510(k) K253171

Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) by Maxx Orthopedics, Inc. — Product Code LZO

K253171 is an FDA 510(k) premarket notification submitted by Maxx Orthopedics, Inc. for the device "Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)". The FDA issued a decision of Substantially Equivalent on January 15, 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. Maxx Orthopedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2026
Date Received
September 26, 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