510(k) K241043 ยท PHX Shoulder Prosthesis, Reverse Configuration
Augment Off-Axis Instrument System
| Applicant | Fix Surgical, Conshohocken PA, US |
| Decision | Substantially Equivalent, May 15, 2024 |
| Received | Apr 17, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K241043
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide, Model/Catalog Number: 110040240 Open, Classified |
PHX | None listed |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide
Model/Catalog Number: 110040241 Open, Classified |
PHX | None listed |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide
Model/Catalog Number: 110040242 Open, Classified |
PHX | None listed |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040444 Open, Classified |
PHX | None listed |
| Jun 23, 2026 | Zimmer, Inc. Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Number: 110040476 Open, Classified |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.