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PathLoc- SI Joint Fusion System

Model 1025-8070 · L&K BIOMED CO. ,LTD. · DI 08800061394009

OUR — Sacroiliac Joint Fixation · 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.

358102019-01: 0 reports for this device; peer average 2.8/device2019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 2.29/device2019-04: 0 reports for this device; peer average 2.13/device2019-05: 0 reports for this device; peer average 2.08/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2.09/device2019-08: 0 reports for this device; peer average 2.5/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 2.43/device2019-11: 0 reports for this device; peer average 1.86/device2019-12: 0 reports for this device; peer average 1.83/device2020-01: 0 reports for this device; peer average 2.25/device2020-02: 0 reports for this device; peer average 3.14/device2020-03: 0 reports for this device; peer average 1.71/device2020-04: 0 reports for this device; peer average 1.33/device2020-05: 0 reports for this device; peer average 2.5/device2020-06: 0 reports for this device; peer average 2.14/device2020-07: 0 reports for this device; peer average 3/device2020-08: 0 reports for this device; peer average 2.2/device2020-09: 0 reports for this device; peer average 2.75/device2020-10: 0 reports for this device; peer average 2.5/device2020-11: 0 reports for this device; peer average 2.33/device2020-12: 0 reports for this device; peer average 2.22/device2021-01: 0 reports for this device; peer average 1.82/device2021-02: 0 reports for this device; peer average 2.4/device2021-03: 0 reports for this device; peer average 2.6/device2021-04: 0 reports for this device; peer average 1.92/device2021-05: 0 reports for this device; peer average 2.44/device2021-06: 0 reports for this device; peer average 1.8/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 3.75/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1.56/device2021-11: 0 reports for this device; peer average 2.18/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 2/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 3/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 1.75/device2022-08: 0 reports for this device; peer average 3/device2022-12: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 2.67/device2023-06: 0 reports for this device; peer average 3/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 1.86/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 2.33/device2025-02: 0 reports for this device; peer average 4/device2025-03: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1.67/device2025-10: 0 reports for this device; peer average 10/device2025-11: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 2/device010203040506070809101112010203040506070809101112010203040506070809101112010203040507081203040607080203040508091011120102030506070809101101020304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.8
2019-0202
2019-0302.29
2019-0402.13
2019-0502.08
2019-0602
2019-0702.09
2019-0802.5
2019-0902
2019-1002.43
2019-1101.86
2019-1201.83
2020-0102.25
2020-0203.14
2020-0301.71
2020-0401.33
2020-0502.5
2020-0602.14
2020-0703
2020-0802.2
2020-0902.75
2020-1002.5
2020-1102.33
2020-1202.22
2021-0101.82
2021-0202.4
2021-0302.6
2021-0401.92
2021-0502.44
2021-0601.8
2021-0702
2021-0803.75
2021-0902
2021-1001.56
2021-1102.18
2021-1202
2022-0102
2022-0203
2022-0303
2022-0402
2022-0503
2022-0701.75
2022-0803
2022-1203
2023-0303
2023-0402.67
2023-0603
2023-0702
2023-0801
2024-0201.5
2024-0302
2024-0402
2024-0501.67
2024-0801.86
2024-0902
2024-1002
2024-1102
2024-1202
2025-0102.33
2025-0204
2025-0302
2025-0502
2025-0602
2025-0701
2025-0802
2025-0901.67
2025-10010
2025-1102
2026-0102
2026-0201.5
2026-0302
2026-0402
This device (reports/month)Average device in OUR (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K231841 — cites (transitively): K153656 (d1), K181600 (d1), K210035 (d1), K223521 (d1), K021932 (d2), K112240 (d2), K123702 (d2), K141246 (d2), K951389 (d3), K962011 (d3), K962823 (d3), K963172 (d3), K963192 (d3), K092375 (d3), K102907 (d3), K112028 (d3) — cited as predicate by K240201

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

Manufacturer compliance record — L&K BIOMED CO. ,LTD.

  • OAI 2017-01-26 L&K Biomed Co., Ltd. · 0 citations
  • OAI 2017-01-26 L&K Biomed Co., Ltd. · 0 citations
  • VAI 2014-06-05 L&K Biomed Co., Ltd. · 0 citations
  • VAI 2014-06-05 L&K Biomed Co., Ltd. · 0 citations