510(k) K042021 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
EXACTECH EQUINOXE SHOULDER SYSTEM
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Oct 26, 2004 |
| Received | Jul 28, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042021
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2025 | Exactech, Inc. 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 component Open, Classified |
PHX | None listed |
| Nov 17, 2025 | Exactech, Inc. 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 component Open, Classified |
PHX | None listed |
| Nov 17, 2025 | Exactech, Inc. 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 componen Open, Classified |
PHX | None listed |
| Mar 29, 2024 | Exactech, Inc. 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, Sh Open, Classified |
KWS | None listed |
| Mar 29, 2024 | Exactech, Inc. 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, Shou Open, Classified |
KWS | None listed |
| Mar 29, 2024 | Exactech, Inc. 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, Shou Open, Classified |
KWS | None listed |
| Mar 29, 2024 | Exactech, Inc. 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, Open, Classified |
KWS | None listed |
| Nov 9, 2020 | Exactech, Inc. Equinoxe Humeral Stem, Primary, Press Fit, 11mm Open, Classified |
HSD | None listed |
| Apr 20, 2015 | Exactech, Inc. Equinoxe 44mm Short Humeral Head
Catalog Number 310-01-44.
Orthopedic shoulder implant component. Terminated |
KWS | None listed |
| Jul 31, 2012 | Exactech, Inc. Equinoxe Anatomic Replicator Plate
Intended for Primary and Reverse Total Shoulder Arthroplasty Terminated |
KWS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.