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VA-LCP

Model 04.117.309S · Synthes GmbH · DI 10886982106018

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

HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040

UDILibrary device dossier · generated 2026-09-07 · 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.

12352019-01: 0 reports for this device; peer average 2.04/device2019-02: 0 reports for this device; peer average 1.58/device2019-03: 0 reports for this device; peer average 1.74/device2019-04: 0 reports for this device; peer average 2.29/device2019-05: 0 reports for this device; peer average 1.72/device2019-06: 0 reports for this device; peer average 1.74/device2019-07: 0 reports for this device; peer average 1.9/device2019-08: 0 reports for this device; peer average 1.85/device2019-09: 0 reports for this device; peer average 1.72/device2019-10: 0 reports for this device; peer average 1.62/device2019-11: 0 reports for this device; peer average 1.89/device2019-12: 0 reports for this device; peer average 2.26/device2020-01: 0 reports for this device; peer average 2.4/device2020-02: 0 reports for this device; peer average 1.44/device2020-03: 0 reports for this device; peer average 1.78/device2020-04: 0 reports for this device; peer average 1.9/device2020-05: 0 reports for this device; peer average 1.76/device2020-06: 0 reports for this device; peer average 2.01/device2020-07: 0 reports for this device; peer average 2.34/device2020-08: 0 reports for this device; peer average 2.42/device2020-09: 0 reports for this device; peer average 2.58/device2020-10: 0 reports for this device; peer average 2.09/device2020-11: 0 reports for this device; peer average 2.65/device2020-12: 0 reports for this device; peer average 2.39/device2021-01: 0 reports for this device; peer average 1.82/device2021-02: 0 reports for this device; peer average 2.14/device2021-03: 0 reports for this device; peer average 2.38/device2021-04: 0 reports for this device; peer average 2.76/device2021-05: 0 reports for this device; peer average 2.5/device2021-06: 0 reports for this device; peer average 2.14/device2021-07: 0 reports for this device; peer average 2.29/device2021-08: 0 reports for this device; peer average 1.99/device2021-09: 0 reports for this device; peer average 2.21/device2021-10: 0 reports for this device; peer average 2.05/device2021-11: 0 reports for this device; peer average 2.19/device2021-12: 0 reports for this device; peer average 2.29/device2022-01: 0 reports for this device; peer average 2.92/device2022-02: 0 reports for this device; peer average 2.13/device2022-03: 0 reports for this device; peer average 1.89/device2022-04: 0 reports for this device; peer average 1.98/device2022-05: 0 reports for this device; peer average 2.2/device2022-06: 0 reports for this device; peer average 2.27/device2022-07: 0 reports for this device; peer average 2.21/device2022-08: 0 reports for this device; peer average 2.3/device2022-09: 0 reports for this device; peer average 2.7/device2022-10: 0 reports for this device; peer average 3/device2022-11: 0 reports for this device; peer average 2.97/device2022-12: 0 reports for this device; peer average 4.54/device2023-01: 0 reports for this device; peer average 2.64/device2023-02: 0 reports for this device; peer average 2.75/device2023-03: 0 reports for this device; peer average 3.05/device2023-04: 0 reports for this device; peer average 2.91/device2023-05: 0 reports for this device; peer average 3.6/device2023-06: 0 reports for this device; peer average 2.95/device2023-07: 0 reports for this device; peer average 2.26/device2023-08: 0 reports for this device; peer average 2.19/device2023-09: 0 reports for this device; peer average 2.04/device2023-10: 0 reports for this device; peer average 2.25/device2023-11: 0 reports for this device; peer average 1.92/device2023-12: 0 reports for this device; peer average 2.43/device2024-01: 0 reports for this device; peer average 2.52/device2024-02: 0 reports for this device; peer average 1.78/device2024-03: 0 reports for this device; peer average 2.15/device2024-04: 0 reports for this device; peer average 2.11/device2024-05: 0 reports for this device; peer average 2.17/device2024-06: 0 reports for this device; peer average 2.29/device2024-07: 0 reports for this device; peer average 2.38/device2024-08: 0 reports for this device; peer average 2.18/device2024-09: 0 reports for this device; peer average 1.95/device2024-10: 0 reports for this device; peer average 2.23/device2024-11: 0 reports for this device; peer average 1.91/device2024-12: 0 reports for this device; peer average 2.81/device2025-01: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 2.06/device2025-03: 0 reports for this device; peer average 2.32/device2025-04: 0 reports for this device; peer average 2.29/device2025-05: 0 reports for this device; peer average 2.35/device2025-06: 0 reports for this device; peer average 1.89/device2025-07: 0 reports for this device; peer average 2.12/device2025-08: 0 reports for this device; peer average 2.27/device2025-09: 0 reports for this device; peer average 1.96/device2025-10: 0 reports for this device; peer average 2.29/device2025-11: 0 reports for this device; peer average 1.99/device2025-12: 0 reports for this device; peer average 2.63/device2026-01: 0 reports for this device; peer average 1.93/device2026-02: 0 reports for this device; peer average 2.21/device2026-03: 0 reports for this device; peer average 2.79/device2026-04: 0 reports for this device; peer average 2.18/device2026-05: 0 reports for this device; peer average 2.41/device2026-06: 0 reports for this device; peer average 2.17/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.04
2019-0201.58
2019-0301.74
2019-0402.29
2019-0501.72
2019-0601.74
2019-0701.9
2019-0801.85
2019-0901.72
2019-1001.62
2019-1101.89
2019-1202.26
2020-0102.4
2020-0201.44
2020-0301.78
2020-0401.9
2020-0501.76
2020-0602.01
2020-0702.34
2020-0802.42
2020-0902.58
2020-1002.09
2020-1102.65
2020-1202.39
2021-0101.82
2021-0202.14
2021-0302.38
2021-0402.76
2021-0502.5
2021-0602.14
2021-0702.29
2021-0801.99
2021-0902.21
2021-1002.05
2021-1102.19
2021-1202.29
2022-0102.92
2022-0202.13
2022-0301.89
2022-0401.98
2022-0502.2
2022-0602.27
2022-0702.21
2022-0802.3
2022-0902.7
2022-1003
2022-1102.97
2022-1204.54
2023-0102.64
2023-0202.75
2023-0303.05
2023-0402.91
2023-0503.6
2023-0602.95
2023-0702.26
2023-0802.19
2023-0902.04
2023-1002.25
2023-1101.92
2023-1202.43
2024-0102.52
2024-0201.78
2024-0302.15
2024-0402.11
2024-0502.17
2024-0602.29
2024-0702.38
2024-0802.18
2024-0901.95
2024-1002.23
2024-1101.91
2024-1202.81
2025-0102
2025-0202.06
2025-0302.32
2025-0402.29
2025-0502.35
2025-0601.89
2025-0702.12
2025-0802.27
2025-0901.96
2025-1002.29
2025-1101.99
2025-1202.63
2026-0101.93
2026-0202.21
2026-0302.79
2026-0402.18
2026-0502.41
2026-0602.17
This device (reports/month)Average device in HRS, HWC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K120717 — cites (transitively): K000684 (d1), K033995 (d1), K100776 (d1), K120070 (d1), K061808 (d2), K063049 (d2), K090063 (d2), K090675 (d2) — cited as predicate by K120854, K152289, K171320, K180310, K200367, K230141, K233873, K261145

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