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3DP Lumbar Interbody System

Model 1 · Genesys Orthopedics Systems LLC · DI M719GP53160

HTX — Rongeur · Class I · 21 CFR 888.4540

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.

23562019-04: 0 reports for this device; peer average 1.67/device2019-06: 0 reports for this device; peer average 1.67/device2019-08: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1.83/device2019-11: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 1.5/device2020-04: 0 reports for this device; peer average 3/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 4/device2020-09: 0 reports for this device; peer average 2.38/device2020-10: 0 reports for this device; peer average 1.5/device2020-11: 0 reports for this device; peer average 1.5/device2020-12: 0 reports for this device; peer average 5/device2021-01: 0 reports for this device; peer average 3/device2021-02: 0 reports for this device; peer average 5.5/device2021-03: 0 reports for this device; peer average 2.67/device2021-04: 0 reports for this device; peer average 4/device2021-05: 0 reports for this device; peer average 6/device2021-06: 0 reports for this device; peer average 2.5/device2021-11: 0 reports for this device; peer average 3/device2021-12: 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 1/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 1.5/device2022-07: 0 reports for this device; peer average 1.5/device2022-08: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1.33/device2023-01: 0 reports for this device; peer average 3.33/device2023-05: 0 reports for this device; peer average 1.33/device2023-06: 0 reports for this device; peer average 3.5/device2023-08: 0 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 1/device2024-02: 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/device2024-07: 0 reports for this device; peer average 1.5/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1.33/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 1.67/device2025-01: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 2.5/device2025-12: 0 reports for this device; peer average 1.33/device2026-03: 0 reports for this device; peer average 4/device2026-04: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 2/device04060810110102030406070910111201020304050611120203040506070810111201050608091112020506070809101112010203060912030406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401.67
2019-0601.67
2019-0801
2019-1001.83
2019-1102
2020-0102
2020-0202
2020-0301.5
2020-0403
2020-0602
2020-0704
2020-0902.38
2020-1001.5
2020-1101.5
2020-1205
2021-0103
2021-0205.5
2021-0302.67
2021-0404
2021-0506
2021-0602.5
2021-1103
2021-1202
2022-0203
2022-0301
2022-0401
2022-0501
2022-0601.5
2022-0701.5
2022-0802
2022-1001
2022-1101
2022-1201.33
2023-0103.33
2023-0501.33
2023-0603.5
2023-0802
2023-0901
2023-1102
2023-1201
2024-0202
2024-0501
2024-0601
2024-0701.5
2024-0802
2024-0901.33
2024-1001
2024-1101
2024-1201.67
2025-0101.5
2025-0202
2025-0301
2025-0601
2025-0902.5
2025-1201.33
2026-0304
2026-0401.5
2026-0602
This device (reports/month)Average device in HTX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K182987 — cites (transitively): K103034 (d1), K153123 (d1), K161404 (d1), K161438 (d1), K170503 (d1), K181347 (d1), K043479 (d2), K090064 (d2), K091088 (d2), P000028 (d2), P950019 (d2), P960025 (d2), P980048 (d2), K073291 (d2), K082698 (d2), K090353 (d2), K111525 (d2), K130548 (d2), K133340 (d2), K143143 (d2), K120368 (d2), K130913 (d2), K151406 (d2), K112561 (d2), K123045 (d2), K080588 (d2), K092193 (d2), K093669 (d2), K112095 (d2), K122588 (d2), K143258 (d2), K072791 (d2), K090707 (d2), K101302 (d2), K150788 (d2), K160547 (d2), K162264 (d2), K172009 (d2), K172941 (d2), P950002 (d2), K102293 (d3), K082252 (d3), K100043 (d3), K102090 (d3), K033926 (d3), K071795 (d3), K094025 (d3), K103731 (d3), K092901 (d3), K111166 (d3), K121693 (d3), K123969 (d3), K103111 (d3), K112316 (d3), K133614 (d3), K132738 (d3), K142193 (d3), K110843 (d3), K130699 (d3), K150481 (d3), K160125 (d3), K141665 (d3), K123767 (d3), K131533 (d3), K131547 (d3), K082262 (d4), K052261 (d4), K072970 (d4), K093242 (d4), K073202 (d4), K083626 (d4), K051454 (d4), K063399 (d4), K080024 (d4), K080699 (d4), K071724 (d4), K081968 (d4), K083894 (d4), K080822 (d4), K031672 (d4), K103169 (d4), K091253 (d4), K972718 (d4), K073470 (d4), K090566 (d4), K090816 (d4), K113348 (d4), K120918 (d4), K123231 (d4), K130820 (d4), K131082 (d4), K132601 (d4), K133455 (d4), K140319 (d4), K100945 (d4), K113138 (d4), K113561 (d4), K141405 (d4), K072991 (d4), K133494 (d4), K150362 (d4), K152304 (d4), K080401 (d5), K081917 (d5), K031635 (d5), K080568 (d5), K101923 (d5), K080537 (d5), K023570 (d5), K062933 (d5), K082310 (d5), K091278 (d5), K100042 (d5), K043206 (d5), K133623 (d5), K073285 (d5), K092211 (d5), K120031 (d5), K122630 (d5), K110632 (d5), K122967 (d5), K100089 (d5), K131372 (d5), K081611 (d5), K140003 (d5), K140921 (d5), K142050 (d5), K142264 (d5), K060506 (d5), K123486 (d5), K132624 (d5), K143393 (d5), K143616 (d5), P970015 (d6), K073348 (d6), K062083 (d6), K072253 (d6), K083475 (d6), K080971 (d6), K092070 (d6), K072160 (d6), K031729 (d6), K040267 (d6), K042883 (d6), K042993 (d6), K051146 (d6), K051380 (d6), K051977 (d6), K053514 (d6), K061521 (d6), K072221 (d6), K072575 (d6), K123166 (d6), K123206 (d6), K130177 (d6), K053340 (d6), K100391 (d6), K042871 (d7), K052888 (d7), K050539 (d7), K063423 (d7), K974556 (d7) — cited as predicate by K191489, K220096

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

Manufacturer compliance record — Genesys Orthopedics Systems LLC

  • NAI 2023-08-10 Genesys Orthopedics Systems, LLC · 0 citations
  • VAI 2017-09-08 Genesys Orthopedics Systems, LLC · 1 citations
  • NAI 2013-06-05 Genesys Orthopedics Systems, LLC · 0 citations
  • OAI 2012-04-02 Genesys Orthopedics Systems, LLC · 5 citations