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Unnamed device

Model 402.238 · Synthes GmbH · DI 10886982205889

HRS — Plate, Fixation, Bone · Class II · 21 CFR 888.3030

KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component · Class II · 21 CFR 888.3030

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.

12342019-01: 0 reports for this device; peer average 1.87/device2019-02: 0 reports for this device; peer average 1.55/device2019-03: 0 reports for this device; peer average 1.78/device2019-04: 0 reports for this device; peer average 2.29/device2019-05: 0 reports for this device; peer average 1.63/device2019-06: 0 reports for this device; peer average 1.63/device2019-07: 0 reports for this device; peer average 1.79/device2019-08: 0 reports for this device; peer average 1.55/device2019-09: 0 reports for this device; peer average 1.61/device2019-10: 0 reports for this device; peer average 1.47/device2019-11: 0 reports for this device; peer average 1.68/device2019-12: 0 reports for this device; peer average 1.91/device2020-01: 0 reports for this device; peer average 2.08/device2020-02: 0 reports for this device; peer average 1.33/device2020-03: 0 reports for this device; peer average 1.59/device2020-04: 0 reports for this device; peer average 1.81/device2020-05: 0 reports for this device; peer average 1.66/device2020-06: 0 reports for this device; peer average 1.93/device2020-07: 0 reports for this device; peer average 1.85/device2020-08: 0 reports for this device; peer average 2.3/device2020-09: 0 reports for this device; peer average 2.68/device2020-10: 0 reports for this device; peer average 2.03/device2020-11: 0 reports for this device; peer average 2.17/device2020-12: 0 reports for this device; peer average 2.26/device2021-01: 0 reports for this device; peer average 1.75/device2021-02: 0 reports for this device; peer average 2.08/device2021-03: 0 reports for this device; peer average 2.23/device2021-04: 0 reports for this device; peer average 2.74/device2021-05: 0 reports for this device; peer average 2.69/device2021-06: 0 reports for this device; peer average 2.02/device2021-07: 0 reports for this device; peer average 2.13/device2021-08: 0 reports for this device; peer average 1.81/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1.88/device2021-11: 0 reports for this device; peer average 2.26/device2021-12: 0 reports for this device; peer average 2.1/device2022-01: 0 reports for this device; peer average 2.68/device2022-02: 0 reports for this device; peer average 2.24/device2022-03: 0 reports for this device; peer average 1.76/device2022-04: 0 reports for this device; peer average 2.1/device2022-05: 0 reports for this device; peer average 2.24/device2022-06: 0 reports for this device; peer average 2.34/device2022-07: 0 reports for this device; peer average 2.23/device2022-08: 0 reports for this device; peer average 2.03/device2022-09: 0 reports for this device; peer average 2.42/device2022-10: 0 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 3.07/device2022-12: 0 reports for this device; peer average 2.74/device2023-01: 0 reports for this device; peer average 2.59/device2023-02: 0 reports for this device; peer average 2.47/device2023-03: 0 reports for this device; peer average 2.78/device2023-04: 0 reports for this device; peer average 2.95/device2023-05: 0 reports for this device; peer average 3.91/device2023-06: 0 reports for this device; peer average 2.83/device2023-07: 0 reports for this device; peer average 2.21/device2023-08: 0 reports for this device; peer average 2.04/device2023-09: 0 reports for this device; peer average 2.12/device2023-10: 0 reports for this device; peer average 2.29/device2023-11: 0 reports for this device; peer average 1.92/device2023-12: 0 reports for this device; peer average 2.24/device2024-01: 0 reports for this device; peer average 1.95/device2024-02: 0 reports for this device; peer average 1.77/device2024-03: 0 reports for this device; peer average 1.73/device2024-04: 0 reports for this device; peer average 2.08/device2024-05: 0 reports for this device; peer average 1.85/device2024-06: 0 reports for this device; peer average 2.24/device2024-07: 0 reports for this device; peer average 2.07/device2024-08: 0 reports for this device; peer average 2.15/device2024-09: 0 reports for this device; peer average 1.6/device2024-10: 0 reports for this device; peer average 2.28/device2024-11: 0 reports for this device; peer average 1.62/device2024-12: 0 reports for this device; peer average 2.96/device2025-01: 0 reports for this device; peer average 1.58/device2025-02: 0 reports for this device; peer average 1.73/device2025-03: 0 reports for this device; peer average 2.55/device2025-04: 0 reports for this device; peer average 1.84/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1.65/device2025-07: 0 reports for this device; peer average 2.05/device2025-08: 0 reports for this device; peer average 1.95/device2025-09: 0 reports for this device; peer average 1.71/device2025-10: 0 reports for this device; peer average 2.17/device2025-11: 0 reports for this device; peer average 1.91/device2025-12: 0 reports for this device; peer average 2.32/device2026-01: 0 reports for this device; peer average 1.67/device2026-02: 0 reports for this device; peer average 1.92/device2026-03: 0 reports for this device; peer average 2.8/device2026-04: 0 reports for this device; peer average 2.18/device2026-05: 0 reports for this device; peer average 2.2/device2026-06: 0 reports for this device; peer average 1.79/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.87
2019-0201.55
2019-0301.78
2019-0402.29
2019-0501.63
2019-0601.63
2019-0701.79
2019-0801.55
2019-0901.61
2019-1001.47
2019-1101.68
2019-1201.91
2020-0102.08
2020-0201.33
2020-0301.59
2020-0401.81
2020-0501.66
2020-0601.93
2020-0701.85
2020-0802.3
2020-0902.68
2020-1002.03
2020-1102.17
2020-1202.26
2021-0101.75
2021-0202.08
2021-0302.23
2021-0402.74
2021-0502.69
2021-0602.02
2021-0702.13
2021-0801.81
2021-0902
2021-1001.88
2021-1102.26
2021-1202.1
2022-0102.68
2022-0202.24
2022-0301.76
2022-0402.1
2022-0502.24
2022-0602.34
2022-0702.23
2022-0802.03
2022-0902.42
2022-1003
2022-1103.07
2022-1202.74
2023-0102.59
2023-0202.47
2023-0302.78
2023-0402.95
2023-0503.91
2023-0602.83
2023-0702.21
2023-0802.04
2023-0902.12
2023-1002.29
2023-1101.92
2023-1202.24
2024-0101.95
2024-0201.77
2024-0301.73
2024-0402.08
2024-0501.85
2024-0602.24
2024-0702.07
2024-0802.15
2024-0901.6
2024-1002.28
2024-1101.62
2024-1202.96
2025-0101.58
2025-0201.73
2025-0302.55
2025-0401.84
2025-0502
2025-0601.65
2025-0702.05
2025-0801.95
2025-0901.71
2025-1002.17
2025-1101.91
2025-1202.32
2026-0101.67
2026-0201.92
2026-0302.8
2026-0402.18
2026-0502.2
2026-0601.79
This device (reports/month)Average device in HRS, KTT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K033995 — cited as predicate by K112560, K113733, K120717, K132787, K141677, K141680, K150561, K153374, K153716, K161696, K163383, K180310, K191793, K192619, K200367, K213108, K222282, K232394, K233873

K050110 — cited as predicate by K111253, K153374, K190391, K190750, K190992, K200575

K063049 — cited as predicate by K100776, K103332, K110086, K111253, K113364, K121601, K122334, K123000, K132886, K133536, K140724, K142419, K143394, K150099, K160553, K163046, K163361, K171904, K180554, K182201, K190391, K190750, K190992, K191344, K191412, K201510, K201656, K211051, K212581, K221920, K223150, K232394, K233665, K242973, K252191, K254054

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

Manufacturer compliance record — Synthes GmbH

  • Warning Letter 2012-02-16 Synthes, Inc.
  • NAI 2017-08-08 Synthes GmbH · 0 citations
  • NAI 2017-01-18 Synthes (USA), LLC · 0 citations
  • VAI 2015-05-08 Synthes (USA), LLC · 2 citations
  • VAI 2013-11-13 Synthes, Inc. · 1 citations
  • NAI 2013-05-16 Synthes, Inc. · 0 citations
  • VAI 2012-10-19 Synthes, Inc. · 1 citations
  • NAI 2012-02-01 Synthes (USA), LLC · 0 citations
  • OAI 2011-09-15 Synthes, Inc. · 10 citations