EQUINOXE REVERSE SHOULDER SYSTEM— 510(k) K063569

Clearance details

Applicant

Exactech, Inc.

Product code

Code PHX

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2006-11-29

Decision date

2007-02-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Gainesville, FL, US

• 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

• K260583 — Equinoxe® Shoulder System2026-04-14
• K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
• K243448 — Equinoxe® Shoulder System2025-08-01
• K243275 — Equinoxe® Scapula Fracture System2025-06-26
• K243839 — Alteon® HA Femoral Stems2025-03-10

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-2561-2025 — Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-DEG PE 42MM HUM LINER +2.5/Class II·Ongoing·Exactech, Inc.·20250815
• Z-1418-2024 — Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-1419-2024 — Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-1422-2024 — Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-1423-2024 — Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-1424-2024 — Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-1425-2024 — Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-0579-2024 — Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n) 320-46-13Class II·Ongoing·Exactech, Inc.·20231121
• Z-3019-2020 — Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.Class II·Terminated·Exactech, Inc.·20200824
• Z-3020-2020 — Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.Class II·Terminated·Exactech, Inc.·20200824
• Z-0012-2019 — Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgeryClass II·Ongoing·Exactech, Inc.·20180821
• Z-0900-2017 — Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw KitClass II·Terminated·Exactech, Inc.·20161025
• Z-2117-2012 — Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.Class II·Terminated·Exactech, Inc.·20120615

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063569.