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TELIGEN

Model 286006061S · DEPUY SPINE, LLC · DI 10705034604510

HRX — Arthroscope · Class II · 21 CFR 888.1100

UDILibrary device dossier · generated 2026-09-13 · 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 (4)

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.

Injury: 2 · Malfunction: 2

3710132019-01: 0 reports for this device; peer average 13.41/device2019-02: 0 reports for this device; peer average 3.29/device2019-03: 0 reports for this device; peer average 3.78/device2019-04: 0 reports for this device; peer average 4.27/device2019-05: 0 reports for this device; peer average 4.18/device2019-06: 0 reports for this device; peer average 3.67/device2019-07: 0 reports for this device; peer average 3.38/device2019-08: 0 reports for this device; peer average 3.9/device2019-09: 0 reports for this device; peer average 4.55/device2019-10: 0 reports for this device; peer average 5.02/device2019-11: 0 reports for this device; peer average 4.63/device2019-12: 0 reports for this device; peer average 5.21/device2020-01: 0 reports for this device; peer average 5.18/device2020-02: 0 reports for this device; peer average 5.84/device2020-03: 0 reports for this device; peer average 5.61/device2020-04: 0 reports for this device; peer average 5/device2020-05: 0 reports for this device; peer average 3.51/device2020-06: 0 reports for this device; peer average 5.69/device2020-07: 0 reports for this device; peer average 6.15/device2020-08: 0 reports for this device; peer average 5.71/device2020-09: 0 reports for this device; peer average 7.49/device2020-10: 0 reports for this device; peer average 8.72/device2020-11: 0 reports for this device; peer average 5.95/device2020-12: 0 reports for this device; peer average 8.86/device2021-01: 0 reports for this device; peer average 6.31/device2021-02: 0 reports for this device; peer average 5.77/device2021-03: 0 reports for this device; peer average 7.8/device2021-04: 0 reports for this device; peer average 6.1/device2021-05: 0 reports for this device; peer average 5.63/device2021-06: 0 reports for this device; peer average 5.7/device2021-07: 0 reports for this device; peer average 4.96/device2021-08: 0 reports for this device; peer average 5.25/device2021-09: 0 reports for this device; peer average 3.47/device2021-10: 0 reports for this device; peer average 5.1/device2021-11: 0 reports for this device; peer average 3.78/device2021-12: 0 reports for this device; peer average 5.41/device2022-01: 0 reports for this device; peer average 4.97/device2022-02: 0 reports for this device; peer average 3.74/device2022-03: 0 reports for this device; peer average 4.39/device2022-04: 0 reports for this device; peer average 4.17/device2022-05: 0 reports for this device; peer average 4.13/device2022-06: 0 reports for this device; peer average 4.35/device2022-07: 0 reports for this device; peer average 4.38/device2022-08: 0 reports for this device; peer average 4.33/device2022-09: 0 reports for this device; peer average 4.16/device2022-10: 0 reports for this device; peer average 4.1/device2022-11: 0 reports for this device; peer average 4.7/device2022-12: 0 reports for this device; peer average 4.67/device2023-01: 0 reports for this device; peer average 5.09/device2023-02: 0 reports for this device; peer average 4.36/device2023-03: 0 reports for this device; peer average 5.24/device2023-04: 0 reports for this device; peer average 4.82/device2023-05: 0 reports for this device; peer average 4.84/device2023-06: 0 reports for this device; peer average 4.5/device2023-07: 0 reports for this device; peer average 4.29/device2023-08: 0 reports for this device; peer average 5.05/device2023-09: 0 reports for this device; peer average 4.83/device2023-10: 0 reports for this device; peer average 4.41/device2023-11: 0 reports for this device; peer average 7.93/device2023-12: 0 reports for this device; peer average 8.8/device2024-01: 0 reports for this device; peer average 6.2/device2024-02: 0 reports for this device; peer average 6.57/device2024-03: 0 reports for this device; peer average 5.26/device2024-04: 0 reports for this device; peer average 5.97/device2024-05: 0 reports for this device; peer average 8.82/device2024-06: 0 reports for this device; peer average 8.82/device2024-07: 0 reports for this device; peer average 4.91/device2024-08: 0 reports for this device; peer average 4.86/device2024-09: 0 reports for this device; peer average 4.76/device2024-10: 0 reports for this device; peer average 6.15/device2024-11: 0 reports for this device; peer average 5.22/device2024-12: 0 reports for this device; peer average 7.58/device2025-01: 0 reports for this device; peer average 8.91/device2025-02: 0 reports for this device; peer average 6.11/device2025-03: 0 reports for this device; peer average 5.08/device2025-04: 0 reports for this device; peer average 5.43/device2025-05: 0 reports for this device; peer average 5.98/device2025-06: 0 reports for this device; peer average 5.09/device2025-07: 0 reports for this device; peer average 5.28/device2025-08: 0 reports for this device; peer average 4.37/device2025-09: 0 reports for this device; peer average 4.58/device2025-10: 0 reports for this device; peer average 5.09/device2025-11: 0 reports for this device; peer average 5.68/device2025-12: 0 reports for this device; peer average 5.94/device2026-01: 2 reports for this device; peer average 5.53/device2026-02: 2 reports for this device; peer average 5.56/device2026-03: 0 reports for this device; peer average 5.59/device2026-04: 0 reports for this device; peer average 7/device2026-05: 0 reports for this device; peer average 4.7/device2026-06: 0 reports for this device; peer average 4.85/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-01013.41
2019-0203.29
2019-0303.78
2019-0404.27
2019-0504.18
2019-0603.67
2019-0703.38
2019-0803.9
2019-0904.55
2019-1005.02
2019-1104.63
2019-1205.21
2020-0105.18
2020-0205.84
2020-0305.61
2020-0405
2020-0503.51
2020-0605.69
2020-0706.15
2020-0805.71
2020-0907.49
2020-1008.72
2020-1105.95
2020-1208.86
2021-0106.31
2021-0205.77
2021-0307.8
2021-0406.1
2021-0505.63
2021-0605.7
2021-0704.96
2021-0805.25
2021-0903.47
2021-1005.1
2021-1103.78
2021-1205.41
2022-0104.97
2022-0203.74
2022-0304.39
2022-0404.17
2022-0504.13
2022-0604.35
2022-0704.38
2022-0804.33
2022-0904.16
2022-1004.1
2022-1104.7
2022-1204.67
2023-0105.09
2023-0204.36
2023-0305.24
2023-0404.82
2023-0504.84
2023-0604.5
2023-0704.29
2023-0805.05
2023-0904.83
2023-1004.41
2023-1107.93
2023-1208.8
2024-0106.2
2024-0206.57
2024-0305.26
2024-0405.97
2024-0508.82
2024-0608.82
2024-0704.91
2024-0804.86
2024-0904.76
2024-1006.15
2024-1105.22
2024-1207.58
2025-0108.91
2025-0206.11
2025-0305.08
2025-0405.43
2025-0505.98
2025-0605.09
2025-0705.28
2025-0804.37
2025-0904.58
2025-1005.09
2025-1105.68
2025-1205.94
2026-0125.53
2026-0225.56
2026-0305.59
2026-0407
2026-0504.7
2026-0604.85
This device (reports/month)Average device in HRX (reports/device/month)

Regulatory clearances

  • K213978 SESE 2022-10-18 (k number procode)

Predicate lineage

K213978 — cites (transitively): K122861 (d1), K123359 (d1), K191579 (d1), K972768 (d2), K070716 (d2), K072879 (d2), K093792 (d2), K102733 (d2), K961074 (d2), K181885 (d2), K043395 (d3), K072073 (d3), K081051 (d3), K002931 (d3), K143705 (d3) — cited as predicate by K223108

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

Manufacturer compliance record — DEPUY SPINE, LLC

  • NAI 2019-04-18 DePuy Spine, Inc. · 0 citations
  • NAI 2019-04-18 DePuy Spine, Inc. · 0 citations
  • NAI 2017-06-16 DePuy Spine, Inc. · 0 citations
  • NAI 2017-06-16 DePuy Spine, Inc. · 0 citations
  • NAI 2012-06-11 DePuy Spine, Inc. · 0 citations
  • NAI 2012-06-11 DePuy Spine, Inc. · 0 citations
  • NAI 2012-03-06 Depuy Spine Inc · 0 citations
  • VAI 2012-02-10 DePuy Spine, Inc. · 2 citations
  • VAI 2012-02-10 DePuy Spine, Inc. · 2 citations