Tornier Simpliciti® Shoulder System
Model 7122873 · TORNIER, INC. · DI 00846832090464
PKC — Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained · Class II · 21 CFR 888.3660
UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (2)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Injury: 2
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1 |
| 2019-03 | 0 | 1 |
| 2019-05 | 0 | 1 |
| 2019-08 | 0 | 1.67 |
| 2019-10 | 0 | 1.17 |
| 2019-11 | 0 | 1.67 |
| 2019-12 | 0 | 1 |
| 2020-01 | 0 | 1 |
| 2020-03 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-08 | 0 | 1 |
| 2020-09 | 0 | 1 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 1 |
| 2021-06 | 0 | 1 |
| 2021-08 | 0 | 1 |
| 2021-09 | 0 | 1 |
| 2021-10 | 0 | 2.2 |
| 2021-11 | 0 | 2.5 |
| 2021-12 | 0 | 7 |
| 2022-01 | 0 | 2.25 |
| 2022-02 | 0 | 1.75 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 3 |
| 2022-05 | 0 | 1 |
| 2022-06 | 0 | 1.33 |
| 2022-09 | 0 | 1 |
| 2022-10 | 0 | 1 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1.5 |
| 2023-01 | 0 | 2 |
| 2023-02 | 0 | 1 |
| 2023-03 | 0 | 1 |
| 2023-04 | 0 | 2 |
| 2023-05 | 0 | 1.5 |
| 2023-06 | 0 | 1.4 |
| 2023-07 | 0 | 1.8 |
| 2023-08 | 0 | 1.25 |
| 2023-09 | 0 | 1 |
| 2023-10 | 0 | 1.67 |
| 2023-11 | 0 | 1.33 |
| 2023-12 | 0 | 2 |
| 2024-01 | 0 | 1 |
| 2024-02 | 0 | 1 |
| 2024-03 | 0 | 1.14 |
| 2024-04 | 0 | 2 |
| 2024-06 | 0 | 1.25 |
| 2024-07 | 0 | 1 |
| 2024-08 | 0 | 1.67 |
| 2024-09 | 0 | 1.5 |
| 2024-10 | 0 | 1 |
| 2024-11 | 0 | 1 |
| 2024-12 | 0 | 1.25 |
| 2025-01 | 0 | 2.17 |
| 2025-02 | 0 | 2 |
| 2025-03 | 0 | 1.33 |
| 2025-04 | 0 | 2 |
| 2025-05 | 0 | 1 |
| 2025-06 | 0 | 1.75 |
| 2025-07 | 0 | 1.25 |
| 2025-08 | 0 | 1.5 |
| 2025-10 | 0 | 1.17 |
| 2025-11 | 0 | 1.67 |
| 2025-12 | 0 | 2 |
| 2026-01 | 0 | 3 |
| 2026-02 | 0 | 1.44 |
| 2026-03 | 0 | 2 |
| 2026-04 | 0 | 1.5 |
| 2026-05 | 2 | 1.33 |
| 2026-06 | 0 | 1.2 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K143552 — cites (transitively): K103007 (d1), K060988 (d2), K073331 (d2) — cited as predicate by K171858, K173388, K182516, K183194, K192097, K193226, K201391, K203108, K212683, K213615, K220418, K221758, K232265, K240716
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — TORNIER, INC.
- NAI 2015-07-15 Tornier, Inc · 0 citations
- NAI 2015-01-22 Tornier Inc. · 0 citations
- NAI 2014-03-26 Tornier, Inc · 0 citations
- VAI 2013-01-31 Tornier, Inc · 4 citations
- NAI 2011-11-03 Tornier, Inc · 0 citations