Insignia Hip Stem
FDA 510(k) K211703 · Stryker Orthopaedics
510(k) numberK211703
Submission
- Device name
- Insignia Hip Stem
- Applicant
- Stryker Orthopaedics
Mahwah, NJ, US - Received
- June 3, 2021
- Decision date
- August 16, 2021
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K191414 | EXETER Centralizer, EXETER 2.5mm PlugJDI · Traditional | 08/28/2019SE |
| K173499 | Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral HeadsJDG · Traditional | 03/19/2018SE |
| K173849 | Triathlon Total Knee SystemMBH · Traditional | 02/02/2018SE |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemJWH · Traditional | 10/30/2017SE |
| K153345 | Stryker Orthopaedics Hip Systems Labeling UpdateLPH · Traditional | 05/25/2016SE |
| K151264 | Restoration Anatomic ShellLPH · Traditional | 08/10/2015SE |
| K143085 | Stryker Orthopaedics Acetabular Shells, Femoral Stems and Total Hip Instruments for use…LPH · Traditional | 02/09/2015SE |
| K143393 | Triathlon Tritanium Cone AugmentsMBH · Traditional | 01/13/2015SE |
| K142462 | Restoration Anatomic ShellLPH · Traditional | 11/14/2014SE |
| K141056 | Triathlon Knee System Posterior Stabilized ComponentsMBH · Traditional | 08/05/2014SE |
Questions and answers
When was Insignia Hip Stem cleared by the FDA?
Insignia Hip Stem (K211703) received a 510(k) decision of Substantially Equivalent on August 16, 2021, 74 days after the submission was received.
What is the product code of K211703?
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.