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"""1.0MM"" SYSTEM"

Model 99-7406 · BIOMET MICROFIXATION, INC · DI 00841036057978

GWO — Plate, Cranioplasty, Preformed, Alterable · Class II · 21 CFR 882.5320

GXR — Cover, Burr Hole · Class II · 21 CFR 882.5250

HBW — Fastener, Plate, Cranioplasty · Class II · 21 CFR 882.5360

JEY — Plate, Bone · Class II · 21 CFR 872.4760

UDILibrary device dossier · generated 2026-09-06 · 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.

23562019-01: 0 reports for this device; peer average 1.45/device2019-02: 0 reports for this device; peer average 1.29/device2019-03: 0 reports for this device; peer average 2.52/device2019-04: 0 reports for this device; peer average 2.48/device2019-05: 0 reports for this device; peer average 3.1/device2019-06: 0 reports for this device; peer average 1.41/device2019-07: 0 reports for this device; peer average 1.73/device2019-08: 0 reports for this device; peer average 2.07/device2019-09: 0 reports for this device; peer average 1.88/device2019-10: 0 reports for this device; peer average 2.5/device2019-11: 0 reports for this device; peer average 1.8/device2019-12: 0 reports for this device; peer average 3.54/device2020-01: 0 reports for this device; peer average 2.47/device2020-02: 0 reports for this device; peer average 1.77/device2020-03: 0 reports for this device; peer average 2.43/device2020-04: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 2.39/device2020-06: 0 reports for this device; peer average 2.41/device2020-07: 0 reports for this device; peer average 2.5/device2020-08: 0 reports for this device; peer average 2.1/device2020-09: 0 reports for this device; peer average 2.66/device2020-10: 0 reports for this device; peer average 2.16/device2020-11: 0 reports for this device; peer average 1.89/device2020-12: 0 reports for this device; peer average 2.24/device2021-01: 0 reports for this device; peer average 2/device2021-02: 0 reports for this device; peer average 1.42/device2021-03: 0 reports for this device; peer average 2.28/device2021-04: 0 reports for this device; peer average 3.92/device2021-05: 0 reports for this device; peer average 2.95/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1.24/device2021-08: 0 reports for this device; peer average 2.9/device2021-09: 0 reports for this device; peer average 1.68/device2021-10: 0 reports for this device; peer average 2.26/device2021-11: 0 reports for this device; peer average 1.77/device2021-12: 0 reports for this device; peer average 2.74/device2022-01: 0 reports for this device; peer average 2.32/device2022-02: 0 reports for this device; peer average 3.69/device2022-03: 0 reports for this device; peer average 3.84/device2022-04: 0 reports for this device; peer average 1.74/device2022-05: 0 reports for this device; peer average 1.64/device2022-06: 0 reports for this device; peer average 3.46/device2022-07: 0 reports for this device; peer average 2.04/device2022-08: 0 reports for this device; peer average 2.03/device2022-09: 0 reports for this device; peer average 1.47/device2022-10: 0 reports for this device; peer average 5.85/device2022-11: 0 reports for this device; peer average 2.33/device2022-12: 0 reports for this device; peer average 3.66/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 3.04/device2023-03: 0 reports for this device; peer average 3.46/device2023-04: 0 reports for this device; peer average 5.06/device2023-05: 0 reports for this device; peer average 2.21/device2023-06: 0 reports for this device; peer average 6.03/device2023-07: 0 reports for this device; peer average 2.76/device2023-08: 0 reports for this device; peer average 2.57/device2023-09: 0 reports for this device; peer average 2.43/device2023-10: 0 reports for this device; peer average 2.11/device2023-11: 0 reports for this device; peer average 2.64/device2023-12: 0 reports for this device; peer average 1.79/device2024-01: 0 reports for this device; peer average 3.53/device2024-02: 0 reports for this device; peer average 2.68/device2024-03: 0 reports for this device; peer average 2.32/device2024-04: 0 reports for this device; peer average 2.81/device2024-05: 0 reports for this device; peer average 2.1/device2024-06: 0 reports for this device; peer average 1.77/device2024-07: 0 reports for this device; peer average 1.35/device2024-08: 0 reports for this device; peer average 1.42/device2024-09: 0 reports for this device; peer average 2.5/device2024-10: 0 reports for this device; peer average 3.23/device2024-11: 0 reports for this device; peer average 3.13/device2024-12: 0 reports for this device; peer average 1.59/device2025-01: 0 reports for this device; peer average 1.64/device2025-02: 0 reports for this device; peer average 1.27/device2025-03: 0 reports for this device; peer average 1.93/device2025-04: 0 reports for this device; peer average 1.88/device2025-05: 0 reports for this device; peer average 2.48/device2025-06: 0 reports for this device; peer average 2.11/device2025-07: 0 reports for this device; peer average 4.1/device2025-08: 0 reports for this device; peer average 2.33/device2025-09: 0 reports for this device; peer average 1.55/device2025-10: 0 reports for this device; peer average 1.73/device2025-11: 0 reports for this device; peer average 1.35/device2025-12: 0 reports for this device; peer average 4.25/device2026-01: 0 reports for this device; peer average 1.72/device2026-02: 0 reports for this device; peer average 2.25/device2026-03: 0 reports for this device; peer average 1.43/device2026-04: 0 reports for this device; peer average 4.43/device2026-05: 0 reports for this device; peer average 2.37/device2026-06: 0 reports for this device; peer average 3.87/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.45
2019-0201.29
2019-0302.52
2019-0402.48
2019-0503.1
2019-0601.41
2019-0701.73
2019-0802.07
2019-0901.88
2019-1002.5
2019-1101.8
2019-1203.54
2020-0102.47
2020-0201.77
2020-0302.43
2020-0402
2020-0502.39
2020-0602.41
2020-0702.5
2020-0802.1
2020-0902.66
2020-1002.16
2020-1101.89
2020-1202.24
2021-0102
2021-0201.42
2021-0302.28
2021-0403.92
2021-0502.95
2021-0602
2021-0701.24
2021-0802.9
2021-0901.68
2021-1002.26
2021-1101.77
2021-1202.74
2022-0102.32
2022-0203.69
2022-0303.84
2022-0401.74
2022-0501.64
2022-0603.46
2022-0702.04
2022-0802.03
2022-0901.47
2022-1005.85
2022-1102.33
2022-1203.66
2023-0102.5
2023-0203.04
2023-0303.46
2023-0405.06
2023-0502.21
2023-0606.03
2023-0702.76
2023-0802.57
2023-0902.43
2023-1002.11
2023-1102.64
2023-1201.79
2024-0103.53
2024-0202.68
2024-0302.32
2024-0402.81
2024-0502.1
2024-0601.77
2024-0701.35
2024-0801.42
2024-0902.5
2024-1003.23
2024-1103.13
2024-1201.59
2025-0101.64
2025-0201.27
2025-0301.93
2025-0401.88
2025-0502.48
2025-0602.11
2025-0704.1
2025-0802.33
2025-0901.55
2025-1001.73
2025-1101.35
2025-1204.25
2026-0101.72
2026-0202.25
2026-0301.43
2026-0404.43
2026-0502.37
2026-0603.87
This device (reports/month)Average device in GWO, GXR, HBW, JEY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K121589 — cites (transitively): K854886 (d1), K862534 (d1), K922741 (d1), K953385 (d1) — cited as predicate by K132600, K140037, K180249, K182609

K121624 — cites (transitively): K854886 (d1), K922741 (d1), K953385 (d1) — cited as predicate by K141911, K180249, K212391

K953385 — cited as predicate by K121589, K121624, K122049, K230398, K253373

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

Manufacturer compliance record — BIOMET MICROFIXATION, INC

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