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Cemented TSI Stem System

Model 111-34-1104 · SIGNATURE ORTHOPAEDICS PTY LTD · DI 09348215054533

LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353

UDILibrary device dossier · generated 2026-09-12 · 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.

12232019-01: 0 reports for this device; peer average 2.72/device2019-02: 0 reports for this device; peer average 2.45/device2019-03: 0 reports for this device; peer average 2.79/device2019-04: 0 reports for this device; peer average 2.65/device2019-05: 0 reports for this device; peer average 2.07/device2019-06: 0 reports for this device; peer average 1.85/device2019-07: 0 reports for this device; peer average 1.73/device2019-08: 0 reports for this device; peer average 2.19/device2019-09: 0 reports for this device; peer average 2.2/device2019-10: 0 reports for this device; peer average 2.5/device2019-11: 0 reports for this device; peer average 2.2/device2019-12: 0 reports for this device; peer average 2.55/device2020-01: 0 reports for this device; peer average 3.08/device2020-02: 0 reports for this device; peer average 2.52/device2020-03: 0 reports for this device; peer average 3.17/device2020-04: 0 reports for this device; peer average 2.37/device2020-05: 0 reports for this device; peer average 2.26/device2020-06: 0 reports for this device; peer average 2.13/device2020-07: 0 reports for this device; peer average 2.62/device2020-08: 0 reports for this device; peer average 2.21/device2020-09: 0 reports for this device; peer average 2.8/device2020-10: 0 reports for this device; peer average 2.76/device2020-11: 0 reports for this device; peer average 2.4/device2020-12: 0 reports for this device; peer average 2.47/device2021-01: 0 reports for this device; peer average 2.52/device2021-02: 0 reports for this device; peer average 2.24/device2021-03: 0 reports for this device; peer average 2.2/device2021-04: 0 reports for this device; peer average 2.17/device2021-05: 0 reports for this device; peer average 2.19/device2021-06: 0 reports for this device; peer average 2.49/device2021-07: 0 reports for this device; peer average 2.58/device2021-08: 0 reports for this device; peer average 2.56/device2021-09: 0 reports for this device; peer average 2.75/device2021-10: 0 reports for this device; peer average 2.46/device2021-11: 0 reports for this device; peer average 2.22/device2021-12: 0 reports for this device; peer average 2.46/device2022-01: 0 reports for this device; peer average 2.31/device2022-02: 0 reports for this device; peer average 2.33/device2022-03: 0 reports for this device; peer average 2.38/device2022-04: 0 reports for this device; peer average 2.3/device2022-05: 0 reports for this device; peer average 2.46/device2022-06: 0 reports for this device; peer average 2.32/device2022-07: 0 reports for this device; peer average 2.32/device2022-08: 0 reports for this device; peer average 2.33/device2022-09: 0 reports for this device; peer average 2.44/device2022-10: 0 reports for this device; peer average 2.4/device2022-11: 0 reports for this device; peer average 2.48/device2022-12: 0 reports for this device; peer average 2.48/device2023-01: 0 reports for this device; peer average 2.63/device2023-02: 0 reports for this device; peer average 2.34/device2023-03: 0 reports for this device; peer average 2.47/device2023-04: 0 reports for this device; peer average 2.44/device2023-05: 0 reports for this device; peer average 2.35/device2023-06: 0 reports for this device; peer average 2.45/device2023-07: 0 reports for this device; peer average 2.31/device2023-08: 0 reports for this device; peer average 2.02/device2023-09: 0 reports for this device; peer average 2.04/device2023-10: 0 reports for this device; peer average 1.8/device2023-11: 0 reports for this device; peer average 1.78/device2023-12: 0 reports for this device; peer average 1.89/device2024-01: 0 reports for this device; peer average 1.84/device2024-02: 0 reports for this device; peer average 2.21/device2024-03: 0 reports for this device; peer average 2.01/device2024-04: 0 reports for this device; peer average 1.91/device2024-05: 0 reports for this device; peer average 2.24/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1.82/device2024-08: 0 reports for this device; peer average 2.05/device2024-09: 0 reports for this device; peer average 2.05/device2024-10: 0 reports for this device; peer average 1.87/device2024-11: 0 reports for this device; peer average 1.99/device2024-12: 0 reports for this device; peer average 1.71/device2025-01: 0 reports for this device; peer average 2.18/device2025-02: 0 reports for this device; peer average 1.66/device2025-03: 0 reports for this device; peer average 1.85/device2025-04: 0 reports for this device; peer average 1.95/device2025-05: 0 reports for this device; peer average 1.94/device2025-06: 0 reports for this device; peer average 1.97/device2025-07: 0 reports for this device; peer average 1.92/device2025-08: 0 reports for this device; peer average 1.94/device2025-09: 0 reports for this device; peer average 1.75/device2025-10: 0 reports for this device; peer average 1.84/device2025-11: 0 reports for this device; peer average 1.9/device2025-12: 0 reports for this device; peer average 1.99/device2026-01: 0 reports for this device; peer average 2.04/device2026-02: 0 reports for this device; peer average 1.83/device2026-03: 0 reports for this device; peer average 1.98/device2026-04: 0 reports for this device; peer average 2.12/device2026-05: 0 reports for this device; peer average 1.92/device2026-06: 0 reports for this device; peer average 1.88/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.72
2019-0202.45
2019-0302.79
2019-0402.65
2019-0502.07
2019-0601.85
2019-0701.73
2019-0802.19
2019-0902.2
2019-1002.5
2019-1102.2
2019-1202.55
2020-0103.08
2020-0202.52
2020-0303.17
2020-0402.37
2020-0502.26
2020-0602.13
2020-0702.62
2020-0802.21
2020-0902.8
2020-1002.76
2020-1102.4
2020-1202.47
2021-0102.52
2021-0202.24
2021-0302.2
2021-0402.17
2021-0502.19
2021-0602.49
2021-0702.58
2021-0802.56
2021-0902.75
2021-1002.46
2021-1102.22
2021-1202.46
2022-0102.31
2022-0202.33
2022-0302.38
2022-0402.3
2022-0502.46
2022-0602.32
2022-0702.32
2022-0802.33
2022-0902.44
2022-1002.4
2022-1102.48
2022-1202.48
2023-0102.63
2023-0202.34
2023-0302.47
2023-0402.44
2023-0502.35
2023-0602.45
2023-0702.31
2023-0802.02
2023-0902.04
2023-1001.8
2023-1101.78
2023-1201.89
2024-0101.84
2024-0202.21
2024-0302.01
2024-0401.91
2024-0502.24
2024-0602
2024-0701.82
2024-0802.05
2024-0902.05
2024-1001.87
2024-1101.99
2024-1201.71
2025-0102.18
2025-0201.66
2025-0301.85
2025-0401.95
2025-0501.94
2025-0601.97
2025-0701.92
2025-0801.94
2025-0901.75
2025-1001.84
2025-1101.9
2025-1201.99
2026-0102.04
2026-0201.83
2026-0301.98
2026-0402.12
2026-0501.92
2026-0601.88
This device (reports/month)Average device in LZO (reports/device/month)

Regulatory clearances

  • K192024 SESE 2020-06-19 (k number procode)

Predicate lineage

K192024 — cites (transitively): K121297 (d1), K133370 (d1), K181340 (d1), K080980 (d2), K093646 (d2), K010367 (d2), K072852 (d2), K091967 (d2), K962101 (d2), K974054 (d2), K980843 (d2), K014072 (d3), K050966 (d3), K072857 (d3), K073337 (d3), K082468 (d3), K082792 (d3), K982447 (d3)

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