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World hip trial sleeve Size 0
Model 112-42-1000 · SIGNATURE ORTHOPAEDICS PTY LTD · DI 09348215065584
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
MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353
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
2.99
2019-02
0
2.55
2019-03
0
2.96
2019-04
0
2.75
2019-05
0
2.17
2019-06
0
1.79
2019-07
0
1.84
2019-08
0
2.11
2019-09
0
2.42
2019-10
0
2.62
2019-11
0
2.23
2019-12
0
2.46
2020-01
0
2.77
2020-02
0
2.51
2020-03
0
3.17
2020-04
0
2.23
2020-05
0
2.13
2020-06
0
2.06
2020-07
0
2.47
2020-08
0
1.98
2020-09
0
2.5
2020-10
0
2.43
2020-11
0
2.34
2020-12
0
2.28
2021-01
0
2.51
2021-02
0
2
2021-03
0
1.98
2021-04
0
2.06
2021-05
0
1.95
2021-06
0
2.52
2021-07
0
2.23
2021-08
0
2.24
2021-09
0
2.32
2021-10
0
2.15
2021-11
0
1.99
2021-12
0
2.19
2022-01
0
2.02
2022-02
0
1.83
2022-03
0
2.14
2022-04
0
2.05
2022-05
0
2.02
2022-06
0
2.22
2022-07
0
1.99
2022-08
0
2.08
2022-09
0
2.11
2022-10
0
2.06
2022-11
0
2.13
2022-12
0
2.06
2023-01
0
2.14
2023-02
0
2.05
2023-03
0
2.37
2023-04
0
2.24
2023-05
0
2.1
2023-06
0
2.2
2023-07
0
2.04
2023-08
0
1.9
2023-09
0
1.9
2023-10
0
1.64
2023-11
0
1.57
2023-12
0
1.66
2024-01
0
1.69
2024-02
0
2.05
2024-03
0
1.92
2024-04
0
1.72
2024-05
0
1.98
2024-06
0
1.89
2024-07
0
1.7
2024-08
0
1.84
2024-09
0
1.98
2024-10
0
1.79
2024-11
0
1.68
2024-12
0
1.52
2025-01
0
1.86
2025-02
0
1.5
2025-03
0
1.8
2025-04
0
1.77
2025-05
0
1.67
2025-06
0
1.81
2025-07
0
1.81
2025-08
0
1.61
2025-09
0
1.68
2025-10
0
1.64
2025-11
0
1.69
2025-12
0
1.85
2026-01
0
1.9
2026-02
0
1.57
2026-03
0
1.86
2026-04
0
1.82
2026-05
0
1.53
2026-06
0
1.71
This device (reports/month)Average device in KWZ, LPH, MEH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K201278 — cited as predicate by K201047, K241690, K243021, K243162, K252824
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SIGNATURE ORTHOPAEDICS PTY LTD
VAI 2018-07-05 Signature Orthopedics Pty Limited · 3 citations
VAI 2013-06-27 Signature Orthopedics Pty Limited · 1 citations