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SMARTLOCK

Model 55-02950 · Stryker Leibinger GmbH & Co. KG · DI 34546540732072

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

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.

23572019-01: 0 reports for this device; peer average 1.41/device2019-02: 0 reports for this device; peer average 1.33/device2019-03: 0 reports for this device; peer average 2.41/device2019-04: 0 reports for this device; peer average 2.95/device2019-05: 0 reports for this device; peer average 3.31/device2019-06: 0 reports for this device; peer average 1.41/device2019-07: 0 reports for this device; peer average 1.76/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 2.17/device2019-10: 0 reports for this device; peer average 2.53/device2019-11: 0 reports for this device; peer average 1.72/device2019-12: 0 reports for this device; peer average 2.35/device2020-01: 0 reports for this device; peer average 2.54/device2020-02: 0 reports for this device; peer average 1.83/device2020-03: 0 reports for this device; peer average 2.06/device2020-04: 0 reports for this device; peer average 2.13/device2020-05: 0 reports for this device; peer average 2.31/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2.17/device2020-08: 0 reports for this device; peer average 2.21/device2020-09: 0 reports for this device; peer average 2.06/device2020-10: 0 reports for this device; peer average 2.22/device2020-11: 0 reports for this device; peer average 1.71/device2020-12: 0 reports for this device; peer average 1.9/device2021-01: 0 reports for this device; peer average 2.13/device2021-02: 0 reports for this device; peer average 1.25/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 3.33/device2021-05: 0 reports for this device; peer average 4.09/device2021-06: 0 reports for this device; peer average 1.93/device2021-07: 0 reports for this device; peer average 1.33/device2021-08: 0 reports for this device; peer average 3.31/device2021-09: 0 reports for this device; peer average 1.58/device2021-10: 0 reports for this device; peer average 2.12/device2021-11: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 3.93/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 2.67/device2022-03: 0 reports for this device; peer average 3.5/device2022-04: 0 reports for this device; peer average 2.36/device2022-05: 0 reports for this device; peer average 1.77/device2022-06: 0 reports for this device; peer average 2.5/device2022-07: 0 reports for this device; peer average 2.16/device2022-08: 0 reports for this device; peer average 2.15/device2022-09: 0 reports for this device; peer average 1.5/device2022-10: 0 reports for this device; peer average 6.64/device2022-11: 0 reports for this device; peer average 2.27/device2022-12: 0 reports for this device; peer average 3.37/device2023-01: 0 reports for this device; peer average 2.67/device2023-02: 0 reports for this device; peer average 3.26/device2023-03: 0 reports for this device; peer average 2.67/device2023-04: 0 reports for this device; peer average 1.5/device2023-05: 0 reports for this device; peer average 2.88/device2023-06: 0 reports for this device; peer average 4.15/device2023-07: 0 reports for this device; peer average 3.81/device2023-08: 0 reports for this device; peer average 3.07/device2023-09: 0 reports for this device; peer average 2.58/device2023-10: 0 reports for this device; peer average 1.44/device2023-11: 0 reports for this device; peer average 2.68/device2023-12: 0 reports for this device; peer average 2.05/device2024-01: 0 reports for this device; peer average 2.89/device2024-02: 0 reports for this device; peer average 2.67/device2024-03: 0 reports for this device; peer average 2.23/device2024-04: 0 reports for this device; peer average 2.61/device2024-05: 0 reports for this device; peer average 2.29/device2024-06: 0 reports for this device; peer average 1.83/device2024-07: 0 reports for this device; peer average 1.55/device2024-08: 0 reports for this device; peer average 1.6/device2024-09: 0 reports for this device; peer average 2.07/device2024-10: 0 reports for this device; peer average 2.29/device2024-11: 0 reports for this device; peer average 2.75/device2024-12: 0 reports for this device; peer average 1.7/device2025-01: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1.38/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1.9/device2025-05: 0 reports for this device; peer average 2.27/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 4.1/device2025-08: 0 reports for this device; peer average 2.57/device2025-09: 0 reports for this device; peer average 1.69/device2025-10: 0 reports for this device; peer average 1.95/device2025-11: 0 reports for this device; peer average 1.53/device2025-12: 0 reports for this device; peer average 4.38/device2026-01: 0 reports for this device; peer average 1.57/device2026-02: 0 reports for this device; peer average 2.45/device2026-03: 0 reports for this device; peer average 1.11/device2026-04: 0 reports for this device; peer average 3.09/device2026-05: 0 reports for this device; peer average 2.1/device2026-06: 0 reports for this device; peer average 3.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.41
2019-0201.33
2019-0302.41
2019-0402.95
2019-0503.31
2019-0601.41
2019-0701.76
2019-0802
2019-0902.17
2019-1002.53
2019-1101.72
2019-1202.35
2020-0102.54
2020-0201.83
2020-0302.06
2020-0402.13
2020-0502.31
2020-0602
2020-0702.17
2020-0802.21
2020-0902.06
2020-1002.22
2020-1101.71
2020-1201.9
2021-0102.13
2021-0201.25
2021-0302
2021-0403.33
2021-0504.09
2021-0601.93
2021-0701.33
2021-0803.31
2021-0901.58
2021-1002.12
2021-1102
2021-1203.93
2022-0102
2022-0202.67
2022-0303.5
2022-0402.36
2022-0501.77
2022-0602.5
2022-0702.16
2022-0802.15
2022-0901.5
2022-1006.64
2022-1102.27
2022-1203.37
2023-0102.67
2023-0203.26
2023-0302.67
2023-0401.5
2023-0502.88
2023-0604.15
2023-0703.81
2023-0803.07
2023-0902.58
2023-1001.44
2023-1102.68
2023-1202.05
2024-0102.89
2024-0202.67
2024-0302.23
2024-0402.61
2024-0502.29
2024-0601.83
2024-0701.55
2024-0801.6
2024-0902.07
2024-1002.29
2024-1102.75
2024-1201.7
2025-0101.5
2025-0201.38
2025-0302
2025-0401.9
2025-0502.27
2025-0602
2025-0704.1
2025-0802.57
2025-0901.69
2025-1001.95
2025-1101.53
2025-1204.38
2026-0101.57
2026-0202.45
2026-0301.11
2026-0403.09
2026-0502.1
2026-0603.56
This device (reports/month)Average device in JEY (reports/device/month)

Regulatory clearances

  • K122313 SESE 2012-10-31 (k number procode)

Predicate lineage

K122313 — cites (transitively): K050535 (d1), K061271 (d1) — cited as predicate by K141165, K143336, K173320, K231599, K240651, K252246

K240651 — cites (transitively): K050535 (d1), K122313 (d1), K133461 (d1), K171364 (d1), K172572 (d1), K221855 (d1), K231599 (d1), K980364 (d1), K061271 (d2), K123786 (d2), K014263 (d2), K022185 (d2), K031659 (d2), K080331 (d3)

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

Manufacturer compliance record — Stryker Leibinger GmbH & Co. KG

  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2017-07-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2013-11-14 Stryker Leibinger GmbH & Co. KG · 0 citations