Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies— 510(k) K162903

Clearance details

Applicant

Exactech, Inc.

Product code

Code KWT

Device class

Class 2

Regulation

21 CFR 888.3650

Advisory panel

Orthopedic

Date received

2016-10-17

Decision date

2017-02-27

Decision

Substantially Equivalent

Clearance type

Special

Location

Gainesville, FL, US

• K250713 — Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder Implants2025-12-01
• K251686 — Tornier Humeral Reconstruction System Max (Tornier HRS Max)2025-10-30
• K241944 — AGILON® XO Shoulder Replacement System2025-03-10
• K241817 — InSet Total Shoulder System2025-02-11
• K231657 — AGILON® XO Shoulder Replacement System2024-02-16

• K260583 — Equinoxe® Shoulder System2026-04-14
• 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

Injury

2,467

Other

2

Total

2,469

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 →