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Bone Plug

Model 6215-5-001 · Howmedica Osteonics Corp. · DI 07613327036664

LZN — Cement Obturator · Class II · 21 CFR 878.3300

UDILibrary device dossier · generated 2026-09-12 · 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.

12232019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2/device2019-04: 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/device2019-10: 0 reports for this device; peer average 3/device2019-12: 0 reports for this device; peer average 2/device2021-05: 0 reports for this device; peer average 3/device2021-07: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 2/device2023-05: 0 reports for this device; peer average 3/device2023-06: 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/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1.5/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 1/device0203040708101205071112070905060809101101020406070809100103050810110102030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0302
2019-0402
2019-0701
2019-0801
2019-1003
2019-1202
2021-0503
2021-0703
2021-1101
2021-1201
2022-0703
2022-0902
2023-0503
2023-0601
2023-0801
2023-0901
2023-1002
2023-1102
2024-0101
2024-0202
2024-0402
2024-0601
2024-0701
2024-0801
2024-0902
2024-1001
2025-0101
2025-0302
2025-0501
2025-0802
2025-1001
2025-1101.5
2026-0101
2026-0201.5
2026-0302
2026-0402
2026-0501
This device (reports/month)Average device in LZN (reports/device/month)

Regulatory clearances

  • K220838 SESE 2022-05-20 (k number procode)

Predicate lineage

K220838 — cites (transitively): K153345 (d1), K914406 (d1), K924323 (d1), K951860 (d1), K003379 (d2), K003391 (d2), K010170 (d2), K010757 (d2), K011623 (d2), K013676 (d2), K014226 (d2), K020497 (d2), K020572 (d2), K021310 (d2), K021911 (d2), K022077 (d2), K022555 (d2), K023102 (d2), K023901 (d2), K031730 (d2), K031744 (d2), K033716 (d2), K040412 (d2), K041170 (d2), K041940 (d2), K051588 (d2), K051737 (d2), K051738 (d2), K051741 (d2), K052718 (d2), K061434 (d2), K061654 (d2), K062419 (d2), K070885 (d2), K072020 (d2), K081171 (d2), K093644 (d2), K102019 (d2), K103233 (d2), K103479 (d2), K110290 (d2), K120578 (d2), K121308 (d2), K122853 (d2), K123604 (d2), K142462 (d2), K143085 (d2), K151264 (d2), K894124 (d2), K900836 (d2), K902365 (d2), K903362 (d2), K910988 (d2), K920868 (d2), K942809 (d2), K943549 (d2), K954077 (d2), K971409 (d2), K983226 (d2), K983382 (d2), K983502 (d2), K991952 (d2), K992570 (d2), K993601 (d2), K994366 (d2), P960047 (d2), K061067 (d3), K972228 (d3), K905258 (d3) — cited as predicate by K233498

K951860 — cited as predicate by K220838

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

Manufacturer compliance record — Howmedica Osteonics Corp.

  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • NAI 2021-06-22 Howmedica Osteonics Corp. · 0 citations
  • VAI 2015-03-09 Howmedica Osteonics Corp. · 3 citations
  • VAI 2013-04-16 Howmedica Osteonics Corp. · 3 citations
  • NAI 2010-01-15 Howmedica Osteonics Corp. · 0 citations