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QUADRANT SPARING HIP SYSTEM
Model 11-105146 · Biomet Orthopedics, LLC · DI 00880304200760
JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350
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
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 2026-09-11 · 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
2.98
2019-02
0
2.5
2019-03
0
2.83
2019-04
0
2.68
2019-05
0
2.13
2019-06
0
1.78
2019-07
0
1.86
2019-08
0
2.05
2019-09
0
2.35
2019-10
0
2.49
2019-11
0
2.08
2019-12
0
2.36
2020-01
0
2.64
2020-02
0
2.45
2020-03
0
3.13
2020-04
0
2.14
2020-05
0
2.15
2020-06
0
1.96
2020-07
0
2.42
2020-08
0
1.89
2020-09
0
2.35
2020-10
0
2.37
2020-11
0
2.22
2020-12
0
2.21
2021-01
0
2.38
2021-02
0
1.94
2021-03
0
1.94
2021-04
0
1.96
2021-05
0
1.91
2021-06
0
2.42
2021-07
0
2.16
2021-08
0
2.1
2021-09
0
2.21
2021-10
0
2.07
2021-11
0
1.97
2021-12
0
2.18
2022-01
0
1.94
2022-02
0
1.95
2022-03
0
2.02
2022-04
0
2.05
2022-05
0
1.95
2022-06
0
2.13
2022-07
0
1.95
2022-08
0
2.02
2022-09
0
2.02
2022-10
0
2
2022-11
0
2.09
2022-12
0
2.01
2023-01
0
1.97
2023-02
0
1.96
2023-03
0
2.22
2023-04
0
2.11
2023-05
0
2.07
2023-06
0
2.12
2023-07
0
2.01
2023-08
0
1.92
2023-09
0
1.91
2023-10
0
1.58
2023-11
0
1.55
2023-12
0
1.63
2024-01
0
1.68
2024-02
0
1.96
2024-03
0
1.91
2024-04
0
1.68
2024-05
0
2
2024-06
0
1.86
2024-07
0
1.68
2024-08
0
1.82
2024-09
0
1.94
2024-10
0
1.72
2024-11
0
1.61
2024-12
0
1.49
2025-01
0
1.76
2025-02
0
1.46
2025-03
0
1.75
2025-04
0
1.75
2025-05
0
1.6
2025-06
0
1.76
2025-07
0
1.76
2025-08
0
1.58
2025-09
0
1.69
2025-10
0
1.66
2025-11
0
1.72
2025-12
0
1.83
2026-01
0
1.91
2026-02
0
1.55
2026-03
0
1.9
2026-04
0
1.77
2026-05
0
1.59
2026-06
0
1.68
This device (reports/month)Average device in JDI, KWZ, LPH, MAY, MEH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K050124 — cited as predicate by K111863
K920640 — cited as predicate by K111863
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC