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510(k) K233712

PRIMA Humeral System; PRIMA TT Glenoid by Lima Corporate S.P.A. — Product Code MBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2024
Date Received
November 20, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3670
Review Panel
OR
Submission Type

Other clearances by Lima Corporate S.P.A.

  • K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System (January 22, 2026)
  • K251718 — ArTT Augments and Buttresses and Bone Screws (August 29, 2025)
  • 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)
  • 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 MBF

  • K251098 — Identity Revision Humeral Stems (August 11, 2025)
  • K250848 — Identity Shoulder System (July 2, 2025)
  • K240876 — Identity Shoulder System (June 12, 2024)
  • K231099 — SMR Hybrid Glenoid System (December 21, 2023)
  • K230831 — INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (November 13, 2023)
  • K231516 — INHANCE™ Shoulder System, Sterile Single Use Instrumentation (July 21, 2023)
  • K223876 — SMR Shoulder System (February 3, 2023)
  • K222427 — PRIMA TT Glenoid (October 6, 2022)
  • K213856 — Identity Shoulder System (September 15, 2022)
  • K212933 — INHANCETM Hybrid Anatomic Glenoid Implant (June 8, 2022)