AEQUALIS FX2— 510(k) K141345

Clearance details

Applicant

Tornier S.A.S.

Product code

Code PHX

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2014-05-22

Decision date

2014-11-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Montbonnot-Saint-Martin, FR

• K260556 — Veritas Shoulder System2026-07-01
• K261683 — Augment Off-Axis Instrument System2026-06-16
• K260102 — Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System2026-06-12
• K261016 — MSS - Humeral reverse liners extension2026-06-10
• K253992 — Veritas Reverse Total Shoulder System2026-05-07

• K232265 — BLUEPRINT Patient Specific Instrumentation2024-02-21
• K222510 — Blueprint Mixed Reality system2023-01-20
• DEN220012 — Tornier Pyrocarbon Humeral Head2022-12-16
• K203315 — BLUEPRINT Patient Specific Instrumentation2021-04-15
• K190521 — Aequalis Ascend Flex Shoulder System2019-06-12

Death

10

Injury

9,705

Malfunction

1,252

Total

10,967

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-0699-2017 — Aequalis Fx2 implant parts and instrument trays. Insert component : Part Numbers DWK204B-DWK206B, DWK224B-DWK226B, DWK230B-DWK23B, DWK244B-DWK246B, DWK250B-DWK252B, DWK264B-DWK266B, DWK270B-DWK272B. Stem Component: Part Number: DWK111B-DWK115B, DWK121B-DWK126B, DWK131B-DWK135B. Product Usage: Total or partial replacement of the Gleno-humeral articulation.Class II·Terminated·Tornier, Inc·20160919

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141345.