PROFEMUR® GLADIATOR® Cemented Classic Stem
FDA 510(k) K201519 · Microport Orthopedics, Inc.
510(k) numberK201519
Submission
- Device name
- PROFEMUR® GLADIATOR® Cemented Classic Stem
- Applicant
- Microport Orthopedics, Inc.
Arlington, TN, US - Received
- June 8, 2020
- Decision date
- December 10, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
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| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 08/02/2024SE |
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| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/26/2023SE |
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More from Depuy Ireland UC
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| K253728 | EVOLUTION® AM BIOFOAM® Tibial SystemMBH · Traditional | 08/21/2026SE |
| K250444 | NEXUS® Hip StemLZO · Traditional | 05/15/2025SE |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueJWH · Traditional | 02/18/2025SE |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO HipsLPH · Traditional | 04/18/2024SE |
| K240452 | Ceramic Femoral HeadLZO · Traditional | 04/12/2024SE |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral…KRO · Traditional | 04/01/2024SE |
| K233507 | EVOLUTION® Tibial ConesMBH · Traditional | 01/18/2024SE |
| K231947 | EVOLUTION® Cement KeelJWH · Traditional | 10/31/2023SE |
| K230563 | EVOLUTION® Hinge Knee SystemKRO · Traditional | 09/27/2023SE |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMBH · Special | 01/05/2022SE |
Questions and answers
When was PROFEMUR® GLADIATOR® Cemented Classic Stem cleared by the FDA?
PROFEMUR® GLADIATOR® Cemented Classic Stem (K201519) received a 510(k) decision of Substantially Equivalent on December 10, 2020, 185 days after the submission was received.
What is the product code of K201519?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.