Howmedica Osteonics Corp., Dba Stryker Orthopaedics: FDA filings under this applicant name
FDA lists 33 510(k) clearances under 3 spellings of the applicant name “Howmedica Osteonics Corp., Dba Stryker Orthopaedics” (first 2010, latest 2026), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 61 days. Since 2017 the median was 62 days, against 95 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 | 2 | 94 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 2 | 69 |
| 2021 | 2 | 60 |
| 2022 | 4 | 60 |
| 2023 | 5 | 59 |
| 2024 | 5 | 76 |
| 2025 | 6 | 77 |
| 2026 | 3 | 62 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Howmedica Osteonics Corp., Dba Stryker Orthopaedics took a median 62 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 95 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 6 | 6 |
| HRS | Plate, Fixation, Bone | 5 | 5 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 5 | 5 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 4 | 4 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 4 | 4 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 3 | 3 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 2 | 2 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 1 | 1 |
| KRR | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Howmedica Osteonics Corp., Dba Stryker Orthopaedics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | KRO | 2026-08-06 | 62 |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar Component | LPH | 2026-07-10 | 56 |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | MBH | 2026-02-18 | 91 |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella; Triathlon® Symmetric Patella; Triathlon® Asymmetric Patella; Scorpio® Universal Dome Patella; Triathlon® Hinge Bumper | KRO | 2025-12-15 | 95 |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | MBH | 2025-10-24 | 116 |
| K251665 | Triathlon® Hinge Knee System | KRO | 2025-07-25 | 56 |
| K250989 | Stryker and Serf hip devices | LPH | 2025-07-25 | 116 |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior Stabilized Tibial Insert; Scorpio-Flex Cruciate Retaining Tibial Insert; Scorpio NRG Tibial Bearing Insert Cruciate Retaining Insert; Scorpio NRG Tibial Bearing Insert Posteriorly Stabilized Insert | JWH | 2025-02-06 | 56 |
| K243784 | Stryker Orthopaedics Hip Devices Labeling Update | LPH | 2025-02-06 | 59 |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon Tritanium Tibial Baseplate; Triathlon Low Profile Tibial Tray; Triathlon Metal Backed Patella; Triathlon Partial Knee System; Avon Patello-femoral Joint Prosthesis; Restoris Multi-Compartmental Knee System | JWH | 2024-12-04 | 76 |
23 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Howmedica Osteonics Corp., Dba 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.
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics (31)
- Howmedica Osteonics Corp (Dba Stryker Orthopaedics) (1)
- Howmedica Osteonics Corp. dba Stryker Orthopaedics (1)
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 Leibinger, Inc. (11 510(k)s)
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (9 510(k)s)
- Howmedica Osteonics Corp. (Aka Stryker Orthopaedics) (2 510(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., Dba Stryker Orthopaedics?
FDA lists 33 510(k) clearances under 3 spellings of the applicant name “Howmedica Osteonics Corp., Dba Stryker Orthopaedics” (first 2010, latest 2026), across 11 product codes in 2 review panels. 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., Dba Stryker Orthopaedics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Howmedica Osteonics Corp., Dba Stryker Orthopaedics is 61 days. Since 2017: 62 days, versus 95 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Howmedica Osteonics Corp., Dba Stryker Orthopaedics?
The most frequent FDA product codes under this applicant name are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 6); HRS (Plate, Fixation, Bone, 5); KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, 5).
Next steps
- See all 33 Howmedica Osteonics Corp., Dba Stryker Orthopaedics clearances with predicates and recalls
- Run predicate analysis for product code LPH, Howmedica Osteonics Corp., Dba 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 (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.