls
- Run predicate analysis for product code DPW, Wright Medical'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.