510(k) K251718

ArTT Augments and Buttresses and Bone Screws by Lima Corporate S.P.A. — Product Code LPH

K251718 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "ArTT Augments and Buttresses and Bone Screws". The FDA issued a decision of Substantially Equivalent on August 29, 2025. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Lima Corporate S.P.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2025
Date Received
June 4, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device Class
Class II
Regulation Number
888.3358
Review Panel
OR
Submission Type