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510(k) K251718

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

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

Other clearances by Lima Corporate S.P.A.

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  • K243826 — SMR Reverse HP Shoulder System (July 3, 2025)
  • K250980 — Physica System (Physica CR Porous Femoral components) (May 22, 2025)
  • K243615 — Physica Porous Femoral Components (December 18, 2024)
  • K234011 — AMF TT Cones (January 18, 2024)
  • K233712 — PRIMA Humeral System; PRIMA TT Glenoid (January 11, 2024)
  • K231099 — SMR Hybrid Glenoid System (December 21, 2023)
  • K231925 — MINIMA S System (July 11, 2023)
  • K221758 — SMR Stemless Anatomic (March 17, 2023)
  • K223876 — SMR Shoulder System (February 3, 2023)

Other clearances for product code LPH

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  • K252067 — Velora Acetabular System (December 5, 2025)
  • K252846 — TaperSet™ Hip System (November 20, 2025)
  • K251833 — EMPOWR Acetabular® Liner Extension (November 12, 2025)
  • K250989 — Stryker and Serf hip devices (July 25, 2025)
  • K243456 — ONVOY™ Acetabular System (June 6, 2025)
  • K242744 — Trinity EVO Acetabular Shell (June 5, 2025)
  • K242232 — Mpact 3D Metal Augments II (April 23, 2025)
  • K242045 — Initia T3 Acetabular Hemispherical Shell System (April 10, 2025)