Submission Details
| 510(k) Number | K240418 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 13, 2024 |
| Decision Date | April 12, 2024 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
Stryker Orthopaedics Hip Systems Labeling Update
Apr 2024
Decision
59d
Days
Class 2
Risk
About This 510(k) Submission
K240418 is an FDA 510(k) clearance for the Stryker Orthopaedics Hip Systems Labeling Update, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Howmedica Osteonics Corp., Dba Stryker Orthopaedics (Malwah, US). The FDA issued a Cleared decision on April 12, 2024, 59 days after receiving the submission on February 13, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.
Device Classification
| Product Code | JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3350 |
Manufacturer
Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Malwah, NJ · US
Julia Bally
31 submissions
31 cleared
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