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TRABECULAR METAL™
Model 00-5452-013-20 · ZIMMER TRABECULAR METAL TECHNOLOGY INC. · DI 00889024308992
FZX — Guide, Surgical, Instrument · Class I · 21 CFR 878.4800
JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560
MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer · Class II · 21 CFR 888.3565
UDILibrary device dossier · generated 2026-09-15 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.87
2019-02
0
1.92
2019-03
0
1.58
2019-04
0
1.87
2019-05
0
1.72
2019-06
0
1.98
2019-07
0
1.89
2019-08
0
2.07
2019-09
0
1.82
2019-10
0
2.19
2019-11
0
2.65
2019-12
0
2.17
2020-01
0
2.18
2020-02
0
2.47
2020-03
0
2.09
2020-04
0
1.99
2020-05
0
1.7
2020-06
0
1.93
2020-07
0
2.46
2020-08
0
2.49
2020-09
0
2.07
2020-10
0
2.61
2020-11
0
2.56
2020-12
0
2.64
2021-01
0
2.24
2021-02
0
2.24
2021-03
0
2.33
2021-04
0
2.26
2021-05
0
2.2
2021-06
0
2.03
2021-07
0
2.01
2021-08
0
1.74
2021-09
0
2.09
2021-10
0
1.8
2021-11
0
2.09
2021-12
0
2.1
2022-01
0
1.83
2022-02
0
2.19
2022-03
0
1.87
2022-04
0
1.88
2022-05
0
2.08
2022-06
0
1.85
2022-07
0
1.93
2022-08
0
1.92
2022-09
0
2.05
2022-10
0
2
2022-11
0
2.08
2022-12
0
1.74
2023-01
0
1.96
2023-02
0
2.06
2023-03
0
2.05
2023-04
0
2.12
2023-05
0
2.24
2023-06
0
2.13
2023-07
0
1.87
2023-08
0
1.58
2023-09
0
1.62
2023-10
0
1.51
2023-11
0
1.58
2023-12
0
1.6
2024-01
0
1.46
2024-02
0
1.67
2024-03
0
1.66
2024-04
0
1.54
2024-05
0
1.74
2024-06
0
1.82
2024-07
0
1.69
2024-08
0
2.14
2024-09
0
1.86
2024-10
0
1.83
2024-11
0
1.79
2024-12
0
1.9
2025-01
0
2.07
2025-02
0
1.68
2025-03
0
1.67
2025-04
0
1.57
2025-05
0
1.59
2025-06
0
1.64
2025-07
0
1.52
2025-08
0
1.59
2025-09
0
1.52
2025-10
0
1.36
2025-11
0
1.58
2025-12
0
1.57
2026-01
0
1.5
2026-02
0
1.48
2026-03
0
1.79
2026-04
0
1.6
2026-05
0
1.59
2026-06
0
1.56
This device (reports/month)Average device in FZX, JWH, MBH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K102896 — cited as predicate by K140883, K141840, K170149, K200113, K200653, K201364