Summit Total Hip System
FDA 510(k) K942891 · Kirschner Medical Corp.
510(k) numberK942891
Submission
- Device name
- Summit Total Hip System
- Applicant
- Kirschner Medical Corp.
Fair Lawn, NJ, US - Received
- June 20, 1994
- Decision date
- November 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
Other 510(k)s with product code MEH
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|---|---|---|---|
| K261576 | Icona Hip StemMEH · Traditional | Corin, Ltd. | 08/10/2026SE |
| K250375 | Allure Hip Stem and Intramedullary PlugsMEH · Traditional | Waldemar Link GmbH & Co. KG | 11/05/2025SE |
| K251166 | Mfinity Femoral SystemMEH · Traditional | Medacta International S.A. | 06/13/2025SE |
| 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 |
More from Signature Orthopaedics Pty, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K940537 | Kirschner(R) Modular Ii-C(Tm) Total Shoulder SystemKWT · Traditional | 08/29/1995SE |
| K936274 | Kirschner Performance Posterior Stabilized Total Knee SystemJWH · Traditional | 01/18/1995SE |
| K941486 | Integrity Total Hip System, Non-PorousJDI · Traditional | 09/20/1994SE |
| K933843 | Line Extension for Kirschner Performance Total Knee System, Porous CoatedJWH · Traditional | 08/05/1994SE |
| K935951 | Kirschner C-2 Osteocap Total Hip SystemJDI · Traditional | 07/18/1994SE |
| K935206 | Kirschner Integrity Acetabular Cup ModificationJDI · Traditional | 07/13/1994SE |
| K934589 | Kirschner Performance Total Knee System Porous CoatedJWH · Traditional | 07/13/1994SN |
| K934694 | Kirschner Zirconia Femoral HeadLZO · Traditional | 05/18/1994SE |
| K920188 | Threaded PinsMBJ · Traditional | 05/12/1993SE |
| K921837 | Medicam 900 Insufflator with AccessoriesHIF · Traditional | 02/05/1993SE |
Questions and answers
When was Summit Total Hip System cleared by the FDA?
Summit Total Hip System (K942891) received a 510(k) decision of Substantially Equivalent on November 2, 1994, 135 days after the submission was received.
What is the product code of K942891?
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.