Howmedica Osteonics Corp., Dba Stryker Orthopaedics: FDA clearances and approvals
Howmedica Osteonics Corp., Dba Stryker Orthopaedics has 32 FDA 510(k) clearances (first 2010, latest 2026), across 11 product codes in 2 review panels. Median 510(k) review time: 60 days. Since 2017 its median was 60 days, against 95 days for all cleared 510(k)s in the same product codes.
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 | 5 | 59 |
| 2026 | 3 | 62 |
Review time against the same product codes
Since 2017, Howmedica Osteonics Corp., Dba Stryker Orthopaedics's cleared 510(k)s took a median 60 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 5 | 5 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 5 | 5 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 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 |
| 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 |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component | JDI | 2024-08-02 | 49 |
22 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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Howmedica Osteonics Corp., Dba Stryker Orthopaedics have?
Howmedica Osteonics Corp., Dba Stryker Orthopaedics has 32 FDA 510(k) clearances (first 2010, latest 2026), across 11 product codes in 2 review panels.
How long does FDA take to clear Howmedica Osteonics Corp., Dba Stryker Orthopaedics's 510(k)s?
The median time from FDA receipt to decision across Howmedica Osteonics Corp., Dba Stryker Orthopaedics's cleared 510(k)s is 60 days. Since 2017: 60 days, versus 95 days for all cleared 510(k)s in the same product codes.
What devices does Howmedica Osteonics Corp., Dba Stryker Orthopaedics make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 5); KRO (Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, 5); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 5).
Has Howmedica Osteonics Corp., Dba Stryker Orthopaedics had device recalls?
openFDA lists no recalls under a recalling firm name matching Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Related entities may recall under other names.
Next steps
- See all 32 Howmedica Osteonics Corp., Dba Stryker Orthopaedics clearances with predicates and recalls
- Run predicate analysis for product code HRS, 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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.