Summit DuoFix HA Coating
FDA 510(k) K193398 · DePuy Orthopaedics, Inc.
510(k) numberK193398
Submission
- Device name
- Summit DuoFix HA Coating
- Applicant
- DePuy Orthopaedics, Inc.
Warsaw, IN, US - Received
- December 6, 2019
- Decision date
- February 4, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
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| K251052 | Trivicta® Hip StemMEH · Traditional | Ortho Development Corp. | 05/22/2025SE |
| K242315 | Resolve Modular Revision Hip StemMEH · Traditional | United Orthopedic Corporation | 05/01/2025SE |
| K243839 | Alteon® HA Femoral StemsMEH · Traditional | Exactech, Inc. | 03/10/2025SE |
| K243162 | World LinerMEH · Special | Signature Orthopaedics Pty, Ltd. | 11/25/2024SE |
| K241472 | Icona Hip StemMEH · Traditional | Corin U.S.A. Limited | 10/03/2024SE |
| K241875 | TheRay Collared and Collarless Femoral StemMEH · Traditional | Nextstep Arthropedix | 09/13/2024SE |
| K241690 | Logical Liner; World Liner; World Knee PatellaMEH · Special | Signature Orthopaedics Pty, Ltd. | 08/01/2024SE |
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| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | 09/04/2026SE |
| K252887 | DePuy ATTUNE Knee SystemOIY · Traditional | 05/22/2026SE |
| K231503 | CUPTIMIZE AdvancedLLZ · Traditional | 08/22/2023SE |
| K213839 | DePuy Corail AMT Hip ProsthesisLZO · Special | 01/06/2022SE |
| K210167 | DELTA XTEND Reverse Shoulder SystemPHX · Special | 02/19/2021SE |
| K203167 | DePuy Corail AMT Hip ProsthesisLZO · Special | 11/19/2020SE |
| K202472 | ACTIS Duofix Hip ProsthesisLPH · Special | 10/21/2020SE |
| K201347 | DePuy ATTUNE Total Knee SystemOIY · Special | 06/18/2020SE |
| K193540 | TRUMATCH Personalized SolutionsJWH · Traditional | 06/16/2020SE |
| K192946 | DePuy Corail AMT Hip ProsthesisLZO · Special | 11/26/2019SE |
Questions and answers
When was Summit DuoFix HA Coating cleared by the FDA?
Summit DuoFix HA Coating (K193398) received a 510(k) decision of Substantially Equivalent on February 4, 2020, 60 days after the submission was received.
What is the product code of K193398?
The FDA product code is MEH – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate, a Class II (moderate risk) device regulated under 21 CFR 888.3353.