EXACTECH EQUINOXE SHOULDER SYSTEM— 510(k) K042021

Clearance details

Applicant

Exactech, Inc.

Product code

Code KWS

Device class

Class 2

Regulation

21 CFR 888.3660

Advisory panel

Orthopedic

Date received

2004-07-28

Decision date

2004-10-26

Decision

Substantially Equivalent

Clearance type

Traditional

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-0535-2026 — Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a componentClass II·Ongoing·Exactech, Inc.·20250905
• Z-0536-2026 — Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a componentClass II·Ongoing·Exactech, Inc.·20250905
• Z-0537-2026 — Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a componentClass II·Ongoing·Exactech, Inc.·20250905
• Z-1402-2024 — Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-1403-2024 — Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-01-12, b) Medium, Item Number 314-01-13, c) Large, Item Number 314-01-14, Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-1404-2024 — Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-1405-2024 — Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder ArthroplastyClass II·Ongoing·Exactech, Inc.·20240306
• Z-0884-2021 — Equinoxe Humeral Stem, Primary, Press Fit, 11mmClass II·Ongoing·Exactech, Inc.·20201109
• Z-1459-2015 — Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.Class II·Terminated·Exactech, Inc.·20150213
• Z-2115-2012 — Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder ArthroplastyClass II·Terminated·Exactech, Inc.·20120615

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K042021.