R120 Modular Total Hip System
FDA 510(k) K021822 · Osteoimplant Technology, Inc.
510(k) numberK021822
Submission
- Device name
- R120 Modular Total Hip System
- Applicant
- Osteoimplant Technology, Inc.
Hunt Valley, MD, US - Received
- June 4, 2002
- Decision date
- July 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K240418 | Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/12/2024SE |
| 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 |
| K220216 | C-Stem AMT LE ProsthesisJDI · Traditional | Depuy Ireland UC | 07/22/2022SE |
More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K040685 | Z - Series Modular Total Hip System Plasma CoatedLWJ · Traditional | 01/25/2005SE |
| K041443 | Oti Alumina Ceramic Femoral Head SystemLZO · Special | 11/16/2004SE |
| K040225 | Oti Alumina Ceramic Femoral Head SystemKWZ · Traditional | 05/06/2004SE |
| K032729 | Z-Series Modular Total Hip SystemLPH · Traditional | 12/03/2003SE |
| K030608 | Oti Bone Cement PlugJDK · Traditional | 06/12/2003SESU |
| K022779 | Oti Unicondular Interpositional SpacerHSH · Traditional | 11/20/2002SE |
| K012762 | MJS Posterior Stabilized Knee SystemHRY · Traditional | 12/11/2001SE |
| K011774 | R120 Modular Total Hip SystemJDI · Traditional | 09/05/2001SE |
| K003316 | Oti Ceramic Femoral Head SystemLZO · Traditional | 01/19/2001SE |
| K003199 | Triad II Modular Total Hip SystemLPH · Traditional | 01/10/2001SE |
Questions and answers
When was R120 Modular Total Hip System cleared by the FDA?
R120 Modular Total Hip System (K021822) received a 510(k) decision of Substantially Equivalent on July 23, 2002, 49 days after the submission was received.
What is the product code of K021822?
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.