Stryker Trauma AG: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Stryker Trauma AG” (first 2013, latest 2017), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 57 days. 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 |
|---|---|---|
| 2013 | 11 | 79 |
| 2014 | 11 | 49 |
| 2015 | 2 | 54 |
| 2016 | 0 | — |
| 2017 | 1 | 70 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 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 AG took a median 70 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 16 | 16 |
| HWC | Screw, Fixation, Bone | 3 | 3 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 3 | 3 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 2 | 2 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 1 | 1 |
Review panels
- Orthopedic (25)
Most recent Stryker Trauma AG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172210 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) | KWS | 2017-10-02 | 70 |
| K153154 | Asnis JFX System | HWC | 2015-12-28 | 56 |
| K151178 | VariAx 2 Wrist Fusion System | HRS | 2015-06-24 | 51 |
| K143138 | AxSOS 3 Ti Locking Plate System | HRS | 2014-12-22 | 49 |
| K140961 | HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM | KTT | 2014-11-10 | 209 |
| K141992 | VARIAX 2 SYSTEM | HRS | 2014-08-07 | 16 |
| K141677 | VARIAX ELBOW PLATING SYSTEM | HRS | 2014-07-22 | 29 |
| K141204 | VARIAX 2 ONE THIRD TUBULAR PLATING SYSTEM | HRS | 2014-06-20 | 42 |
| K141121 | AXSOS 3 TI LOCKING PLATE SYSTEM | HRS | 2014-06-20 | 51 |
| K140565 | VARIAX 2 COMPRESSION PLATING SYSTEM | HRS | 2014-05-29 | 85 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Stryker Trauma AG.
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 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 Trauma GmbH (7 510(k)s)
- Stryker Corporate (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stryker Trauma AG?
FDA lists 25 510(k) clearances under the applicant name “Stryker Trauma AG” (first 2013, latest 2017), across 5 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 AG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stryker Trauma AG is 57 days.
Which FDA product codes appear under Stryker Trauma AG?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 16); HWC (Screw, Fixation, Bone, 3); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 3).
Next steps
- See all 25 Stryker Trauma AG clearances with predicates and recalls
- Run predicate analysis for product code HRS, Stryker Trauma AG'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.