510(k) K260975

Libertas Acetabular Liners (Acetabular Liner) by Maxx Orthopedics, Inc. — Product Code JDI

K260975 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Libertas Acetabular Liners (Acetabular Liner)". The FDA issued a decision of Substantially Equivalent on Oct 29, 2026. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Maxx Orthopedics, Inc. has 25 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 29, 2026
Date Received
Mar 24, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device Class
Class II
Regulation Number
888.3350
Review Panel
OR
Submission Type
510(k)

Source: FDA 510(k) database entry for K260975. Report a data issue: hello@regdatalab.com.