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TRIALTIS

Model 5161-00-2040 · Medos International Sàrl · DI 10705034589343

OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560

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.

25792019-01: 0 reports for this device; peer average 2.67/device2019-02: 0 reports for this device; peer average 3.61/device2019-03: 0 reports for this device; peer average 3.19/device2019-04: 0 reports for this device; peer average 2.75/device2019-05: 0 reports for this device; peer average 3.1/device2019-06: 0 reports for this device; peer average 2.72/device2019-07: 0 reports for this device; peer average 3.23/device2019-08: 0 reports for this device; peer average 2.93/device2019-09: 0 reports for this device; peer average 2.89/device2019-10: 0 reports for this device; peer average 3.84/device2019-11: 0 reports for this device; peer average 5.54/device2019-12: 0 reports for this device; peer average 3.54/device2020-01: 0 reports for this device; peer average 3.39/device2020-02: 0 reports for this device; peer average 4.56/device2020-03: 0 reports for this device; peer average 4.41/device2020-04: 0 reports for this device; peer average 7.69/device2020-05: 0 reports for this device; peer average 2.37/device2020-06: 0 reports for this device; peer average 3.54/device2020-07: 0 reports for this device; peer average 3.94/device2020-08: 0 reports for this device; peer average 2.61/device2020-09: 0 reports for this device; peer average 3.93/device2020-10: 0 reports for this device; peer average 5.63/device2020-11: 0 reports for this device; peer average 5.77/device2020-12: 0 reports for this device; peer average 4.33/device2021-01: 0 reports for this device; peer average 4.68/device2021-02: 0 reports for this device; peer average 4.08/device2021-03: 0 reports for this device; peer average 3.82/device2021-04: 0 reports for this device; peer average 3.82/device2021-05: 0 reports for this device; peer average 4.15/device2021-06: 0 reports for this device; peer average 3.79/device2021-07: 0 reports for this device; peer average 3.25/device2021-08: 0 reports for this device; peer average 2.96/device2021-09: 0 reports for this device; peer average 2.92/device2021-10: 0 reports for this device; peer average 2.27/device2021-11: 0 reports for this device; peer average 4.24/device2021-12: 0 reports for this device; peer average 2.72/device2022-01: 0 reports for this device; peer average 2.54/device2022-02: 0 reports for this device; peer average 3.16/device2022-03: 0 reports for this device; peer average 3.32/device2022-04: 0 reports for this device; peer average 2.45/device2022-05: 0 reports for this device; peer average 3.91/device2022-06: 0 reports for this device; peer average 4.21/device2022-07: 0 reports for this device; peer average 3.33/device2022-08: 0 reports for this device; peer average 2.9/device2022-09: 0 reports for this device; peer average 2.32/device2022-10: 0 reports for this device; peer average 3.76/device2022-11: 0 reports for this device; peer average 3.44/device2022-12: 0 reports for this device; peer average 4.22/device2023-01: 0 reports for this device; peer average 3.18/device2023-02: 0 reports for this device; peer average 3.44/device2023-03: 0 reports for this device; peer average 3.77/device2023-04: 0 reports for this device; peer average 3.26/device2023-05: 0 reports for this device; peer average 3.02/device2023-06: 0 reports for this device; peer average 2.6/device2023-07: 0 reports for this device; peer average 2.69/device2023-08: 0 reports for this device; peer average 2.51/device2023-09: 0 reports for this device; peer average 4.04/device2023-10: 0 reports for this device; peer average 3.21/device2023-11: 0 reports for this device; peer average 9.13/device2023-12: 0 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 3.71/device2024-02: 0 reports for this device; peer average 4.15/device2024-03: 0 reports for this device; peer average 4.4/device2024-04: 0 reports for this device; peer average 3.95/device2024-05: 0 reports for this device; peer average 4.89/device2024-06: 0 reports for this device; peer average 4.54/device2024-07: 0 reports for this device; peer average 3.92/device2024-08: 0 reports for this device; peer average 4.59/device2024-09: 0 reports for this device; peer average 4.53/device2024-10: 0 reports for this device; peer average 6.31/device2024-11: 0 reports for this device; peer average 4.74/device2024-12: 0 reports for this device; peer average 4.01/device2025-01: 0 reports for this device; peer average 8.37/device2025-02: 0 reports for this device; peer average 4.23/device2025-03: 0 reports for this device; peer average 3.59/device2025-04: 0 reports for this device; peer average 4.2/device2025-05: 0 reports for this device; peer average 4.57/device2025-06: 0 reports for this device; peer average 4.14/device2025-07: 0 reports for this device; peer average 4.32/device2025-08: 0 reports for this device; peer average 5.03/device2025-09: 0 reports for this device; peer average 3.85/device2025-10: 0 reports for this device; peer average 3.97/device2025-11: 0 reports for this device; peer average 4.12/device2025-12: 0 reports for this device; peer average 4.59/device2026-01: 0 reports for this device; peer average 4.53/device2026-02: 0 reports for this device; peer average 4.25/device2026-03: 0 reports for this device; peer average 4.08/device2026-04: 0 reports for this device; peer average 3.9/device2026-05: 0 reports for this device; peer average 4.99/device2026-06: 0 reports for this device; peer average 3.99/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.67
2019-0203.61
2019-0303.19
2019-0402.75
2019-0503.1
2019-0602.72
2019-0703.23
2019-0802.93
2019-0902.89
2019-1003.84
2019-1105.54
2019-1203.54
2020-0103.39
2020-0204.56
2020-0304.41
2020-0407.69
2020-0502.37
2020-0603.54
2020-0703.94
2020-0802.61
2020-0903.93
2020-1005.63
2020-1105.77
2020-1204.33
2021-0104.68
2021-0204.08
2021-0303.82
2021-0403.82
2021-0504.15
2021-0603.79
2021-0703.25
2021-0802.96
2021-0902.92
2021-1002.27
2021-1104.24
2021-1202.72
2022-0102.54
2022-0203.16
2022-0303.32
2022-0402.45
2022-0503.91
2022-0604.21
2022-0703.33
2022-0802.9
2022-0902.32
2022-1003.76
2022-1103.44
2022-1204.22
2023-0103.18
2023-0203.44
2023-0303.77
2023-0403.26
2023-0503.02
2023-0602.6
2023-0702.69
2023-0802.51
2023-0904.04
2023-1003.21
2023-1109.13
2023-1204
2024-0103.71
2024-0204.15
2024-0304.4
2024-0403.95
2024-0504.89
2024-0604.54
2024-0703.92
2024-0804.59
2024-0904.53
2024-1006.31
2024-1104.74
2024-1204.01
2025-0108.37
2025-0204.23
2025-0303.59
2025-0404.2
2025-0504.57
2025-0604.14
2025-0704.32
2025-0805.03
2025-0903.85
2025-1003.97
2025-1104.12
2025-1204.59
2026-0104.53
2026-0204.25
2026-0304.08
2026-0403.9
2026-0504.99
2026-0603.99
This device (reports/month)Average device in OLO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K231527 — cites (transitively): K162309 (d1), K170011 (d1), K200791 (d1), K231479 (d1), K050438 (d2), K133444 (d2), K153660 (d2), K111136 (d2), K140454 (d2), K142185 (d2), K160904 (d2), K173338 (d2), K181949 (d2), K160879 (d2), K124004 (d3), K033901 (d3), K070387 (d3), K091994 (d3), K150216 (d3), K992927 (d3), K103490 (d3), K110216 (d3), K121020 (d3), K130877 (d3), K131802 (d3), K111520 (d3), K123270 (d3), K143628 (d3), K163375 (d3), K142838 (d3), K151885 (d3), K955348 (d4), K063741 (d4), K090648 (d4), K101993 (d4), K061113 (d4), K061639 (d4), K063305 (d4), K081475 (d4), K102701 (d4), K111571 (d4), K062254 (d4), K042508 (d4), K132332 (d4), K003780 (d4), K052734 (d4), K070742 (d4), K071942 (d4), K082728 (d4), K090714 (d4), K091365 (d4), K123656 (d4), K123906 (d4), K143471 (d4), K152338 (d4), K162379 (d4), K080313 (d5), K011182 (d5), K073562 (d5), K102249 (d5), K042789 (d5), K080805 (d5), K083071 (d5), K121191 (d5), K041203 (d5), K080828 (d5), K110353 (d5), K123568 (d5), K022015 (d5), K042498 (d5), K052376 (d5), K052402 (d5), K031833 (d5), K102555 (d5), K113174 (d5), K152457 (d5), K062174 (d6), K023555 (d6), K062728 (d6), K142591 (d6), K142847 (d6), K031655 (d7), K042025 (d7), K052187 (d7), K141494 (d7), K091974 (d8), K140276 (d8) — cited as predicate by K233255, K233256

K233255 — cites (transitively): K200791 (d1), K231527 (d1), K111136 (d2), K140454 (d2), K142185 (d2), K160904 (d2), K162309 (d2), K170011 (d2), K173338 (d2), K181949 (d2), K231479 (d2), K124004 (d3), K033901 (d3), K070387 (d3), K091994 (d3), K103490 (d3), K110216 (d3), K121020 (d3), K130877 (d3), K131802 (d3), K050438 (d3), K133444 (d3), K153660 (d3), K111520 (d3), K123270 (d3), K143628 (d3), K163375 (d3), K142838 (d3), K151885 (d3), K160879 (d3), K955348 (d4), K063741 (d4), K090648 (d4), K101993 (d4), K061113 (d4), K061639 (d4), K063305 (d4), K081475 (d4), K102701 (d4), K111571 (d4), K062254 (d4), K042508 (d4), K132332 (d4), K150216 (d4), K992927 (d4), K003780 (d4), K052734 (d4), K070742 (d4), K071942 (d4), K082728 (d4), K090714 (d4), K091365 (d4), K123656 (d4), K123906 (d4), K143471 (d4), K152338 (d4), K162379 (d4), K080313 (d5), K011182 (d5), K073562 (d5), K102249 (d5), K042789 (d5), K080805 (d5), K083071 (d5), K121191 (d5), K041203 (d5), K080828 (d5), K110353 (d5), K123568 (d5), K022015 (d5), K042498 (d5), K052376 (d5), K052402 (d5), K031833 (d5), K102555 (d5), K113174 (d5), K152457 (d5), K062174 (d6), K023555 (d6), K062728 (d6), K142591 (d6), K142847 (d6), K031655 (d7), K042025 (d7), K052187 (d7), K141494 (d7), K091974 (d8), K140276 (d8) — cited as predicate by K241893

K241893 — cites (transitively): K201661 (d1), K221618 (d1), K233254 (d1), K233255 (d1), K122211 (d2), K183605 (d2), K191943 (d2), K110204 (d2), K202320 (d2), K212245 (d2), K212756 (d2), K223108 (d2), K200791 (d2), K231527 (d2), K042721 (d3), K062358 (d3), K083483 (d3), K050438 (d3), K083310 (d3), K133444 (d3), K111136 (d3), K140454 (d3), K142185 (d3), K160904 (d3), K162309 (d3), K170011 (d3), K173338 (d3), K181949 (d3), K213978 (d3), K231479 (d3), K124004 (d4), K033901 (d4), K070387 (d4), K091994 (d4), K103490 (d4), K110216 (d4), K121020 (d4), K130877 (d4), K131802 (d4), K153660 (d4), K111520 (d4), K123270 (d4), K143628 (d4), K163375 (d4), K142838 (d4), K151885 (d4), K122861 (d4), K123359 (d4), K191579 (d4), K160879 (d4), K955348 (d5), K063741 (d5), K090648 (d5), K101993 (d5), K061113 (d5), K061639 (d5), K063305 (d5), K081475 (d5), K102701 (d5), K111571 (d5), K972768 (d5), K070716 (d5), K072879 (d5), K093792 (d5), K102733 (d5), K961074 (d5), K062254 (d5), K042508 (d5), K132332 (d5), K150216 (d5), K992927 (d5), K003780 (d5), K052734 (d5), K070742 (d5), K071942 (d5), K082728 (d5), K090714 (d5), K091365 (d5), K123656 (d5), K123906 (d5), K143471 (d5), K152338 (d5), K162379 (d5), K181885 (d5), K080313 (d6), K043395 (d6), K072073 (d6), K081051 (d6), K011182 (d6), K073562 (d6), K102249 (d6), K042789 (d6), K080805 (d6), K083071 (d6), K121191 (d6), K041203 (d6), K080828 (d6), K110353 (d6), K123568 (d6), K022015 (d6), K042498 (d6), K052376 (d6), K052402 (d6), K031833 (d6), K102555 (d6), K113174 (d6), K152457 (d6), K002931 (d6), K143705 (d6), K062174 (d7), K023555 (d7), K062728 (d7), K142591 (d7), K142847 (d7), K031655 (d8), K042025 (d8), K052187 (d8), K141494 (d8) — cited as predicate by K254157

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

Manufacturer compliance record — Medos International Sàrl

Nothing in the loaded window.