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Continuum® Trilogy® Allofit®

Model 00-8732-014-36 · Zimmer, Inc. · DI 00889024147720

JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350

LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358

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

OQGHip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented · Class II · 21 CFR 888.3358

OQHHip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented · Class II · 21 CFR 888.3350

OQIHip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented · Class II · 21 CFR 888.3353

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.

12332019-01: 0 reports for this device; peer average 3.28/device2019-02: 0 reports for this device; peer average 2.79/device2019-03: 0 reports for this device; peer average 3.13/device2019-04: 0 reports for this device; peer average 2.93/device2019-05: 0 reports for this device; peer average 2.27/device2019-06: 0 reports for this device; peer average 1.95/device2019-07: 0 reports for this device; peer average 1.97/device2019-08: 0 reports for this device; peer average 2.24/device2019-09: 0 reports for this device; peer average 2.56/device2019-10: 0 reports for this device; peer average 2.77/device2019-11: 0 reports for this device; peer average 2.28/device2019-12: 0 reports for this device; peer average 2.65/device2020-01: 0 reports for this device; peer average 3.01/device2020-02: 0 reports for this device; peer average 2.69/device2020-03: 0 reports for this device; peer average 3.44/device2020-04: 0 reports for this device; peer average 2.35/device2020-05: 0 reports for this device; peer average 2.38/device2020-06: 0 reports for this device; peer average 2.14/device2020-07: 0 reports for this device; peer average 2.6/device2020-08: 0 reports for this device; peer average 2.11/device2020-09: 0 reports for this device; peer average 2.7/device2020-10: 0 reports for this device; peer average 2.7/device2020-11: 0 reports for this device; peer average 2.45/device2020-12: 0 reports for this device; peer average 2.45/device2021-01: 0 reports for this device; peer average 2.57/device2021-02: 0 reports for this device; peer average 2.13/device2021-03: 0 reports for this device; peer average 2.17/device2021-04: 0 reports for this device; peer average 2.14/device2021-05: 0 reports for this device; peer average 2.09/device2021-06: 0 reports for this device; peer average 2.59/device2021-07: 0 reports for this device; peer average 2.45/device2021-08: 0 reports for this device; peer average 2.38/device2021-09: 0 reports for this device; peer average 2.51/device2021-10: 0 reports for this device; peer average 2.26/device2021-11: 0 reports for this device; peer average 2.21/device2021-12: 0 reports for this device; peer average 2.44/device2022-01: 0 reports for this device; peer average 2.17/device2022-02: 0 reports for this device; peer average 2.14/device2022-03: 0 reports for this device; peer average 2.26/device2022-04: 0 reports for this device; peer average 2.23/device2022-05: 0 reports for this device; peer average 2.19/device2022-06: 0 reports for this device; peer average 2.33/device2022-07: 0 reports for this device; peer average 2.21/device2022-08: 0 reports for this device; peer average 2.22/device2022-09: 0 reports for this device; peer average 2.21/device2022-10: 0 reports for this device; peer average 2.22/device2022-11: 0 reports for this device; peer average 2.29/device2022-12: 0 reports for this device; peer average 2.32/device2023-01: 0 reports for this device; peer average 2.25/device2023-02: 0 reports for this device; peer average 2.16/device2023-03: 0 reports for this device; peer average 2.45/device2023-04: 0 reports for this device; peer average 2.32/device2023-05: 0 reports for this device; peer average 2.24/device2023-06: 0 reports for this device; peer average 2.27/device2023-07: 0 reports for this device; peer average 2.13/device2023-08: 0 reports for this device; peer average 1.99/device2023-09: 0 reports for this device; peer average 1.96/device2023-10: 0 reports for this device; peer average 1.69/device2023-11: 0 reports for this device; peer average 1.66/device2023-12: 0 reports for this device; peer average 1.76/device2024-01: 0 reports for this device; peer average 1.8/device2024-02: 0 reports for this device; peer average 2.04/device2024-03: 0 reports for this device; peer average 1.97/device2024-04: 0 reports for this device; peer average 1.8/device2024-05: 0 reports for this device; peer average 2.09/device2024-06: 0 reports for this device; peer average 1.92/device2024-07: 0 reports for this device; peer average 1.77/device2024-08: 0 reports for this device; peer average 1.89/device2024-09: 0 reports for this device; peer average 2.02/device2024-10: 0 reports for this device; peer average 1.78/device2024-11: 0 reports for this device; peer average 1.8/device2024-12: 0 reports for this device; peer average 1.57/device2025-01: 0 reports for this device; peer average 1.95/device2025-02: 0 reports for this device; peer average 1.53/device2025-03: 0 reports for this device; peer average 1.74/device2025-04: 0 reports for this device; peer average 1.81/device2025-05: 0 reports for this device; peer average 1.74/device2025-06: 0 reports for this device; peer average 1.84/device2025-07: 0 reports for this device; peer average 1.8/device2025-08: 0 reports for this device; peer average 1.72/device2025-09: 0 reports for this device; peer average 1.77/device2025-10: 0 reports for this device; peer average 1.74/device2025-11: 0 reports for this device; peer average 1.83/device2025-12: 0 reports for this device; peer average 1.94/device2026-01: 0 reports for this device; peer average 1.96/device2026-02: 0 reports for this device; peer average 1.66/device2026-03: 0 reports for this device; peer average 1.97/device2026-04: 0 reports for this device; peer average 1.95/device2026-05: 0 reports for this device; peer average 1.77/device2026-06: 0 reports for this device; peer average 1.75/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.28
2019-0202.79
2019-0303.13
2019-0402.93
2019-0502.27
2019-0601.95
2019-0701.97
2019-0802.24
2019-0902.56
2019-1002.77
2019-1102.28
2019-1202.65
2020-0103.01
2020-0202.69
2020-0303.44
2020-0402.35
2020-0502.38
2020-0602.14
2020-0702.6
2020-0802.11
2020-0902.7
2020-1002.7
2020-1102.45
2020-1202.45
2021-0102.57
2021-0202.13
2021-0302.17
2021-0402.14
2021-0502.09
2021-0602.59
2021-0702.45
2021-0802.38
2021-0902.51
2021-1002.26
2021-1102.21
2021-1202.44
2022-0102.17
2022-0202.14
2022-0302.26
2022-0402.23
2022-0502.19
2022-0602.33
2022-0702.21
2022-0802.22
2022-0902.21
2022-1002.22
2022-1102.29
2022-1202.32
2023-0102.25
2023-0202.16
2023-0302.45
2023-0402.32
2023-0502.24
2023-0602.27
2023-0702.13
2023-0801.99
2023-0901.96
2023-1001.69
2023-1101.66
2023-1201.76
2024-0101.8
2024-0202.04
2024-0301.97
2024-0401.8
2024-0502.09
2024-0601.92
2024-0701.77
2024-0801.89
2024-0902.02
2024-1001.78
2024-1101.8
2024-1201.57
2025-0101.95
2025-0201.53
2025-0301.74
2025-0401.81
2025-0501.74
2025-0601.84
2025-0701.8
2025-0801.72
2025-0901.77
2025-1001.74
2025-1101.83
2025-1201.94
2026-0101.96
2026-0201.66
2026-0301.97
2026-0401.95
2026-0501.77
2026-0601.75
This device (reports/month)Average device in JDI, LPH, LZO, OQG, OQH, OQI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K093846 — cites (transitively): K091508 (d1) — cited as predicate by K101229, K122185, K123019, K151448, K200823

K120370 — cites (transitively): K103662 (d1), K101229 (d2), K091508 (d3), K093846 (d3) — cited as predicate by K121771, K122529, K140701, K173380, K190656, K190660, K200823, K202022

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

Manufacturer compliance record — Zimmer, Inc.

  • Warning Letter 2016-05-27 Orthosoft, Inc.
  • Warning Letter 2012-09-19 Zimmer Manufacturing B.V.
  • NAI 2022-07-27 Zimmer, Inc. · 0 citations
  • NAI 2022-07-27 Zimmer, Inc. · 0 citations
  • NAI 2020-10-01 Zimmer Manufacturing B.V. · 0 citations
  • VAI 2017-10-16 Zimmer, Inc. · 8 citations
  • VAI 2017-10-16 Zimmer, Inc. · 8 citations
  • NAI 2017-09-01 Zimmer Trabecular Metal Technology, Inc. · 0 citations
  • VAI 2017-07-27 ZIMMER ORTHOPEDIC MFG LTD · 3 citations
  • VAI 2017-07-20 Zimmer Manufacturing B.V. · 3 citations
  • VAI 2016-05-23 Zimmer Surgical Inc · 4 citations
  • OAI 2015-11-20 Zimmer, Inc. · 10 citations
  • OAI 2015-11-20 Zimmer, Inc. · 10 citations
  • VAI 2015-11-17 Zimmer Manufacturing B.V. · 4 citations
  • VAI 2015-05-11 Zimmer Trabecular Metal Technology, Inc. · 3 citations
  • VAI 2014-10-16 ZIMMER ORTHOPEDIC MFG LTD · 2 citations
  • OAI 2014-06-11 Zimmer Manufacturing B.V. · 9 citations
  • OAI 2014-05-28 Zimmer, Inc. · 12 citations
  • OAI 2014-05-28 Zimmer, Inc. · 12 citations
  • VAI 2014-02-07 Zimmer, Inc. · 2 citations
  • VAI 2014-02-07 Zimmer, Inc. · 2 citations
  • OAI 2013-08-19 Zimmer, Inc. · 0 citations