Stryker Trauma GmbH: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Stryker Trauma GmbH” (first 2015, latest 2020), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 106 days. Since 2017 the median was 109 days, against 126 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 |
|---|---|---|
| 2015 | 1 | 95 |
| 2016 | 0 | — |
| 2017 | 1 | 127 |
| 2018 | 2 | 113 |
| 2019 | 1 | 29 |
| 2020 | 2 | 99 |
| 2021 | 0 | — |
| 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 Stryker Trauma GmbH took a median 109 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 126 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 5 | 5 |
| HTY | Pin, Fixation, Smooth | 2 | 2 |
Review panels
- Orthopedic (7)
Most recent Stryker Trauma GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200869 | Gamma3 System | HSB | 2020-07-22 | 112 |
| K193308 | T2 Alpha Tibia Nailing System, IMN Screws System | HSB | 2020-02-23 | 86 |
| K191271 | T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System | HSB | 2019-06-11 | 29 |
| K180436 | T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System | HSB | 2018-06-06 | 106 |
| K172774 | T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System | HSB | 2018-01-12 | 120 |
| K170418 | Stryker SonicPin System | HTY | 2017-06-20 | 127 |
| K143063 | Stryker SonicPin System, Stryker SonicAnchor System | HTY | 2015-01-27 | 95 |
Recalls
openFDA lists no recalls under a recalling firm named Stryker Trauma GmbH.
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.
- Stryker Corp. (352 510(k)s)
- Stryker Endoscopy (102 510(k)s)
- Stryker Spine (75 510(k)s)
- Stryker Instruments (75 510(k)s)
- Stryker Sustainability Solutions (34 510(k)s)
- Stryker Neurovascular (33 510(k)s)
- Stryker Trauma AG (25 510(k)s)
- Stryker Orthopaedics (24 510(k)s)
- Stryker Leibinger GmbH & Co KG (22 510(k)s)
- Stryker Medical (14 510(k)s)
- Stryker Leibinger (13 510(k)s)
- Stryker Corporate (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stryker Trauma GmbH?
FDA lists 7 510(k) clearances under the applicant name “Stryker Trauma GmbH” (first 2015, latest 2020), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Stryker Trauma GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stryker Trauma GmbH is 106 days. Since 2017: 109 days, versus 126 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Stryker Trauma GmbH?
The most frequent FDA product codes under this applicant name are HSB (Rod, Fixation, Intramedullary And Accessories, 5); HTY (Pin, Fixation, Smooth, 2).
Next steps
- See all 7 Stryker Trauma GmbH clearances with predicates and recalls
- Run predicate analysis for product code HSB, Stryker Trauma GmbH'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.