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AMK

Model 1688-31-025 · DEPUY ORTHOPAEDICS, INC. · DI 10603295067023

HRY — Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3530

HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3520

JDB — Prosthesis, Elbow, Semi-Constrained, Cemented · Class II · 21 CFR 888.3160

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

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560

KWT — Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3650

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 2.49/device2019-02: 0 reports for this device; peer average 2.23/device2019-03: 0 reports for this device; peer average 2.06/device2019-04: 0 reports for this device; peer average 2.28/device2019-05: 0 reports for this device; peer average 1.95/device2019-06: 0 reports for this device; peer average 2.07/device2019-07: 0 reports for this device; peer average 2/device2019-08: 0 reports for this device; peer average 2.15/device2019-09: 0 reports for this device; peer average 2.08/device2019-10: 0 reports for this device; peer average 2.36/device2019-11: 0 reports for this device; peer average 2.53/device2019-12: 0 reports for this device; peer average 2.36/device2020-01: 0 reports for this device; peer average 2.39/device2020-02: 0 reports for this device; peer average 2.65/device2020-03: 0 reports for this device; peer average 2.61/device2020-04: 0 reports for this device; peer average 2.14/device2020-05: 0 reports for this device; peer average 1.99/device2020-06: 0 reports for this device; peer average 2.18/device2020-07: 0 reports for this device; peer average 2.7/device2020-08: 0 reports for this device; peer average 2.64/device2020-09: 0 reports for this device; peer average 2.38/device2020-10: 0 reports for this device; peer average 2.93/device2020-11: 0 reports for this device; peer average 2.9/device2020-12: 0 reports for this device; peer average 3.12/device2021-01: 0 reports for this device; peer average 2.63/device2021-02: 0 reports for this device; peer average 2.55/device2021-03: 0 reports for this device; peer average 2.39/device2021-04: 0 reports for this device; peer average 2.29/device2021-05: 0 reports for this device; peer average 2.5/device2021-06: 0 reports for this device; peer average 2.44/device2021-07: 0 reports for this device; peer average 2.43/device2021-08: 0 reports for this device; peer average 2.08/device2021-09: 0 reports for this device; peer average 2.52/device2021-10: 0 reports for this device; peer average 2.11/device2021-11: 0 reports for this device; peer average 2.36/device2021-12: 0 reports for this device; peer average 2.5/device2022-01: 0 reports for this device; peer average 2.13/device2022-02: 0 reports for this device; peer average 2.58/device2022-03: 0 reports for this device; peer average 2.25/device2022-04: 0 reports for this device; peer average 2.3/device2022-05: 0 reports for this device; peer average 2.53/device2022-06: 0 reports for this device; peer average 2.17/device2022-07: 0 reports for this device; peer average 2.23/device2022-08: 0 reports for this device; peer average 2.17/device2022-09: 0 reports for this device; peer average 2.39/device2022-10: 0 reports for this device; peer average 2.25/device2022-11: 0 reports for this device; peer average 2.26/device2022-12: 0 reports for this device; peer average 2.03/device2023-01: 0 reports for this device; peer average 2.05/device2023-02: 0 reports for this device; peer average 2.15/device2023-03: 0 reports for this device; peer average 2.19/device2023-04: 0 reports for this device; peer average 2.2/device2023-05: 0 reports for this device; peer average 2.31/device2023-06: 0 reports for this device; peer average 2.3/device2023-07: 0 reports for this device; peer average 2.04/device2023-08: 0 reports for this device; peer average 1.85/device2023-09: 0 reports for this device; peer average 1.81/device2023-10: 0 reports for this device; peer average 1.61/device2023-11: 0 reports for this device; peer average 1.72/device2023-12: 0 reports for this device; peer average 1.65/device2024-01: 0 reports for this device; peer average 1.68/device2024-02: 0 reports for this device; peer average 1.82/device2024-03: 0 reports for this device; peer average 1.85/device2024-04: 0 reports for this device; peer average 1.72/device2024-05: 0 reports for this device; peer average 1.95/device2024-06: 0 reports for this device; peer average 1.96/device2024-07: 0 reports for this device; peer average 1.82/device2024-08: 0 reports for this device; peer average 2.14/device2024-09: 0 reports for this device; peer average 2.08/device2024-10: 0 reports for this device; peer average 1.89/device2024-11: 0 reports for this device; peer average 1.85/device2024-12: 0 reports for this device; peer average 1.96/device2025-01: 0 reports for this device; peer average 2.1/device2025-02: 0 reports for this device; peer average 1.71/device2025-03: 0 reports for this device; peer average 1.79/device2025-04: 0 reports for this device; peer average 1.76/device2025-05: 0 reports for this device; peer average 1.72/device2025-06: 0 reports for this device; peer average 1.78/device2025-07: 0 reports for this device; peer average 1.66/device2025-08: 0 reports for this device; peer average 1.64/device2025-09: 0 reports for this device; peer average 1.69/device2025-10: 0 reports for this device; peer average 1.58/device2025-11: 0 reports for this device; peer average 1.77/device2025-12: 0 reports for this device; peer average 1.78/device2026-01: 0 reports for this device; peer average 1.71/device2026-02: 0 reports for this device; peer average 1.56/device2026-03: 0 reports for this device; peer average 2.02/device2026-04: 0 reports for this device; peer average 1.76/device2026-05: 0 reports for this device; peer average 1.76/device2026-06: 0 reports for this device; peer average 1.69/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.49
2019-0202.23
2019-0302.06
2019-0402.28
2019-0501.95
2019-0602.07
2019-0702
2019-0802.15
2019-0902.08
2019-1002.36
2019-1102.53
2019-1202.36
2020-0102.39
2020-0202.65
2020-0302.61
2020-0402.14
2020-0501.99
2020-0602.18
2020-0702.7
2020-0802.64
2020-0902.38
2020-1002.93
2020-1102.9
2020-1203.12
2021-0102.63
2021-0202.55
2021-0302.39
2021-0402.29
2021-0502.5
2021-0602.44
2021-0702.43
2021-0802.08
2021-0902.52
2021-1002.11
2021-1102.36
2021-1202.5
2022-0102.13
2022-0202.58
2022-0302.25
2022-0402.3
2022-0502.53
2022-0602.17
2022-0702.23
2022-0802.17
2022-0902.39
2022-1002.25
2022-1102.26
2022-1202.03
2023-0102.05
2023-0202.15
2023-0302.19
2023-0402.2
2023-0502.31
2023-0602.3
2023-0702.04
2023-0801.85
2023-0901.81
2023-1001.61
2023-1101.72
2023-1201.65
2024-0101.68
2024-0201.82
2024-0301.85
2024-0401.72
2024-0501.95
2024-0601.96
2024-0701.82
2024-0802.14
2024-0902.08
2024-1001.89
2024-1101.85
2024-1201.96
2025-0102.1
2025-0201.71
2025-0301.79
2025-0401.76
2025-0501.72
2025-0601.78
2025-0701.66
2025-0801.64
2025-0901.69
2025-1001.58
2025-1101.77
2025-1201.78
2026-0101.71
2026-0201.56
2026-0302.02
2026-0401.76
2026-0501.76
2026-0601.69
This device (reports/month)Average device in HRY, HSX, JDB, JDI, JWH, KWT (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K864671 — cited as predicate by K100981

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

Manufacturer compliance record — DEPUY ORTHOPAEDICS, INC.

  • Warning Letter 2011-12-08 DePuy Orthopaedics, Inc.
  • Warning Letter 2010-08-19 DePuy Orthopaedics, Inc.
  • NAI 2024-03-28 DePuy Orthopaedics, Inc. · 0 citations
  • NAI 2022-05-12 DePuy Orthopaedics, Inc. · 0 citations
  • NAI 2019-11-08 DePuy Orthopaedics, Inc. · 0 citations
  • VAI 2017-09-01 DePuy Orthopaedics, Inc. · 2 citations
  • VAI 2015-10-01 DePuy Orthopaedics, Inc. · 2 citations
  • NAI 2015-09-24 DePuy Orthopaedics, Inc. · 0 citations
  • VAI 2012-11-26 DePuy Orthopaedics, Inc. · 6 citations
  • NAI 2011-08-16 DePuy Orthopaedics, Inc. · 0 citations
  • OAI 2011-06-07 DePuy Orthopaedics, Inc. · 6 citations