Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

3DP Lumbar Interbody System

Model 1 · Genesys Orthopedics Systems LLC · DI M719GP5330

HTF — Curette · Class I · 21 CFR 878.4800

UDILibrary device dossier · generated 2026-09-06 · 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.

12342019-02: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 3/device2021-01: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 3/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1.33/device2021-12: 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 3/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 2/device2023-09: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 2.33/device2025-04: 0 reports for this device; peer average 4/device2025-11: 0 reports for this device; peer average 1.8/device2025-12: 0 reports for this device; peer average 3.67/device2026-03: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 1/device020810020401030506091203041011020305060809101201061101020411120306
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0801
2019-1002
2020-0201
2020-0403
2021-0102
2021-0303
2021-0501
2021-0601
2021-0901.33
2021-1203
2022-0303
2022-0403
2022-1002
2022-1102
2023-0201
2023-0301
2023-0501
2023-0602
2023-0802
2023-0901
2023-1002
2023-1202
2024-0101
2024-0601
2024-1101
2025-0101
2025-0202.33
2025-0404
2025-1101.8
2025-1203.67
2026-0302
2026-0601
This device (reports/month)Average device in HTF (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