CONCORDE LIFT— 510(k) K171425

Clearance details

Applicant

Medos International SARL

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2017-05-15

Decision date

2017-07-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Lelocle, CH

• K261049 — SCALA® TL2026-08-20
• K261430 — TruLift Expandable System2026-07-28
• K253011 — Catalyft PL Expandable Interbody System2026-07-17
• K261020 — Symmetrix L Spinal System2026-07-14
• K253420 — Admiral ACP System +18 more2026-07-01

• K254157 — CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody2026-05-26
• K260240 — SYMPHONY Navigation Ready Instruments2026-03-27
• K253249 — TriALTIS Spine System2025-10-21
• K243249 — TriALTIS Spine System2025-01-17
• K241893 — CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays2024-09-16

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

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-1225-2019 — Concorde Lift, Expandable Interbody Device, spinal fusion implant Convex 9x21 (197809021C), 9x26 (197809026C), 11x21 (197811021C), 11x26 (197811026C), 9x21 (US197809021C), 9x26 (US197809026C)Class II·Terminated·DePuy Spine, Inc.·20190408
• Z-0848-2018 — Concorde Lift Driver Shaft AO. Used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine.Class II·Terminated·DePuy Orthopaedics, Inc.·20170726

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171425.