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Lumbar Plate System

Model 1 · Genesys Orthopedics Systems LLC · DI M719GLP1590

KWQ — Appliance, Fixation, Spinal Intervertebral Body · Class II · 21 CFR 888.3060

UDILibrary device dossier · generated 2026-09-16 · 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 (1)

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: 1

12342019-01: 0 reports for this device; peer average 2.12/device2019-02: 0 reports for this device; peer average 1.9/device2019-03: 0 reports for this device; peer average 1.84/device2019-04: 0 reports for this device; peer average 1.84/device2019-05: 0 reports for this device; peer average 1.96/device2019-06: 0 reports for this device; peer average 2.04/device2019-07: 0 reports for this device; peer average 1.75/device2019-08: 0 reports for this device; peer average 2.78/device2019-09: 0 reports for this device; peer average 1.73/device2019-10: 0 reports for this device; peer average 2.06/device2019-11: 0 reports for this device; peer average 2.18/device2019-12: 0 reports for this device; peer average 1.73/device2020-01: 0 reports for this device; peer average 2.71/device2020-02: 0 reports for this device; peer average 2.04/device2020-03: 0 reports for this device; peer average 1.97/device2020-04: 0 reports for this device; peer average 1.68/device2020-05: 0 reports for this device; peer average 2.18/device2020-06: 0 reports for this device; peer average 2.14/device2020-07: 0 reports for this device; peer average 2.04/device2020-08: 0 reports for this device; peer average 1.9/device2020-09: 0 reports for this device; peer average 2.24/device2020-10: 0 reports for this device; peer average 2.51/device2020-11: 0 reports for this device; peer average 2.69/device2020-12: 0 reports for this device; peer average 2.07/device2021-01: 0 reports for this device; peer average 1.76/device2021-02: 0 reports for this device; peer average 1.85/device2021-03: 0 reports for this device; peer average 2.31/device2021-04: 0 reports for this device; peer average 1.96/device2021-05: 0 reports for this device; peer average 1.87/device2021-06: 0 reports for this device; peer average 2.03/device2021-07: 0 reports for this device; peer average 2.25/device2021-08: 0 reports for this device; peer average 2.25/device2021-09: 0 reports for this device; peer average 1.87/device2021-10: 0 reports for this device; peer average 2.7/device2021-11: 0 reports for this device; peer average 2.1/device2021-12: 0 reports for this device; peer average 2.52/device2022-01: 0 reports for this device; peer average 2.3/device2022-02: 1 reports for this device; peer average 2.14/device2022-03: 0 reports for this device; peer average 1.81/device2022-04: 0 reports for this device; peer average 1.75/device2022-05: 0 reports for this device; peer average 1.97/device2022-06: 0 reports for this device; peer average 2.16/device2022-07: 0 reports for this device; peer average 3.4/device2022-08: 0 reports for this device; peer average 2.29/device2022-09: 0 reports for this device; peer average 2.82/device2022-10: 0 reports for this device; peer average 1.62/device2022-11: 0 reports for this device; peer average 2.09/device2022-12: 0 reports for this device; peer average 2.12/device2023-01: 0 reports for this device; peer average 2.03/device2023-02: 0 reports for this device; peer average 2.15/device2023-03: 0 reports for this device; peer average 2.21/device2023-04: 0 reports for this device; peer average 1.78/device2023-05: 0 reports for this device; peer average 1.98/device2023-06: 0 reports for this device; peer average 1.59/device2023-07: 0 reports for this device; peer average 1.94/device2023-08: 0 reports for this device; peer average 1.36/device2023-09: 0 reports for this device; peer average 2.61/device2023-10: 0 reports for this device; peer average 2.39/device2023-11: 0 reports for this device; peer average 2.36/device2023-12: 0 reports for this device; peer average 1.81/device2024-01: 0 reports for this device; peer average 2.36/device2024-02: 0 reports for this device; peer average 2.13/device2024-03: 0 reports for this device; peer average 3.6/device2024-04: 0 reports for this device; peer average 1.66/device2024-05: 0 reports for this device; peer average 3.02/device2024-06: 0 reports for this device; peer average 3.55/device2024-07: 0 reports for this device; peer average 2.16/device2024-08: 0 reports for this device; peer average 1.76/device2024-09: 0 reports for this device; peer average 2.97/device2024-10: 0 reports for this device; peer average 2.23/device2024-11: 0 reports for this device; peer average 1.69/device2024-12: 0 reports for this device; peer average 1.65/device2025-01: 0 reports for this device; peer average 2.26/device2025-02: 0 reports for this device; peer average 2.53/device2025-03: 0 reports for this device; peer average 2.33/device2025-04: 0 reports for this device; peer average 2.2/device2025-05: 0 reports for this device; peer average 2.74/device2025-06: 0 reports for this device; peer average 2.34/device2025-07: 0 reports for this device; peer average 2.03/device2025-08: 0 reports for this device; peer average 2.03/device2025-09: 0 reports for this device; peer average 2.04/device2025-10: 0 reports for this device; peer average 1.93/device2025-11: 0 reports for this device; peer average 1.98/device2025-12: 0 reports for this device; peer average 2.65/device2026-01: 0 reports for this device; peer average 2.69/device2026-02: 0 reports for this device; peer average 2.47/device2026-03: 0 reports for this device; peer average 2.83/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2.46/device2026-06: 0 reports for this device; peer average 4.37/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.12
2019-0201.9
2019-0301.84
2019-0401.84
2019-0501.96
2019-0602.04
2019-0701.75
2019-0802.78
2019-0901.73
2019-1002.06
2019-1102.18
2019-1201.73
2020-0102.71
2020-0202.04
2020-0301.97
2020-0401.68
2020-0502.18
2020-0602.14
2020-0702.04
2020-0801.9
2020-0902.24
2020-1002.51
2020-1102.69
2020-1202.07
2021-0101.76
2021-0201.85
2021-0302.31
2021-0401.96
2021-0501.87
2021-0602.03
2021-0702.25
2021-0802.25
2021-0901.87
2021-1002.7
2021-1102.1
2021-1202.52
2022-0102.3
2022-0212.14
2022-0301.81
2022-0401.75
2022-0501.97
2022-0602.16
2022-0703.4
2022-0802.29
2022-0902.82
2022-1001.62
2022-1102.09
2022-1202.12
2023-0102.03
2023-0202.15
2023-0302.21
2023-0401.78
2023-0501.98
2023-0601.59
2023-0701.94
2023-0801.36
2023-0902.61
2023-1002.39
2023-1102.36
2023-1201.81
2024-0102.36
2024-0202.13
2024-0303.6
2024-0401.66
2024-0503.02
2024-0603.55
2024-0702.16
2024-0801.76
2024-0902.97
2024-1002.23
2024-1101.69
2024-1201.65
2025-0102.26
2025-0202.53
2025-0302.33
2025-0402.2
2025-0502.74
2025-0602.34
2025-0702.03
2025-0802.03
2025-0902.04
2025-1001.93
2025-1101.98
2025-1202.65
2026-0102.69
2026-0202.47
2026-0302.83
2026-0402
2026-0502.46
2026-0604.37
This device (reports/month)Average device in KWQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K173885 — cites (transitively): K020244 (d1), K022791 (d1), K052546 (d1), K091044 (d1), K142699 (d1), K001844 (d2), K062836 (d2), K080429 (d2), K080773 (d2), K091071 (d2), K092659 (d2), K994347 (d2) — cited as predicate by K192678, K231715, K233360

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Genesys Orthopedics Systems LLC

  • NAI 2023-08-10 Genesys Orthopedics Systems, LLC · 0 citations
  • VAI 2017-09-08 Genesys Orthopedics Systems, LLC · 1 citations
  • NAI 2013-06-05 Genesys Orthopedics Systems, LLC · 0 citations
  • OAI 2012-04-02 Genesys Orthopedics Systems, LLC · 5 citations