Print-ready dossier — use your browser's print dialog to save as PDF.
Taperloc Complete Primary Femoral
Model 51-103170 · Biomet Orthopedics, LLC · DI 00880304498341
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
KWL — Prosthesis, Hip, Hemi-, Femoral, Metal · Class II · 21 CFR 888.3360
KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390
KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer · Class II · 21 CFR 888.3310
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3360
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
MAY — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish · Class II · 21 CFR 888.3353
MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353
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 (50)
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.
Malfunction: 50
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
2.67
2019-02
0
2.31
2019-03
0
2.61
2019-04
0
2.51
2019-05
0
2.01
2019-06
0
1.7
2019-07
0
1.73
2019-08
0
1.99
2019-09
0
2.13
2019-10
0
2.31
2019-11
0
1.96
2019-12
0
2.21
2020-01
0
2.51
2020-02
0
2.28
2020-03
1
2.87
2020-04
0
2.04
2020-05
0
2.02
2020-06
0
1.88
2020-07
0
2.31
2020-08
0
1.84
2020-09
0
2.26
2020-10
0
2.24
2020-11
0
2.09
2020-12
0
2.14
2021-01
0
2.24
2021-02
0
1.88
2021-03
0
1.89
2021-04
1
1.89
2021-05
0
1.84
2021-06
0
2.28
2021-07
0
2.13
2021-08
0
2.08
2021-09
0
2.2
2021-10
1
2.05
2021-11
0
1.89
2021-12
0
2.1
2022-01
0
1.89
2022-02
0
1.92
2022-03
1
1.97
2022-04
0
1.99
2022-05
1
1.98
2022-06
0
2.04
2022-07
0
1.94
2022-08
0
1.99
2022-09
0
2.02
2022-10
0
1.98
2022-11
0
2.06
2022-12
1
1.97
2023-01
0
2.11
2023-02
1
1.95
2023-03
0
2.13
2023-04
0
2.09
2023-05
0
2.03
2023-06
0
2.08
2023-07
0
2
2023-08
0
1.89
2023-09
0
1.91
2023-10
1
1.59
2023-11
1
1.55
2023-12
0
1.64
2024-01
0
1.68
2024-02
0
1.93
2024-03
0
1.91
2024-04
0
1.69
2024-05
1
2.01
2024-06
1
1.85
2024-07
1
1.67
2024-08
0
1.85
2024-09
0
1.93
2024-10
0
1.73
2024-11
1
1.64
2024-12
1
1.52
2025-01
0
1.79
2025-02
3
1.48
2025-03
2
1.76
2025-04
5
1.77
2025-05
3
1.62
2025-06
2
1.77
2025-07
3
1.78
2025-08
2
1.62
2025-09
0
1.67
2025-10
4
1.68
2025-11
2
1.72
2025-12
0
1.81
2026-01
3
1.89
2026-02
0
1.57
2026-03
2
1.86
2026-04
2
1.79
2026-05
0
1.6
2026-06
3
1.68
This device (reports/month)Average device in JDI, KWL, KWY, KWZ, LPH, LWJ, LZO, MAY, MEH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K101086 — cited as predicate by K110400, K120030, K140674, K163577, K183532, K183684, K200196, K210653
K200196 — cites (transitively): K101086 (d1) — cited as predicate by K210653, K251270
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC