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Aries-L Lateral Lumbar Interbody System

Model 1450-8114 · Osseus Fusion Systems, LLC · DI B06214508114

HWM — Osteotome · Class I · 21 CFR 878.4800

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 (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.

13452019-01: 0 reports for this device; peer average 1.25/device2019-02: 0 reports for this device; peer average 1.33/device2019-03: 0 reports for this device; peer average 1.2/device2019-04: 0 reports for this device; peer average 1.2/device2019-05: 0 reports for this device; peer average 1.5/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1.14/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 3/device2019-11: 0 reports for this device; peer average 1.75/device2019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 3.5/device2020-02: 0 reports for this device; peer average 1.25/device2020-03: 0 reports for this device; peer average 2.5/device2020-04: 0 reports for this device; peer average 1.43/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1.5/device2020-11: 0 reports for this device; peer average 2.33/device2020-12: 0 reports for this device; peer average 2.33/device2021-01: 0 reports for this device; peer average 1.2/device2021-02: 0 reports for this device; peer average 2.5/device2021-03: 0 reports for this device; peer average 2.17/device2021-04: 0 reports for this device; peer average 2.75/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 2.33/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1.89/device2021-10: 0 reports for this device; peer average 2.5/device2021-11: 0 reports for this device; peer average 2.2/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 5/device2022-02: 0 reports for this device; peer average 1.67/device2022-03: 0 reports for this device; peer average 2.25/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 2/device2022-08: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 2.75/device2022-12: 0 reports for this device; peer average 1.5/device2023-01: 0 reports for this device; peer average 1.67/device2023-03: 0 reports for this device; peer average 2.38/device2023-04: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 1.5/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1.5/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 2.86/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1.33/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 1.5/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1.45/device2024-07: 0 reports for this device; peer average 1.6/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1.8/device2024-10: 0 reports for this device; peer average 1.71/device2024-11: 0 reports for this device; peer average 1.5/device2024-12: 0 reports for this device; peer average 1.63/device2025-01: 0 reports for this device; peer average 2.83/device2025-02: 0 reports for this device; peer average 2.33/device2025-03: 0 reports for this device; peer average 2.33/device2025-04: 0 reports for this device; peer average 2.2/device2025-05: 0 reports for this device; peer average 1.55/device2025-06: 0 reports for this device; peer average 2.29/device2025-07: 0 reports for this device; peer average 1.57/device2025-08: 0 reports for this device; peer average 1.33/device2025-09: 0 reports for this device; peer average 3.6/device2025-10: 0 reports for this device; peer average 1.71/device2025-11: 0 reports for this device; peer average 2.4/device2025-12: 0 reports for this device; peer average 2.6/device2026-01: 0 reports for this device; peer average 2.25/device2026-02: 0 reports for this device; peer average 1.45/device2026-03: 0 reports for this device; peer average 2.5/device2026-04: 0 reports for this device; peer average 1.67/device2026-05: 0 reports for this device; peer average 1.83/device2026-06: 0 reports for this device; peer average 2.71/device01020304050607080910111201020304050607080910111201020304050607080910111201020304050608091011120103040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.25
2019-0201.33
2019-0301.2
2019-0401.2
2019-0501.5
2019-0602
2019-0701
2019-0801.14
2019-0901
2019-1003
2019-1101.75
2019-1201
2020-0103.5
2020-0201.25
2020-0302.5
2020-0401.43
2020-0501
2020-0602
2020-0701
2020-0801
2020-0901
2020-1001.5
2020-1102.33
2020-1202.33
2021-0101.2
2021-0202.5
2021-0302.17
2021-0402.75
2021-0502
2021-0601
2021-0702.33
2021-0802
2021-0901.89
2021-1002.5
2021-1102.2
2021-1201
2022-0105
2022-0201.67
2022-0302.25
2022-0401
2022-0501
2022-0602
2022-0803
2022-0901
2022-1001
2022-1102.75
2022-1201.5
2023-0101.67
2023-0302.38
2023-0402
2023-0502
2023-0601.5
2023-0701
2023-0801
2023-0901.5
2023-1001
2023-1102.86
2023-1201
2024-0101.33
2024-0201.5
2024-0301.5
2024-0402
2024-0501
2024-0601.45
2024-0701.6
2024-0801
2024-0901.8
2024-1001.71
2024-1101.5
2024-1201.63
2025-0102.83
2025-0202.33
2025-0302.33
2025-0402.2
2025-0501.55
2025-0602.29
2025-0701.57
2025-0801.33
2025-0903.6
2025-1001.71
2025-1102.4
2025-1202.6
2026-0102.25
2026-0201.45
2026-0302.5
2026-0401.67
2026-0501.83
2026-0602.71
This device (reports/month)Average device in HWM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K181347 — cites (transitively): K072791 (d1), K082698 (d1), K090707 (d1), K091088 (d1), K101302 (d1), K150788 (d1), K160547 (d1), K162264 (d1), K170503 (d1), K172009 (d1), K172941 (d1), P950002 (d1), P950019 (d1), P960025 (d1), K110843 (d2), K130699 (d2), K150481 (d2), K160125 (d2), K080588 (d2), K092193 (d2), K093669 (d2), K112095 (d2), K122588 (d2), K143258 (d2), K141665 (d2), K123767 (d2), K131533 (d2), K131547 (d2), K133614 (d2), K051454 (d3), K063399 (d3), K080024 (d3), K080699 (d3), K102293 (d3), K031672 (d3), K103169 (d3), K091253 (d3), K972718 (d3), K071795 (d3), K090816 (d3), K113348 (d3), K120918 (d3), K123045 (d3), K123231 (d3), K130820 (d3), K131082 (d3), K132601 (d3), K133455 (d3), K140319 (d3), K103111 (d3), K112316 (d3), K100945 (d3), K113138 (d3), K113561 (d3), K141405 (d3), K072991 (d3), K133494 (d3), K150362 (d3), K152304 (d3), K080401 (d4), K072970 (d4), K093242 (d4), K073202 (d4), K083626 (d4), K081917 (d4), K083894 (d4), K031635 (d4), K080568 (d4), K101923 (d4), K080537 (d4), K023570 (d4), K062933 (d4), K073291 (d4), K082310 (d4), K091278 (d4), K100042 (d4), K130548 (d4), K043206 (d4), K133623 (d4), K073285 (d4), K092211 (d4), K120031 (d4), K122630 (d4), K110632 (d4), K122967 (d4), K071724 (d4), K081968 (d4), K100089 (d4), K131372 (d4), K081611 (d4), K140003 (d4), K140921 (d4), K142050 (d4), K142264 (d4), K060506 (d4), K123486 (d4), K132624 (d4), K143393 (d4), K143616 (d4), K043479 (d5), P970015 (d5), K073348 (d5), K062083 (d5), K072253 (d5), K083475 (d5), K080971 (d5), K092070 (d5), K072160 (d5), K092901 (d5), K090064 (d5), K031729 (d5), K040267 (d5), K042883 (d5), K042993 (d5), K051146 (d5), K051380 (d5), K051977 (d5), K053514 (d5), K061521 (d5), K072221 (d5), K072575 (d5), K123166 (d5), K123206 (d5), K130177 (d5), K053340 (d5), K100391 (d5), K082262 (d6), K042871 (d6), K052888 (d6), K050539 (d6), K063423 (d6), K974556 (d6), P980048 (d6) — cited as predicate by K182987, K211474, K213935

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

Manufacturer compliance record — Osseus Fusion Systems, LLC

  • NAI 2018-08-24 Osseus Fusion Systems, LLC · 0 citations
  • NAI 2018-08-24 Osseus Fusion Systems, LLC · 0 citations
  • VAI 2015-04-23 Osseus Fusion Systems, LLC · 0 citations
  • VAI 2015-04-23 Osseus Fusion Systems, LLC · 0 citations