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

Alumina

Model 6565-0-136 · Howmedica Osteonics Corp. · DI 04546540390486

LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353

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 (2)

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.

Injury: 2

12232019-01: 0 reports for this device; peer average 2.72/device2019-02: 0 reports for this device; peer average 2.45/device2019-03: 0 reports for this device; peer average 2.79/device2019-04: 0 reports for this device; peer average 2.65/device2019-05: 0 reports for this device; peer average 2.07/device2019-06: 0 reports for this device; peer average 1.85/device2019-07: 0 reports for this device; peer average 1.73/device2019-08: 0 reports for this device; peer average 2.19/device2019-09: 1 reports for this device; peer average 2.2/device2019-10: 0 reports for this device; peer average 2.5/device2019-11: 0 reports for this device; peer average 2.2/device2019-12: 0 reports for this device; peer average 2.55/device2020-01: 0 reports for this device; peer average 3.08/device2020-02: 0 reports for this device; peer average 2.52/device2020-03: 0 reports for this device; peer average 3.17/device2020-04: 0 reports for this device; peer average 2.37/device2020-05: 0 reports for this device; peer average 2.26/device2020-06: 0 reports for this device; peer average 2.13/device2020-07: 0 reports for this device; peer average 2.62/device2020-08: 0 reports for this device; peer average 2.21/device2020-09: 0 reports for this device; peer average 2.8/device2020-10: 0 reports for this device; peer average 2.76/device2020-11: 0 reports for this device; peer average 2.4/device2020-12: 0 reports for this device; peer average 2.47/device2021-01: 0 reports for this device; peer average 2.52/device2021-02: 0 reports for this device; peer average 2.24/device2021-03: 0 reports for this device; peer average 2.2/device2021-04: 0 reports for this device; peer average 2.17/device2021-05: 0 reports for this device; peer average 2.19/device2021-06: 0 reports for this device; peer average 2.49/device2021-07: 0 reports for this device; peer average 2.58/device2021-08: 0 reports for this device; peer average 2.56/device2021-09: 0 reports for this device; peer average 2.75/device2021-10: 0 reports for this device; peer average 2.46/device2021-11: 0 reports for this device; peer average 2.22/device2021-12: 0 reports for this device; peer average 2.46/device2022-01: 0 reports for this device; peer average 2.31/device2022-02: 0 reports for this device; peer average 2.33/device2022-03: 0 reports for this device; peer average 2.38/device2022-04: 0 reports for this device; peer average 2.3/device2022-05: 0 reports for this device; peer average 2.46/device2022-06: 0 reports for this device; peer average 2.32/device2022-07: 0 reports for this device; peer average 2.32/device2022-08: 0 reports for this device; peer average 2.33/device2022-09: 0 reports for this device; peer average 2.44/device2022-10: 0 reports for this device; peer average 2.4/device2022-11: 0 reports for this device; peer average 2.48/device2022-12: 0 reports for this device; peer average 2.48/device2023-01: 0 reports for this device; peer average 2.63/device2023-02: 0 reports for this device; peer average 2.34/device2023-03: 0 reports for this device; peer average 2.47/device2023-04: 0 reports for this device; peer average 2.44/device2023-05: 0 reports for this device; peer average 2.35/device2023-06: 0 reports for this device; peer average 2.45/device2023-07: 0 reports for this device; peer average 2.31/device2023-08: 0 reports for this device; peer average 2.02/device2023-09: 0 reports for this device; peer average 2.04/device2023-10: 0 reports for this device; peer average 1.8/device2023-11: 1 reports for this device; peer average 1.78/device2023-12: 0 reports for this device; peer average 1.89/device2024-01: 0 reports for this device; peer average 1.84/device2024-02: 0 reports for this device; peer average 2.21/device2024-03: 0 reports for this device; peer average 2.01/device2024-04: 0 reports for this device; peer average 1.91/device2024-05: 0 reports for this device; peer average 2.24/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1.82/device2024-08: 0 reports for this device; peer average 2.05/device2024-09: 0 reports for this device; peer average 2.05/device2024-10: 0 reports for this device; peer average 1.87/device2024-11: 0 reports for this device; peer average 1.99/device2024-12: 0 reports for this device; peer average 1.71/device2025-01: 0 reports for this device; peer average 2.18/device2025-02: 0 reports for this device; peer average 1.66/device2025-03: 0 reports for this device; peer average 1.85/device2025-04: 0 reports for this device; peer average 1.95/device2025-05: 0 reports for this device; peer average 1.94/device2025-06: 0 reports for this device; peer average 1.97/device2025-07: 0 reports for this device; peer average 1.92/device2025-08: 0 reports for this device; peer average 1.94/device2025-09: 0 reports for this device; peer average 1.75/device2025-10: 0 reports for this device; peer average 1.84/device2025-11: 0 reports for this device; peer average 1.9/device2025-12: 0 reports for this device; peer average 1.99/device2026-01: 0 reports for this device; peer average 2.04/device2026-02: 0 reports for this device; peer average 1.83/device2026-03: 0 reports for this device; peer average 1.98/device2026-04: 0 reports for this device; peer average 2.12/device2026-05: 0 reports for this device; peer average 1.92/device2026-06: 0 reports for this device; peer average 1.88/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.72
2019-0202.45
2019-0302.79
2019-0402.65
2019-0502.07
2019-0601.85
2019-0701.73
2019-0802.19
2019-0912.2
2019-1002.5
2019-1102.2
2019-1202.55
2020-0103.08
2020-0202.52
2020-0303.17
2020-0402.37
2020-0502.26
2020-0602.13
2020-0702.62
2020-0802.21
2020-0902.8
2020-1002.76
2020-1102.4
2020-1202.47
2021-0102.52
2021-0202.24
2021-0302.2
2021-0402.17
2021-0502.19
2021-0602.49
2021-0702.58
2021-0802.56
2021-0902.75
2021-1002.46
2021-1102.22
2021-1202.46
2022-0102.31
2022-0202.33
2022-0302.38
2022-0402.3
2022-0502.46
2022-0602.32
2022-0702.32
2022-0802.33
2022-0902.44
2022-1002.4
2022-1102.48
2022-1202.48
2023-0102.63
2023-0202.34
2023-0302.47
2023-0402.44
2023-0502.35
2023-0602.45
2023-0702.31
2023-0802.02
2023-0902.04
2023-1001.8
2023-1111.78
2023-1201.89
2024-0101.84
2024-0202.21
2024-0302.01
2024-0401.91
2024-0502.24
2024-0602
2024-0701.82
2024-0802.05
2024-0902.05
2024-1001.87
2024-1101.99
2024-1201.71
2025-0102.18
2025-0201.66
2025-0301.85
2025-0401.95
2025-0501.94
2025-0601.97
2025-0701.92
2025-0801.94
2025-0901.75
2025-1001.84
2025-1101.9
2025-1201.99
2026-0102.04
2026-0201.83
2026-0301.98
2026-0402.12
2026-0501.92
2026-0601.88
This device (reports/month)Average device in LZO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K023901 — cited as predicate by K153345

K173499 — cites (transitively): K011623 (d1), K051741 (d1), K110290 (d1), K121308 (d1), K130610 (d1), K142295 (d1), K153345 (d1), K010757 (d2), K022077 (d2), K061434 (d2), K070885 (d2), K972228 (d2), K993601 (d2), K052639 (d2), K960658 (d2), K003379 (d2), K003391 (d2), K010170 (d2), K013676 (d2), K014226 (d2), K020497 (d2), K020572 (d2), K021310 (d2), K021911 (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), K052718 (d2), K061654 (d2), K062419 (d2), K072020 (d2), K081171 (d2), K093644 (d2), K102019 (d2), K103233 (d2), K103479 (d2), K120578 (d2), K122853 (d2), K123604 (d2), K142462 (d2), K143085 (d2), K151264 (d2), K894124 (d2), K900836 (d2), K902365 (d2), K903362 (d2), K910988 (d2), K914406 (d2), K920868 (d2), K942809 (d2), K943549 (d2), K954077 (d2), K971409 (d2), K983226 (d2), K983382 (d2), K983502 (d2), K991952 (d2), K992570 (d2), K994366 (d2), P960047 (d2), K061067 (d3), K905258 (d3) — cited as predicate by K191414, K193429, K233498

K243784 — cites (transitively): K121308 (d1), K233498 (d1), K900438 (d1), K974685 (d1), K153345 (d2), K173499 (d2), K182468 (d2), K191358 (d2), K191414 (d2), K202016 (d2), K210893 (d2), K212187 (d2), K213701 (d2), K220376 (d2), K220731 (d2), K220838 (d2), K222632 (d2), K003379 (d3), K003391 (d3), K010170 (d3), K010757 (d3), K011623 (d3), K013676 (d3), K014226 (d3), K020497 (d3), K020572 (d3), K021310 (d3), K021911 (d3), K022077 (d3), K022555 (d3), K023102 (d3), K023901 (d3), K031730 (d3), K031744 (d3), K033716 (d3), K040412 (d3), K041170 (d3), K041940 (d3), K051588 (d3), K051737 (d3), K051738 (d3), K051741 (d3), K052718 (d3), K061434 (d3), K061654 (d3), K062419 (d3), K070885 (d3), K072020 (d3), K081171 (d3), K093644 (d3), K102019 (d3), K103233 (d3), K103479 (d3), K110290 (d3), K120578 (d3), K122853 (d3), K123604 (d3), K142462 (d3), K143085 (d3), K151264 (d3), K894124 (d3), K900836 (d3), K902365 (d3), K903362 (d3), K910988 (d3), K914406 (d3), K920868 (d3), K942809 (d3), K943549 (d3), K954077 (d3), K971409 (d3), K983226 (d3), K983382 (d3), K983502 (d3), K991952 (d3), K992570 (d3), K993601 (d3), K994366 (d3), P960047 (d3), K130610 (d3), K142295 (d3), K112556 (d3), K172634 (d3), K171768 (d3), K974054 (d3), K980843 (d3), K070170 (d3), K900926 (d3), K934058 (d3), K945294 (d3), K953818 (d3), K961283 (d3), K971741 (d3), K013106 (d3), K022549 (d3), K040734 (d3), K050138 (d3), K051363 (d3), K193233 (d3), K111848 (d3), K191449 (d3), K193429 (d3), K211703 (d3), K213129 (d3), K924323 (d3), K951860 (d3), K800207 (d3), K980774 (d3), K061067 (d4), K972228 (d4), K052639 (d4), K960658 (d4), K905258 (d4), K161569 (d4), K031729 (d4), K040267 (d4), K042883 (d4), K051146 (d4), K063423 (d4), K072221 (d4), K030153 (d4), K901240 (d4), K173849 (d4), K174399 (d4), K193427 (d4), K150862 (d4), K160907 (d4), K202472 (d4), K011489 (d5), K123991 (d5), K142606 (d5), K152304 (d5), K944213 (d5), K051380 (d5), K141056 (d5), K172326 (d5), K193398 (d5), K042992 (d6), K070554 (d6), K812672 (d6), K903084 (d6), K042067 (d6), K042993 (d6), K050539 (d6), K053514 (d6), K061521 (d6), K062037 (d6), K070095 (d6), K072575 (d6), K123166 (d6), K123486 (d6), K112802 (d6), K060506 (d6), K132624 (d6), K143393 (d6), K143616 (d6), K071881 (d6), K090763 (d6), K150307 (d6), K001911 (d6), K001991 (d6), K170339 (d6), K192919 (d6), K041906 (d7), K042842 (d7), K052792 (d7), K070369 (d7), K094035 (d7), K102487 (d7), K974556 (d7), K072160 (d7), K051977 (d7), K053340 (d7), K100391 (d7), K133039 (d7), K013352 (d7), K023453 (d7), K030122 (d7), K000306 (d7), K031495 (d7), K192191 (d7), K032396 (d8), K050327 (d8), K071535 (d8), K073102 (d8), K083762 (d8), K935484 (d8), K950827 (d8), K970501 (d8), K042871 (d8), K052888 (d8) — cited as predicate by K250989, K252459

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