Shoulder Innovations TSA
Model Flat Humeral Sizer, Size 46mm · Shoulder Innovations, Inc. · DI B1132N1HS000460
HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · Class II · 21 CFR 888.3690
KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660
KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650
LXH — Orthopedic Manual Surgical Instrument · Class I · 21 CFR 888.4540
MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3670
UDILibrary device dossier · generated 2026-09-07 · 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 (0)
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 2.12 |
| 2019-02 | 0 | 1.95 |
| 2019-03 | 0 | 1.95 |
| 2019-04 | 0 | 1.87 |
| 2019-05 | 0 | 2.04 |
| 2019-06 | 0 | 2.06 |
| 2019-07 | 0 | 1.88 |
| 2019-08 | 0 | 2.11 |
| 2019-09 | 0 | 2.13 |
| 2019-10 | 0 | 1.94 |
| 2019-11 | 0 | 1.76 |
| 2019-12 | 0 | 1.98 |
| 2020-01 | 0 | 2.11 |
| 2020-02 | 0 | 2.09 |
| 2020-03 | 0 | 1.91 |
| 2020-04 | 0 | 1.88 |
| 2020-05 | 0 | 1.79 |
| 2020-06 | 0 | 2.27 |
| 2020-07 | 0 | 2.72 |
| 2020-08 | 0 | 2.69 |
| 2020-09 | 0 | 2.73 |
| 2020-10 | 0 | 3.08 |
| 2020-11 | 0 | 2.8 |
| 2020-12 | 0 | 2.68 |
| 2021-01 | 0 | 2.82 |
| 2021-02 | 0 | 2.73 |
| 2021-03 | 0 | 2.55 |
| 2021-04 | 0 | 2.65 |
| 2021-05 | 0 | 2.55 |
| 2021-06 | 0 | 2.34 |
| 2021-07 | 0 | 2.32 |
| 2021-08 | 0 | 2.65 |
| 2021-09 | 0 | 2.33 |
| 2021-10 | 0 | 2.27 |
| 2021-11 | 0 | 2.47 |
| 2021-12 | 0 | 2.28 |
| 2022-01 | 0 | 2.39 |
| 2022-02 | 0 | 2.62 |
| 2022-03 | 0 | 2.47 |
| 2022-04 | 0 | 2.66 |
| 2022-05 | 0 | 2.61 |
| 2022-06 | 0 | 2.49 |
| 2022-07 | 0 | 2.33 |
| 2022-08 | 0 | 2.3 |
| 2022-09 | 0 | 2.29 |
| 2022-10 | 0 | 2.34 |
| 2022-11 | 0 | 2.64 |
| 2022-12 | 0 | 2.56 |
| 2023-01 | 0 | 2.91 |
| 2023-02 | 0 | 2.4 |
| 2023-03 | 0 | 2.61 |
| 2023-04 | 0 | 2.38 |
| 2023-05 | 0 | 2.33 |
| 2023-06 | 0 | 2.42 |
| 2023-07 | 0 | 2.31 |
| 2023-08 | 0 | 2.1 |
| 2023-09 | 0 | 1.71 |
| 2023-10 | 0 | 1.82 |
| 2023-11 | 0 | 2.21 |
| 2023-12 | 0 | 1.95 |
| 2024-01 | 0 | 2.18 |
| 2024-02 | 0 | 2.31 |
| 2024-03 | 0 | 1.94 |
| 2024-04 | 0 | 2.39 |
| 2024-05 | 0 | 2.59 |
| 2024-06 | 0 | 2.59 |
| 2024-07 | 0 | 1.99 |
| 2024-08 | 0 | 2.07 |
| 2024-09 | 0 | 2.2 |
| 2024-10 | 0 | 2.06 |
| 2024-11 | 0 | 1.93 |
| 2024-12 | 0 | 1.94 |
| 2025-01 | 0 | 2.08 |
| 2025-02 | 0 | 2.57 |
| 2025-03 | 0 | 2.73 |
| 2025-04 | 0 | 2.05 |
| 2025-05 | 0 | 2.06 |
| 2025-06 | 0 | 2.07 |
| 2025-07 | 0 | 1.87 |
| 2025-08 | 0 | 1.94 |
| 2025-09 | 0 | 1.65 |
| 2025-10 | 0 | 1.74 |
| 2025-11 | 0 | 1.97 |
| 2025-12 | 0 | 2.64 |
| 2026-01 | 0 | 2.21 |
| 2026-02 | 0 | 2.21 |
| 2026-03 | 0 | 2.1 |
| 2026-04 | 0 | 2.12 |
| 2026-05 | 0 | 1.88 |
| 2026-06 | 0 | 2.14 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K102670 — cites (transitively): K982981 (d1) — cited as predicate by K110905, K111596, K192365
K110905 — cites (transitively): K052472 (d1), K102670 (d1), K982981 (d2)
K111596 — cites (transitively): K102670 (d1), K982981 (d1) — cited as predicate by K173824, K192365, K202716, K213615
K173824 — cites (transitively): K060692 (d1), K111596 (d1), K102670 (d2), K982981 (d2) — cited as predicate by K192365, K210533, K213615, K241817, K252221, K252516
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Shoulder Innovations, Inc.
Nothing in the loaded window.