Stryker Orthopaedics: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Stryker Orthopaedics” (first 2004, latest 2021), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 100 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 | 0 | — |
| 2013 | 1 | 96 |
| 2014 | 2 | 88 |
| 2015 | 3 | 89 |
| 2016 | 1 | 188 |
| 2017 | 1 | 90 |
| 2018 | 2 | 86 |
| 2019 | 1 | 92 |
| 2020 | 0 | — |
| 2021 | 1 | 74 |
| 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 Orthopaedics took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 100 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 6 | 6 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 5 | 5 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 4 | 4 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 2 | 2 |
| MEH | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| HSD | Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | 1 | 1 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 1 | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| LOD | Bone Cement | 1 | 1 |
Review panels
- Orthopedic (24)
Most recent Stryker Orthopaedics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211703 | Insignia Hip Stem | MEH | 2021-08-16 | 74 |
| K191414 | EXETER Centralizer, EXETER 2.5mm Plug | JDI | 2019-08-28 | 92 |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads | JDG | 2018-03-19 | 126 |
| K173849 | Triathlon Total Knee System | MBH | 2018-02-02 | 45 |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | JWH | 2017-10-30 | 90 |
| K153345 | Stryker Orthopaedics Hip Systems Labeling Update | LPH | 2016-05-25 | 188 |
| K151264 | Restoration Anatomic Shell | LPH | 2015-08-10 | 89 |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use with the Direct Superior Approach | LPH | 2015-02-09 | 105 |
| K143393 | Triathlon Tritanium Cone Augments | MBH | 2015-01-13 | 48 |
| K142462 | Restoration Anatomic Shell | LPH | 2014-11-14 | 73 |
14 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 1 recall events; 6 initiated in the last five years. Most recent: 2024-04-15.
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.
Device clinical trials
An industry sponsor named Stryker Orthopaedics is the lead sponsor of 24 device studies on ClinicalTrials.gov (4 active or recruiting). Most recent:
- NCT05144191: Insignia™ Hip Stem Outcomes Study (Active not recruiting, started 2022-02-07)
- NCT04636190: Triathlon All-Polyethylene Tibia Outcomes Study (Active not recruiting, started 2021-07-02)
- NCT02999009: Trident II Tritanium Acetabular Shell Outcomes Study (Active not recruiting, started 2017-01-20)
- NCT05659329: Retrospective Simplex High Viscosity (HV) Bone Cement Study (Completed, started 2016-04-25)
- NCT02521103: Triathlon Tritanium Cone Augments Outcomes Study (Active not recruiting, started 2015-08)
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 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 Orthopaedics?
FDA lists 24 510(k) clearances under the applicant name “Stryker Orthopaedics” (first 2004, latest 2021), across 10 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 Orthopaedics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stryker Orthopaedics is 90 days. Since 2017: 90 days, versus 100 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Stryker Orthopaedics?
The most frequent FDA product codes under this applicant name are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 6); MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, 5); LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, 4).
Next steps
- See all 24 Stryker Orthopaedics clearances with predicates and recalls
- Run predicate analysis for product code LPH, Stryker Orthopaedics'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.