EXACTECH EQUINOXE CAGE GLENOIDS— 510(k) K113309

Clearance details

Applicant

Exactech, Inc.

Product code

Code KWS

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2011-11-08

Decision date

2011-12-08

Decision

Substantially Equivalent

Clearance type

Special

Location

Gainesville, FL, US

• K260721 — Tornier Perform Advanced Glenoid2026-07-22
• K254084 — AETOS Shoulder System - CONCELOC Glenoids2026-04-06
• K252418 — Catalyst F1x Shoulder System2025-11-06
• K252416 — AETOS Shoulder System Meta Humeral Prosthesis Size 02025-10-29
• K241292 — MyShoulder Planner (5.3SSWPL)2025-01-30

• 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

6

Injury

9,652

Malfunction

1,385

Other

1

Total

11,044

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-1412-2024 — Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-1413-2024 — Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-1414-2024 — Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-1415-2024 — Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Right, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-32, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-33, c) 44, 47, 50, 53 head, Large, Item Number 314-13-34, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-35; Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-0459-2021 — Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, MediumClass II·Terminated·Exactech, Inc.·20201006
• Z-0460-2021 — Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, MediumClass II·Terminated·Exactech, Inc.·20201006
• Z-0414-2018 — Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.Class II·Terminated·Exactech, Inc.·20170831
• Z-0415-2018 — Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.Class II·Terminated·Exactech, Inc.·20170831

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113309.