Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
PHX — Predicate Candidate Screening
205 FDA 510(k) clearances under this product code; the 50 most recent screened below.
125 daysmedian FDA review time
267 days90th percentile
205clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260556 | Veritas Shoulder System | Restor3D | 2026-07-01 | 132 | 0 |
| K261683 | Augment Off-Axis Instrument System | Zimmer, Inc. | 2026-06-16 | 26 | 0 |
| K260102 | Tornier Perform Reversed Glenoid and Tornier Perform Reverse | Stryker Corporation (Tornier, Inc.) | 2026-06-12 | 150 | 0 |
| K261016 | MSS - Humeral reverse liners extension | Medacta International, SA | 2026-06-10 | 75 | 0 |
| K253992 | Veritas Reverse Total Shoulder System | Restor3D | 2026-05-07 | 146 | 0 |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere Baseplates | Biomet Orthopedics | 2026-04-15 | 258 | 0 |
| K260583 | Equinoxe® Shoulder System | Exactech, Inc. | 2026-04-14 | 53 | 0 |
| K254128 | InSet Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2026-04-13 | 112 | 0 |
| K253674 | Blueprint Patient-Specific Instrumentation | Stryker Corporation (Tornier, S.A.S.) | 2026-04-03 | 133 | 0 |
| K253624 | INHANCE™ Reverse Shoulder System | Depuy Ireland UC | 2026-03-11 | 113 | 0 |
| K250644 | MSS - Monobloc stem | Medacta International S.A. | 2026-02-03 | 336 | 1 |
| K252352 | SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral Sys | Lima Corporate S.P.A. | 2026-01-22 | 177 | 0 |
| K252567 | AltiVate Reverse® ADLC Glenosphere | Encore Medical L.P. | 2026-01-15 | 154 | 0 |
| K252516 | N22 EZ Glenosphere | Shoulder Innovations, Inc. | 2026-01-15 | 157 | 0 |
| K254003 | JARVIS Metaphyseal Stem | FH Industrie | 2026-01-09 | 25 | 0 |
| K252788 | Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) | Tornier, Inc. | 2026-01-08 | 128 | 0 |
| K250338 | MSS - Humeral reverse liners extension | Medacta International S.A. | 2025-10-31 | 267 | 0 |
| K253345 | JARVIS Diaphyseal Stem Standard | FH Industrie | 2025-10-29 | 29 | 0 |
| K252221 | Inset Reverse Total Shoulder System | Shoulder Innovations, Inc. | 2025-09-26 | 72 | 0 |
| K252411 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2025-08-28 | 27 | 0 |
| K252141 | AltiVate Reverse® Glenoid | Encore Medical L.P. | 2025-08-05 | 28 | 0 |
| K243448 | Equinoxe® Shoulder System | Exactech, Inc. | 2025-08-01 | 267 | 0 |
| K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.P.A. | 2025-07-03 | 203 | 0 |
| K243643 | restor3d Reverse Total Shoulder Arthroplasty System | Restor3D | 2025-05-19 | 174 | 0 |
| K251184 | AltiVate Reverse Shoulder System; RSP Shoulder System; SMR S | Encore Medical L.P. | 2025-05-16 | 30 | 0 |
| K242253 | JARVIS Glenoid Reverse Shoulder Prosthesis | FH Industrie | 2024-11-25 | 117 | 0 |
| K241491 | Blueprint Patient-Specific Instrumentation; Shoulder iD Prim | Stryker Corporation (Tornier, S.A.S.) | 2024-10-10 | 139 | 0 |
| K233482 | Equinoxe® Central Screw Baseplate System | Exactech, Inc. | 2024-07-18 | 266 | 0 |
| K233481 | AltiVate Reverse® Glenoid | Encore Medical L.P. | 2024-05-29 | 216 | 8 |
| K241043 | Augment Off-Axis Instrument System | Fix Surgical | 2024-05-15 | 28 | 5 |
| K240278 | Full Wedge Lateralized and Augmented Baseplates | Fx Shoulder USA, Inc. | 2024-05-15 | 104 | 0 |
| K234105 | Catalyst F1x Shoulder System | Catalyst Orthoscience, Inc. | 2024-04-05 | 101 | 0 |
| K233148 | Augment Off-Axis Instrument System | Fix Surgical | 2024-03-22 | 177 | 0 |
| K232265 | BLUEPRINT™ Patient Specific Instrumentation | Tornier S.A.S. | 2024-02-21 | 205 | 0 |
| K231445 | LINK Embrace Shoulder System - Reverse Configuration | Waldemar Link GmbH & Co. KG | 2023-11-16 | 182 | 0 |
| K231911 | Glenoid Reconstruction System – Full Wedge Baseplate | Medacta International S.A. | 2023-11-09 | 133 | 0 |
| K232583 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2023-09-20 | 26 | 0 |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapt | Exactech, Inc. | 2023-09-14 | 266 | 1 |
| K232226 | ARROW Off-Centred Humeral Insert | FH Industrie | 2023-08-29 | 33 | 0 |
| K223801 | FX V135(TM) Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2023-06-05 | 168 | 0 |
| K223655 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2023-05-09 | 154 | 0 |
| K230366 | Arthrex Univers Revers Monoblock Stem Size 4/33 | Arthrex, Inc. | 2023-04-10 | 59 | 0 |
| K214001 | Comprehensive® Shoulder System, Comprehensive® Reverse Shoul | Biomet Manufacturing Corp | 2023-03-15 | 449 | 0 |
| K223211 | INHANCETM Shoulder System – Humeral Stems and Stemless | Depuy Ireland UC | 2022-12-02 | 46 | 0 |
| K213459 | Glenoid Reconstruction System | Medacta International S.A. | 2022-11-23 | 392 | 0 |
| K222936 | Humeris® 135 Shoulder System | Fx Shoulder USA, Inc. | 2022-11-07 | 42 | 0 |
| K220914 | Tornier Perform Humeral System – Fracture | Tornier, Inc. | 2022-10-14 | 198 | 0 |
| K221467 | INHANCETM Reverse Glenoid Peripheral Posts | Depuy Ireland UC | 2022-08-31 | 103 | 0 |
| K213349 | Catalyst R1 Reverse Shoulder System | Catalyst Orthoscience, Inc. | 2022-06-23 | 258 | 0 |
| K213117 | FX V135 Shoulder Prosthesis | Fx Shoulder USA, Inc. | 2022-06-07 | 253 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda