Comprehensive Reverse Shoulder
Model TI-115316 · Biomet Orthopedics, LLC · DI 00880304687592
KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660
PAO — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented · Class II · 21 CFR 888.3660
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 | 1.8 |
| 2019-02 | 0 | 1.85 |
| 2019-03 | 0 | 1.75 |
| 2019-04 | 0 | 1.87 |
| 2019-05 | 0 | 2.1 |
| 2019-06 | 0 | 1.89 |
| 2019-07 | 0 | 1.69 |
| 2019-08 | 0 | 2.18 |
| 2019-09 | 0 | 1.68 |
| 2019-10 | 0 | 1.87 |
| 2019-11 | 0 | 1.67 |
| 2019-12 | 0 | 1.75 |
| 2020-01 | 0 | 1.9 |
| 2020-02 | 0 | 2.05 |
| 2020-03 | 0 | 2.16 |
| 2020-04 | 0 | 1.76 |
| 2020-05 | 0 | 1.66 |
| 2020-06 | 0 | 1.91 |
| 2020-07 | 0 | 2.24 |
| 2020-08 | 0 | 1.75 |
| 2020-09 | 0 | 1.94 |
| 2020-10 | 0 | 2.19 |
| 2020-11 | 0 | 1.91 |
| 2020-12 | 0 | 1.87 |
| 2021-01 | 0 | 2.19 |
| 2021-02 | 0 | 1.95 |
| 2021-03 | 0 | 2.12 |
| 2021-04 | 0 | 2.03 |
| 2021-05 | 0 | 1.96 |
| 2021-06 | 0 | 1.9 |
| 2021-07 | 0 | 2.04 |
| 2021-08 | 0 | 2.18 |
| 2021-09 | 0 | 1.92 |
| 2021-10 | 0 | 2.14 |
| 2021-11 | 0 | 2.11 |
| 2021-12 | 0 | 2.56 |
| 2022-01 | 0 | 2.57 |
| 2022-02 | 0 | 2.3 |
| 2022-03 | 0 | 2.4 |
| 2022-04 | 0 | 2.43 |
| 2022-05 | 0 | 2.08 |
| 2022-06 | 0 | 2.19 |
| 2022-07 | 0 | 2.16 |
| 2022-08 | 0 | 2.21 |
| 2022-09 | 0 | 2.02 |
| 2022-10 | 0 | 2.07 |
| 2022-11 | 0 | 2.13 |
| 2022-12 | 0 | 2.05 |
| 2023-01 | 0 | 1.83 |
| 2023-02 | 0 | 1.98 |
| 2023-03 | 0 | 1.97 |
| 2023-04 | 0 | 2.18 |
| 2023-05 | 0 | 2.06 |
| 2023-06 | 0 | 2.24 |
| 2023-07 | 0 | 2.05 |
| 2023-08 | 0 | 1.7 |
| 2023-09 | 0 | 1.56 |
| 2023-10 | 0 | 1.61 |
| 2023-11 | 0 | 1.69 |
| 2023-12 | 0 | 1.44 |
| 2024-01 | 0 | 1.84 |
| 2024-02 | 0 | 1.87 |
| 2024-03 | 0 | 1.69 |
| 2024-04 | 0 | 1.83 |
| 2024-05 | 0 | 1.69 |
| 2024-06 | 0 | 1.84 |
| 2024-07 | 0 | 1.62 |
| 2024-08 | 0 | 1.7 |
| 2024-09 | 0 | 1.68 |
| 2024-10 | 0 | 1.69 |
| 2024-11 | 0 | 1.59 |
| 2024-12 | 0 | 1.62 |
| 2025-01 | 0 | 1.73 |
| 2025-02 | 0 | 1.62 |
| 2025-03 | 0 | 1.89 |
| 2025-04 | 0 | 1.69 |
| 2025-05 | 0 | 1.81 |
| 2025-06 | 0 | 1.92 |
| 2025-07 | 0 | 1.77 |
| 2025-08 | 0 | 1.6 |
| 2025-09 | 0 | 1.49 |
| 2025-10 | 0 | 1.65 |
| 2025-11 | 0 | 1.73 |
| 2025-12 | 0 | 2.21 |
| 2026-01 | 0 | 1.93 |
| 2026-02 | 0 | 1.8 |
| 2026-03 | 0 | 1.78 |
| 2026-04 | 0 | 1.72 |
| 2026-05 | 0 | 1.75 |
| 2026-06 | 0 | 1.76 |
Regulatory clearances
- K131353 SESE 2013-10-08 (k number procode)
Predicate lineage
K080642 — cited as predicate by K162726, K170711, K172456, K172502, K173411, K181611, K193373, K200368, K202024, K210533, K210861, K231445, K233148, K233482, K252404
K131353 — cited as predicate by K172502, K173411, K181611, K193373, K210533
K193373 — cites (transitively): K080642 (d1), K113069 (d1), K113121 (d1), K120121 (d1), K131353 (d1), K132239 (d1), K152754 (d1) — cited as predicate by K212737, K213856, K214001, K233148, K241043, K242253, K243643, K252404, K261683
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC
Nothing in the loaded window.