Comprehensive SRS
Model 211307 · Biomet Orthopedics, LLC · DI 00880304714830
JDC — Prosthesis, Elbow, Constrained, Cemented · Class II · 21 CFR 888.3150
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
PHX — Shoulder Prosthesis, Reverse Configuration · 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 | 1.81 |
| 2019-02 | 0 | 1.75 |
| 2019-03 | 0 | 1.66 |
| 2019-04 | 0 | 1.93 |
| 2019-05 | 0 | 2.08 |
| 2019-06 | 0 | 1.85 |
| 2019-07 | 0 | 1.67 |
| 2019-08 | 0 | 2.15 |
| 2019-09 | 0 | 1.66 |
| 2019-10 | 0 | 1.89 |
| 2019-11 | 0 | 1.63 |
| 2019-12 | 0 | 1.8 |
| 2020-01 | 0 | 1.9 |
| 2020-02 | 0 | 2.04 |
| 2020-03 | 0 | 2.12 |
| 2020-04 | 0 | 1.69 |
| 2020-05 | 0 | 1.67 |
| 2020-06 | 0 | 2.01 |
| 2020-07 | 0 | 2.19 |
| 2020-08 | 0 | 1.82 |
| 2020-09 | 0 | 2.02 |
| 2020-10 | 0 | 2.23 |
| 2020-11 | 0 | 1.88 |
| 2020-12 | 0 | 1.84 |
| 2021-01 | 0 | 2.1 |
| 2021-02 | 0 | 1.86 |
| 2021-03 | 0 | 2.02 |
| 2021-04 | 0 | 1.96 |
| 2021-05 | 0 | 1.89 |
| 2021-06 | 0 | 1.82 |
| 2021-07 | 0 | 2 |
| 2021-08 | 0 | 2.22 |
| 2021-09 | 0 | 1.91 |
| 2021-10 | 0 | 2.17 |
| 2021-11 | 0 | 2.03 |
| 2021-12 | 0 | 2.43 |
| 2022-01 | 0 | 2.53 |
| 2022-02 | 0 | 2.34 |
| 2022-03 | 0 | 2.4 |
| 2022-04 | 0 | 2.36 |
| 2022-05 | 0 | 2.02 |
| 2022-06 | 0 | 2.25 |
| 2022-07 | 0 | 2.15 |
| 2022-08 | 0 | 2.2 |
| 2022-09 | 0 | 1.98 |
| 2022-10 | 0 | 1.95 |
| 2022-11 | 0 | 2.11 |
| 2022-12 | 0 | 2.01 |
| 2023-01 | 0 | 1.8 |
| 2023-02 | 0 | 1.95 |
| 2023-03 | 0 | 1.94 |
| 2023-04 | 0 | 2.13 |
| 2023-05 | 0 | 2 |
| 2023-06 | 0 | 2.17 |
| 2023-07 | 0 | 2.04 |
| 2023-08 | 0 | 1.71 |
| 2023-09 | 0 | 1.53 |
| 2023-10 | 0 | 1.59 |
| 2023-11 | 0 | 1.66 |
| 2023-12 | 0 | 1.41 |
| 2024-01 | 0 | 1.82 |
| 2024-02 | 0 | 1.9 |
| 2024-03 | 0 | 1.68 |
| 2024-04 | 0 | 1.82 |
| 2024-05 | 0 | 1.68 |
| 2024-06 | 0 | 1.88 |
| 2024-07 | 0 | 1.61 |
| 2024-08 | 0 | 1.69 |
| 2024-09 | 0 | 1.9 |
| 2024-10 | 0 | 1.69 |
| 2024-11 | 0 | 1.62 |
| 2024-12 | 0 | 1.65 |
| 2025-01 | 0 | 1.7 |
| 2025-02 | 0 | 1.63 |
| 2025-03 | 0 | 1.86 |
| 2025-04 | 0 | 1.75 |
| 2025-05 | 0 | 1.87 |
| 2025-06 | 0 | 1.89 |
| 2025-07 | 0 | 1.71 |
| 2025-08 | 0 | 1.65 |
| 2025-09 | 0 | 1.45 |
| 2025-10 | 0 | 1.63 |
| 2025-11 | 0 | 1.72 |
| 2025-12 | 0 | 2.15 |
| 2026-01 | 0 | 1.88 |
| 2026-02 | 0 | 1.73 |
| 2026-03 | 0 | 1.72 |
| 2026-04 | 0 | 1.72 |
| 2026-05 | 0 | 1.7 |
| 2026-06 | 0 | 1.7 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K111746 — cites (transitively): K020045 (d1), K030710 (d1), K033280 (d1), K042321 (d1), K043505 (d1), K622079 (d1), K925613 (d1) — cited as predicate by K143659, K153398, K173411, K223631
K173411 — cites (transitively): K052906 (d1), K060704 (d1), K080642 (d1), K111746 (d1), K112905 (d1), K113069 (d1), K113121 (d1), K120121 (d1), K121543 (d1), K122692 (d1), K130661 (d1), K131353 (d1), K133378 (d1), K143659 (d1), K152754 (d1), K153398 (d1), K020045 (d2), K030710 (d2), K033280 (d2), K042321 (d2), K043505 (d2), K622079 (d2), K925613 (d2), K062998 (d2), K123862 (d2), K001989 (d3) — cited as predicate by K191318, K223631
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC
Nothing in the loaded window.