Comprehensive® Shoulder System
Model 407315 · Biomet Orthopedics, LLC · DI 00887868505782
HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented · Class II · 21 CFR 888.3690
HWT — Template · Class I · 21 CFR 888.4800
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
MBF — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3670
UDILibrary device dossier · generated 2026-09-13 · 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 | 1.57 |
| 2019-02 | 0 | 1.74 |
| 2019-03 | 0 | 1.65 |
| 2019-04 | 0 | 1.65 |
| 2019-05 | 0 | 2.07 |
| 2019-06 | 0 | 1.63 |
| 2019-07 | 0 | 1.47 |
| 2019-08 | 0 | 1.71 |
| 2019-09 | 0 | 1.52 |
| 2019-10 | 0 | 2.12 |
| 2019-11 | 0 | 1.61 |
| 2019-12 | 0 | 1.79 |
| 2020-01 | 0 | 1.85 |
| 2020-02 | 0 | 1.91 |
| 2020-03 | 0 | 1.64 |
| 2020-04 | 0 | 1.62 |
| 2020-05 | 0 | 1.5 |
| 2020-06 | 0 | 1.86 |
| 2020-07 | 0 | 1.88 |
| 2020-08 | 0 | 1.84 |
| 2020-09 | 0 | 1.9 |
| 2020-10 | 0 | 1.99 |
| 2020-11 | 0 | 1.82 |
| 2020-12 | 0 | 1.74 |
| 2021-01 | 0 | 1.75 |
| 2021-02 | 0 | 1.91 |
| 2021-03 | 0 | 1.93 |
| 2021-04 | 0 | 1.88 |
| 2021-05 | 0 | 1.72 |
| 2021-06 | 0 | 1.74 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 1.96 |
| 2021-09 | 0 | 1.89 |
| 2021-10 | 0 | 1.82 |
| 2021-11 | 0 | 1.83 |
| 2021-12 | 0 | 1.9 |
| 2022-01 | 0 | 1.9 |
| 2022-02 | 0 | 2.06 |
| 2022-03 | 0 | 1.91 |
| 2022-04 | 0 | 1.92 |
| 2022-05 | 0 | 1.7 |
| 2022-06 | 0 | 2.03 |
| 2022-07 | 0 | 2.3 |
| 2022-08 | 0 | 1.85 |
| 2022-09 | 0 | 1.79 |
| 2022-10 | 0 | 2.19 |
| 2022-11 | 0 | 1.79 |
| 2022-12 | 0 | 1.82 |
| 2023-01 | 0 | 1.91 |
| 2023-02 | 0 | 1.86 |
| 2023-03 | 0 | 1.98 |
| 2023-04 | 0 | 1.93 |
| 2023-05 | 0 | 1.89 |
| 2023-06 | 0 | 1.98 |
| 2023-07 | 0 | 1.95 |
| 2023-08 | 0 | 1.63 |
| 2023-09 | 0 | 1.4 |
| 2023-10 | 0 | 1.53 |
| 2023-11 | 0 | 1.79 |
| 2023-12 | 0 | 1.4 |
| 2024-01 | 0 | 1.78 |
| 2024-02 | 0 | 1.83 |
| 2024-03 | 0 | 1.59 |
| 2024-04 | 0 | 1.68 |
| 2024-05 | 0 | 1.65 |
| 2024-06 | 0 | 1.87 |
| 2024-07 | 0 | 1.57 |
| 2024-08 | 0 | 1.62 |
| 2024-09 | 0 | 1.61 |
| 2024-10 | 0 | 1.66 |
| 2024-11 | 0 | 1.62 |
| 2024-12 | 0 | 1.59 |
| 2025-01 | 0 | 1.64 |
| 2025-02 | 0 | 1.53 |
| 2025-03 | 0 | 1.72 |
| 2025-04 | 0 | 1.63 |
| 2025-05 | 0 | 1.75 |
| 2025-06 | 0 | 1.77 |
| 2025-07 | 0 | 1.64 |
| 2025-08 | 0 | 1.56 |
| 2025-09 | 0 | 1.43 |
| 2025-10 | 0 | 1.69 |
| 2025-11 | 0 | 1.94 |
| 2025-12 | 0 | 2.08 |
| 2026-01 | 0 | 1.82 |
| 2026-02 | 0 | 1.77 |
| 2026-03 | 0 | 1.65 |
| 2026-04 | 0 | 1.74 |
| 2026-05 | 0 | 1.63 |
| 2026-06 | 0 | 1.67 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K060692 — cited as predicate by K102924, K120794, K131135, K131633, K162726, K173824, K182516, K183039, K191963, K193038, K202024, K202716, K210899, K212737, K241817
K193038 — cites (transitively): K033506 (d1), K040610 (d1), K060692 (d1), K060694 (d1), K060716 (d1), K140390 (d1), K140652 (d1), K030710 (d2), K915596 (d2) — cited as predicate by K212435, K213856, K214001, K250848
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC
Nothing in the loaded window.