Stryker GmbH: FDA filings under this applicant name
FDA lists 55 510(k) clearances under the applicant name “Stryker GmbH” (first 2015, latest 2026), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 107 days. Since 2017 the median was 106 days, against 102 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 | 2 | 74 |
| 2016 | 5 | 140 |
| 2017 | 7 | 112 |
| 2018 | 6 | 112 |
| 2019 | 5 | 91 |
| 2020 | 6 | 98 |
| 2021 | 4 | 102 |
| 2022 | 7 | 127 |
| 2023 | 6 | 109 |
| 2024 | 2 | 77 |
| 2025 | 3 | 106 |
| 2026 | 2 | 66 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Stryker GmbH took a median 106 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 102 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 21 | 21 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 9 | 9 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 7 | 7 |
| HWC | Screw, Fixation, Bone | 6 | 6 |
| KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 5 | 5 |
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
| JDR | Staple, Fixation, Bone | 2 | 2 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
Review panels
- Orthopedic (55)
Most recent Stryker GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261481 | Pangea Femur Reconstruction System | HSB | 2026-06-29 | 55 |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | HSB | 2026-02-03 | 76 |
| K253202 | Hoffmann LRF System | KTT | 2025-12-19 | 84 |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | HSB | 2025-08-20 | 106 |
| K250163 | T2 Alpha Femur Retrograde Nailing System | HSB | 2025-08-13 | 204 |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System | HRS | 2024-10-06 | 51 |
| K233919 | VariAx 2 Distal Radius System | HRS | 2024-03-25 | 103 |
| K233741 | Hoffmann LRF System | KTT | 2023-12-21 | 29 |
| K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System | HRS | 2023-08-18 | 109 |
| K231257 | Pangea Utility Plating System, Pangea Platform | HRS | 2023-08-18 | 109 |
45 earlier clearances. See the full list in Caduvo.
Recalls
75 product recalls in 21 recall events; 15 initiated in the last five years. Most recent: 2026-07-01.
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. (297 510(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 (12 510(k)s)
- Stryker Trauma GmbH (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stryker GmbH?
FDA lists 55 510(k) clearances under the applicant name “Stryker GmbH” (first 2015, latest 2026), across 9 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 GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stryker GmbH is 107 days. Since 2017: 106 days, versus 102 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Stryker GmbH?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 21); HSB (Rod, Fixation, Intramedullary And Accessories, 9); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 7).
Next steps
- See all 55 Stryker GmbH clearances with predicates and recalls
- Run predicate analysis for product code HRS, Stryker 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 (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.