EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER— 510(k) K093275

Name: FDA 510(k) clearance K093275
Creator: U.S. Food and Drug Administration
Published: 2010-05-27

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K093275 for EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER, Substantially Equivalent on 2010-05-27. Applicant: Exactech, Inc.. Device class: 2.

Clearance details

Applicant: Exactech, Inc.
Product code: Code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2009-10-19
Decision date: 2010-05-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHX

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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

More clearances from Exactech, Inc.

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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

Adverse events under product code PHX

product code PHX

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 →

Recalls naming K093275

K-number listed on FDA's recall record

Z-1416-2024 — Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
Z-1417-2024 — Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number 320-36-10, b) +2.5mm, Item Number 320-36-13; 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

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K093275.

Data sourced from openFDA. This site is unofficial and independent of the FDA.