Equinoxe® Shoulder System— 510(k) K260583

Name: FDA 510(k) clearance K260583
Creator: U.S. Food and Drug Administration
Published: 2026-04-14

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K260583 for Equinoxe® Shoulder System, Substantially Equivalent on 2026-04-14. Applicant: Exactech, Inc.. Device class: 2.

Summary

Exactech's Equinoxe Shoulder System is filed under product code PHX (Shoulder Prosthesis, Reverse Configuration). The record doesn't describe the system beyond its name and that code name.

Class II, 21 CFR 888.3660. It came in as a Traditional 510(k), and Orthopedic is both the classification panel and the review panel.

Exactech filed from Gainesville, Florida. Review took 53 calendar days (February 20 to April 14, 2026).

Clearance details

Applicant: Exactech, Inc.
Product code: Product code PHX
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2026-02-20
Decision date: 2026-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code PHX

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K263421 — Veritas Shoulder System2026-10-22
K263086 — AltiVate Reverse® Glenosphere with RAVN Technology2026-10-02
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

More clearances from Exactech, Inc.

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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
K240393 — Exactech® TRULIANT® Knee System2024-10-03

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 →

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