Wrightmedicaltechnologyinc: FDA filings under this applicant name
FDA lists 302 510(k) clearances under the applicant name “Wrightmedicaltechnologyinc” (first 1993, latest 2023), plus 1 PMA decision, across 46 product codes in 5 review panels. Median 510(k) review time under this name: 87 days. Since 2017 the median was 126 days, against 99 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.
Caduvo groups this applicant name under Stryker, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 12 | 81 |
| 2013 | 15 | 90 |
| 2014 | 19 | 52 |
| 2015 | 15 | 64 |
| 2016 | 3 | 205 |
| 2017 | 12 | 136 |
| 2018 | 7 | 113 |
| 2019 | 8 | 106 |
| 2020 | 2 | 225 |
| 2021 | 3 | 167 |
| 2022 | 1 | 90 |
| 2023 | 1 | 129 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Wrightmedicaltechnologyinc took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 45 | 45 |
| HWC | Screw, Fixation, Bone | 31 | 31 |
| MQV | Filler, Bone Void, Calcium Compound | 28 | 28 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 26 | 26 |
| HSN | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer | 21 | 21 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 20 | 20 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 12 | 12 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 11 | 11 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 11 | 11 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 11 | 11 |
Plus 36 more product codes.
Review panels
- Orthopedic (292)
- General and Plastic Surgery (6)
- General Hospital (3)
- Ear, Nose and Throat (1)
- Neurology (1)
Most recent Wrightmedicaltechnologyinc 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K222835 | Prophecy Preoperative Navigation Alignment System | HSN | 2023-01-27 | 129 |
| K213342 | PRO-DENSE LoVisc Bone Graft Substitute | MQV | 2022-01-05 | 90 |
| K212996 | Sterile PHALINX Hammertoe System | HWC | 2021-11-16 | 57 |
| K202815 | PROPHECY Preoperative Navigation Alignment System | HSN | 2021-03-10 | 167 |
| K201259 | ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System | HRS | 2021-01-08 | 242 |
| K200507 | PRO-DENSE LoVisc Bone Graft Substitute | MQV | 2020-10-21 | 233 |
| K193067 | The INBONE Total Ankle System, the INFINITY Total Ankle System and the INVISION Total Ankle Revision System | HSN | 2020-06-08 | 217 |
| K191393 | INFINITY Total Ankle System, INBONE Total Ankle System | HSN | 2019-08-22 | 90 |
| K190970 | PROSTEP TBI (Tailors Bunion Implant) System | HWC | 2019-08-13 | 123 |
| K183620 | PROSTEP TBC Implant System | HRS | 2019-06-06 | 162 |
292 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P960057 | PMA | ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL | 1998-05-27 |
Recalls
openFDA lists no recalls under a recalling firm named Wrightmedicaltechnologyinc.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Wrightmedicaltechnologyinc (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Wrightmedicaltechnologyinc?
FDA lists 302 510(k) clearances under the applicant name “Wrightmedicaltechnologyinc” (first 1993, latest 2023), plus 1 PMA decision, across 46 product codes in 5 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 Wrightmedicaltechnologyinc?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wrightmedicaltechnologyinc is 87 days. Since 2017: 126 days, versus 99 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Wrightmedicaltechnologyinc?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 45); HWC (Screw, Fixation, Bone, 31); MQV (Filler, Bone Void, Calcium Compound, 28).
Next steps
- See all 302 Wrightmedicaltechnologyinc clearances with predicates and recalls
- Run predicate analysis for product code HRS, Wrightmedicaltechnologyinc'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.