COMPREHENSIVE SHOULDER SYSTEM
Model 31-406954 · Biomet Orthopedics, LLC · DI 00880304539730
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 2026-09-07 · 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 | 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 | 0 | 1.33 |
| 2026-06 | 0 | 1.2 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K182516 — cites (transitively): K060692 (d1), K143552 (d1), K171858 (d1), K173388 (d1), K103007 (d2), K982981 (d2), K042021 (d2), K102975 (d2), K131298 (d2), K140063 (d2), K153595 (d2), K070479 (d3), K060988 (d3), K073331 (d3), K023096 (d3), K093430 (d3), K143393 (d3), K053340 (d4), K100391 (d4), K123486 (d4), K132624 (d4), K042871 (d5), K052888 (d5), K072160 (d5), K031729 (d5), K040267 (d5), K042883 (d5), K042993 (d5), K051146 (d5), K051380 (d5), K051977 (d5), K053514 (d5), K061521 (d5), K072221 (d5), K072575 (d5), K123166 (d5), K050539 (d6), K063423 (d6), K974556 (d6) — cited as predicate by K203108, K223631, K241873, K250848
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC
Nothing in the loaded window.