Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics” (first 2016, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 91 days. Since 2017 the median was 84 days, against 132 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 |
|---|---|---|
| 2016 | 1 | 129 |
| 2017 | 2 | 93 |
| 2018 | 1 | 91 |
| 2019 | 2 | 173 |
| 2020 | 1 | 13 |
| 2021 | 1 | 28 |
| 2022 | 0 | — |
| 2023 | 1 | 70 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics took a median 84 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 5 | 5 |
| HSX | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | 2 | 2 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 | 1 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 1 | 1 |
Review panels
- Orthopedic (9)
Most recent Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233261 | Global Modular Replacement System | JDI | 2023-12-08 | 70 |
| K210893 | Restoration Anatomic Shell | LPH | 2021-04-22 | 28 |
| K203099 | Triathlon PKR System | HSX | 2020-10-27 | 13 |
| K191358 | Trident II Acetabular System | LPH | 2019-10-24 | 156 |
| K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System | LPH | 2019-03-19 | 190 |
| K180612 | Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts | HSX | 2018-06-07 | 91 |
| K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components | MBH | 2017-11-16 | 76 |
| K171768 | Trident® II Acetabular System | LPH | 2017-10-02 | 110 |
| K161569 | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws | LPH | 2016-10-14 | 129 |
Recalls
openFDA lists no recalls under a recalling firm named Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics.
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.
- Howmedica Corp. (409 510(k)s)
- Howmedica Osteonics Corp. (301 510(k)s)
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics (32 510(k)s)
- Howmedica Leibinger, Inc. (11 510(k)s)
- Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) (2 510(k)s)
- Howmedica Osteonics Corp (Dba Stryker Orthopaedics) (1 510(k)s)
- Howmedica Osteonics Corp. Dba Stryker Orthopeadics (1 510(k)s)
- Howmedica Osteonics, Dba Stryker Orthopaedics (1 510(k)s)
- Howmedica, Pfizer Medical Technology Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics?
FDA lists 9 510(k) clearances under the applicant name “Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics” (first 2016, latest 2023), across 4 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 Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics is 91 days. Since 2017: 84 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics?
The most frequent FDA product codes under this applicant name are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 5); HSX (Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer, 2); JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 1).
Next steps
- See all 9 Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics clearances with predicates and recalls
- Run predicate analysis for product code LPH, Howmedica Osteonics Corp. A.K.A. 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.