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510(k) K221758

SMR Stemless Anatomic by Lima Corporate S.P.A. — Product Code PKC

K221758 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "SMR Stemless Anatomic". The FDA issued a decision of Substantially Equivalent on March 17, 2023. The device falls under product code PKC (Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained), a Class II device regulated under 21 CFR 888.3660. Lima Corporate S.P.A. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 2023
Date Received
June 16, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Replacement of the humeral head for total anatomic shoulder arthroplasty

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)
  • 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)
  • K223876 — SMR Shoulder System (February 3, 2023)

Other clearances for product code PKC

  • K254154 — FX V135 EASYTECH® Shoulder System (May 1, 2026)
  • K252129 — AETOS Shoulder System Stemless Humeral Prosthesis (October 3, 2025)
  • K243248 — INHANCE INTACT™ (December 23, 2024)
  • K241873 — OsseoFit Stemless Shoulder System (December 11, 2024)
  • K240716 — AETOS Shoulder System Stemless Humeral Prosthesis (November 20, 2024)
  • K220418 — Tornier Perform Humeral System – Stemless (September 14, 2022)
  • K213615 — Shoulder Innovations Total Shoulder System (March 11, 2022)
  • K212683 — GLOBAL ICON Stemless Shoulder System (January 19, 2022)
  • K203108 — Ignite Stemless Anatomic Shoulder System (July 16, 2021)
  • K201391 — Easytech® Anatomical Shoulder System (February 16, 2021)

FDA data resources