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Restrictor

Model B000-1185 · Howmedica Osteonics Corp. · DI 07613153768258

JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350

UDILibrary device dossier · generated 2026-09-15 · 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.

12232019-01: 0 reports for this device; peer average 3.3/device2019-02: 0 reports for this device; peer average 2.66/device2019-03: 0 reports for this device; peer average 2.83/device2019-04: 0 reports for this device; peer average 2.75/device2019-05: 0 reports for this device; peer average 2.19/device2019-06: 0 reports for this device; peer average 1.9/device2019-07: 0 reports for this device; peer average 2.02/device2019-08: 0 reports for this device; peer average 2.09/device2019-09: 0 reports for this device; peer average 2.42/device2019-10: 0 reports for this device; peer average 2.46/device2019-11: 0 reports for this device; peer average 1.96/device2019-12: 0 reports for this device; peer average 2.32/device2020-01: 0 reports for this device; peer average 2.63/device2020-02: 0 reports for this device; peer average 2.55/device2020-03: 0 reports for this device; peer average 3.32/device2020-04: 0 reports for this device; peer average 2.14/device2020-05: 0 reports for this device; peer average 2.36/device2020-06: 0 reports for this device; peer average 1.89/device2020-07: 0 reports for this device; peer average 2.48/device2020-08: 0 reports for this device; peer average 1.89/device2020-09: 0 reports for this device; peer average 2.22/device2020-10: 0 reports for this device; peer average 2.44/device2020-11: 0 reports for this device; peer average 2.16/device2020-12: 0 reports for this device; peer average 2.16/device2021-01: 0 reports for this device; peer average 2.23/device2021-02: 0 reports for this device; peer average 1.95/device2021-03: 0 reports for this device; peer average 1.98/device2021-04: 0 reports for this device; peer average 1.88/device2021-05: 0 reports for this device; peer average 1.94/device2021-06: 0 reports for this device; peer average 2.35/device2021-07: 0 reports for this device; peer average 2.15/device2021-08: 0 reports for this device; peer average 1.92/device2021-09: 0 reports for this device; peer average 2.11/device2021-10: 0 reports for this device; peer average 1.98/device2021-11: 0 reports for this device; peer average 2.08/device2021-12: 0 reports for this device; peer average 2.29/device2022-01: 0 reports for this device; peer average 1.87/device2022-02: 0 reports for this device; peer average 2.34/device2022-03: 0 reports for this device; peer average 1.87/device2022-04: 0 reports for this device; peer average 2.13/device2022-05: 0 reports for this device; peer average 1.9/device2022-06: 0 reports for this device; peer average 2.02/device2022-07: 0 reports for this device; peer average 1.96/device2022-08: 0 reports for this device; peer average 2.07/device2022-09: 0 reports for this device; peer average 1.96/device2022-10: 0 reports for this device; peer average 1.99/device2022-11: 0 reports for this device; peer average 2.12/device2022-12: 0 reports for this device; peer average 2.02/device2023-01: 0 reports for this device; peer average 1.66/device2023-02: 0 reports for this device; peer average 1.87/device2023-03: 0 reports for this device; peer average 2.02/device2023-04: 0 reports for this device; peer average 1.93/device2023-05: 0 reports for this device; peer average 2.1/device2023-06: 0 reports for this device; peer average 2.12/device2023-07: 0 reports for this device; peer average 2.05/device2023-08: 0 reports for this device; peer average 2.02/device2023-09: 0 reports for this device; peer average 2.03/device2023-10: 0 reports for this device; peer average 1.5/device2023-11: 0 reports for this device; peer average 1.54/device2023-12: 0 reports for this device; peer average 1.57/device2024-01: 0 reports for this device; peer average 1.63/device2024-02: 0 reports for this device; peer average 1.82/device2024-03: 0 reports for this device; peer average 1.96/device2024-04: 0 reports for this device; peer average 1.66/device2024-05: 0 reports for this device; peer average 2.16/device2024-06: 0 reports for this device; peer average 1.89/device2024-07: 0 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 1.84/device2024-09: 0 reports for this device; peer average 1.96/device2024-10: 0 reports for this device; peer average 1.6/device2024-11: 0 reports for this device; peer average 1.48/device2024-12: 0 reports for this device; peer average 1.48/device2025-01: 0 reports for this device; peer average 1.55/device2025-02: 0 reports for this device; peer average 1.41/device2025-03: 0 reports for this device; peer average 1.62/device2025-04: 0 reports for this device; peer average 1.71/device2025-05: 0 reports for this device; peer average 1.44/device2025-06: 0 reports for this device; peer average 1.69/device2025-07: 0 reports for this device; peer average 1.64/device2025-08: 0 reports for this device; peer average 1.47/device2025-09: 0 reports for this device; peer average 1.77/device2025-10: 0 reports for this device; peer average 1.67/device2025-11: 0 reports for this device; peer average 1.87/device2025-12: 0 reports for this device; peer average 1.85/device2026-01: 0 reports for this device; peer average 2.01/device2026-02: 0 reports for this device; peer average 1.55/device2026-03: 0 reports for this device; peer average 2.14/device2026-04: 0 reports for this device; peer average 1.79/device2026-05: 0 reports for this device; peer average 1.81/device2026-06: 0 reports for this device; peer average 1.65/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.3
2019-0202.66
2019-0302.83
2019-0402.75
2019-0502.19
2019-0601.9
2019-0702.02
2019-0802.09
2019-0902.42
2019-1002.46
2019-1101.96
2019-1202.32
2020-0102.63
2020-0202.55
2020-0303.32
2020-0402.14
2020-0502.36
2020-0601.89
2020-0702.48
2020-0801.89
2020-0902.22
2020-1002.44
2020-1102.16
2020-1202.16
2021-0102.23
2021-0201.95
2021-0301.98
2021-0401.88
2021-0501.94
2021-0602.35
2021-0702.15
2021-0801.92
2021-0902.11
2021-1001.98
2021-1102.08
2021-1202.29
2022-0101.87
2022-0202.34
2022-0301.87
2022-0402.13
2022-0501.9
2022-0602.02
2022-0701.96
2022-0802.07
2022-0901.96
2022-1001.99
2022-1102.12
2022-1202.02
2023-0101.66
2023-0201.87
2023-0302.02
2023-0401.93
2023-0502.1
2023-0602.12
2023-0702.05
2023-0802.02
2023-0902.03
2023-1001.5
2023-1101.54
2023-1201.57
2024-0101.63
2024-0201.82
2024-0301.96
2024-0401.66
2024-0502.16
2024-0601.89
2024-0701.67
2024-0801.84
2024-0901.96
2024-1001.6
2024-1101.48
2024-1201.48
2025-0101.55
2025-0201.41
2025-0301.62
2025-0401.71
2025-0501.44
2025-0601.69
2025-0701.64
2025-0801.47
2025-0901.77
2025-1001.67
2025-1101.87
2025-1201.85
2026-0102.01
2026-0201.55
2026-0302.14
2026-0401.79
2026-0501.81
2026-0601.65
This device (reports/month)Average device in JDI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

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

K924323 — 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