NEXUS® Hip Stem
FDA 510(k) K250444 · Microport Orthopedics, Inc.
510(k) numberK250444
Submission
- Device name
- NEXUS® Hip Stem
- Applicant
- Microport Orthopedics, Inc.
Arlington, TN, US - Received
- February 14, 2025
- Decision date
- May 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253948 | Momentum Acetabular Cup SystemLZO · Traditional | United Orthopedic Corporation | 09/02/2026SE |
| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various)LZO · Traditional | Waldemar Link GmbH & Co. KG | 07/06/2026SE |
| K260831 | Z1 Hip SystemLZO · Traditional | Zimmer, Inc. | 06/16/2026SE |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional | Zimmer, Inc. | 04/27/2026SE |
| K260037 | implantcast Packaging System UpdateLZO · Traditional | Implantcast GmbH | 03/30/2026SE |
| K252401 | implaFit® short stemsLZO · Traditional | Implantcast GmbH | 03/12/2026SE |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)LZO · Traditional | Maxx Orthopedics, Inc. | 01/15/2026SE |
| K250450 | Coated hip implantsLZO · Traditional | Medacta International S.A. | 09/19/2025SE |
| K243021 | Longboard Revision Hip StemLZO · Traditional | Signature Orthopaedics Pty, Ltd. | 08/07/2025SE |
| K251906 | Z1 Hip SystemLZO · Special | Zimmer, Inc. | 07/18/2025SE |
More from Zimmer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253728 | EVOLUTION® AM BIOFOAM® Tibial SystemMBH · Traditional | 08/21/2026SE |
| 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 |
| K213816 | MPO Hip InstrumentsJDI · Special | 01/05/2022SE |
Questions and answers
When was NEXUS® Hip Stem cleared by the FDA?
NEXUS® Hip Stem (K250444) received a 510(k) decision of Substantially Equivalent on May 15, 2025, 90 days after the submission was received.
What is the product code of K250444?
The FDA product code is LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.