SMR Shoulder System— 510(k) K161476

Clearance details

Applicant

Lima Corporate S.P.A.

Product code

Code KWT

Device class

Class 2

Regulation

21 CFR 888.3650

Advisory panel

Orthopedic

Date received

2016-05-27

Decision date

2016-06-24

Decision

Substantially Equivalent

Clearance type

Special

Location

Udine, IT

• K262173 — N22 Offset Humeral Head2026-09-08
• K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
• K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)2025-10-30
• K241944 — AGILON® XO Shoulder Replacement System2025-03-10
• K241817 — InSet Total Shoulder System2025-02-11

• K252352 — SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral System2026-01-22
• K251718 — ArTT Augments and Buttresses and Bone Screws2025-08-29
• K243826 — SMR Reverse HP Shoulder System2025-07-03
• K250980 — Physica System (Physica CR Porous Femoral components)2025-05-22
• K243615 — Physica Porous Femoral Components2024-12-18

Injury

2,467

Other

2

Total

2,469

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →