LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,— 510(k) K100858

Clearance details

Applicant

Lima-Lto S.P.A.

Product code

Code KWT

Device class

Class 2

Regulation

21 CFR 888.3650

Advisory panel

Orthopedic

Date received

2010-03-26

Decision date

2010-12-10

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Winona Lake, IN, US

• 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

• K101263 — LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL STEMS, LIMA-LTO SMR SHOULDER SYSTEM - FINNED HUMERAL BODIES,2011-01-28

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 →

• Z-2539-2015 — SMR Shoulder/Spalla Trial Humeral Head diameter .42 mm, REF 9013.22.425; SMR Shoulder/Spalla Trial Humeral Head diameter .44 mm, REF 9013.22.445; SMR Shoulder/Spalla Trial Humeral Head diameter .46 mm, REF 9013.22.465; for use in shoulder implant surgery.Class II·Terminated·Limacorporate S.p.A·20150814
• Z-2540-2015 — SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.Class II·Terminated·Limacorporate S.p.A·20150814

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100858.