TEMA Elbow System— 510(k) K181362

Clearance details

Applicant

Lima Corporate S.P.A.

Product code

Code JDC

Device class

Class 2

Regulation

21 CFR 888.3150

Advisory panel

Orthopedic

Date received

2018-05-23

Decision date

2019-02-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Villanova Di San Daniele Del Friuli, IT

• K181307 — Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow2019-01-28
• K153398 — Comprehensive SRS/Nexel Elbow2016-02-03
• K150501 — Zimmer Nexel Total Elbow Ulnar Cement Diverter2015-04-23
• K123862 — ZIMMER NEXEL TOTAL ELBOW2013-03-12
• K090473 — DISCOVERY ELBOW - X-SMALL2009-03-25

• 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

1,050

Total

1,050

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-1261-2023 — TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)Class II·Ongoing·Limacorporate S.p.A·20230125

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181362.