510(k) K233481 · PHX Shoulder Prosthesis, Reverse Configuration
AltiVate Reverse® Glenoid
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, May 29, 2024 |
| Received | Oct 26, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233481
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2025 | Encore Medical, LP Brand Name: DJO SURGICAL
Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD
Model/Catalog Number: 804-06-311
Product Description: Material: S.S/Nitronic, Non-Sterile Open, Classified |
KWS | None listed |
| Sep 10, 2025 | Encore Medical, LP Brand Name: DJO SURGICAL
Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm
Model/Catalog Number: 804-06-312
Product Description: Material: S.S., Non Sterile Open, Classified |
KWS | None listed |
| Sep 10, 2025 | Encore Medical, LP Brand Name: DJO SURGICAL
Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE
Model/Catalog Number: 804-06-310
Product Description: Material: S.S/CoCrMo, Non-Sterile Open, Classified |
KWS | None listed |
| Sep 10, 2025 | Encore Medical, LP Brand Name: DJO SURGICAL
Product Name: FA S Altivate Reverse Glenoid Tray
Model/Catalog Number: None
Software Version: NA
Product Description: Enovis" shoulder devices are intended for treatment of pa Open, Classified |
FSM | None listed |
| Jun 23, 2025 | Encore Medical, LP Brand Name: ALTIVATE REVERSE
Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm
Model/Catalog Number: 506-04-126
Software Version: NA
Product Description: Encore Medical L.P. shoulder devices Open, Classified |
PHX | None listed |
| Jun 23, 2025 | Encore Medical, LP Brand Name: ALTIVATE REVERSE
Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 22mm
Model/Catalog Number: 506-04-122
Software Version: NA
Product Description: Encore Medical L.P. shoulder devices Open, Classified |
PHX | None listed |
| Jun 23, 2025 | Encore Medical, LP Brand Name: ALTIVATE REVERSE
Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 18mm
Model/Catalog Number: 506-04-118
Software Version: NA
Product Description: Encore Medical L.P. shoulder devices Open, Classified |
PHX | None listed |
| Jun 23, 2025 | Encore Medical, LP Brand Name: ALTIVATE REVERSE
Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 30mm
Model/Catalog Number: 506-04-130
Software Version: NA
Product Description: Encore Medical L.P. shoulder devices Open, Classified |
PHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.