510(k) K250444

NEXUS® Hip Stem by Microport Orthopedics, Inc. — Product Code LZO

K250444 is an FDA 510(k) premarket notification submitted by Microport Orthopedics, Inc. for the device "NEXUS® Hip Stem". The FDA issued a decision of Substantially Equivalent on May 15, 2025. The device falls under product code LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented), a Class II device regulated under 21 CFR 888.3353. Microport Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2025
Date Received
February 14, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Device Class
Class II
Regulation Number
888.3353
Review Panel
OR
Submission Type