510(k) K262473

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

K262473 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 Oct 1, 2026. 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 39 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 1, 2026
Date Received
Jul 17, 2026
Clearance Type
Special
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
510(k)

Source: FDA 510(k) database entry for K262473. Report a data issue: hello@regdatalab.com.