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510(k) K243615

Physica Porous Femoral Components by Lima Corporate S.P.A. — Product Code MBH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2024
Date Received
November 22, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3565
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)
  • 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 MBH

  • K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (March 9, 2026)
  • K253328 — GMK 3D Metal Tibial Tray Extension (February 26, 2026)
  • K253637 — Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing I (February 18, 2026)
  • K253239 — Active-V Total Knee System; World Total Knee System (December 23, 2025)
  • K253161 — Balanced Knee System TriMax Porous Femoral Components (December 19, 2025)
  • K252777 — Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (October 31, 2025)
  • K252044 — Triathlon® Total Knee System - Triathlon® Gold Femoral Components (October 24, 2025)
  • K243656 — U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella (July 31, 2025)
  • K250980 — Physica System (Physica CR Porous Femoral components) (May 22, 2025)
  • K243768 — iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System (March 27, 2025)