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Duracon
Model 6642-2-610 · Howmedica Osteonics Corp. · DI 04546540318459
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
JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560
KRR — Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3540
NPJ — Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560
UDILibrary device dossier · generated 2026-09-14 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1.98
2019-02
0
2.01
2019-03
0
1.65
2019-04
0
1.96
2019-05
0
1.81
2019-06
0
2.15
2019-07
0
1.98
2019-08
0
2.15
2019-09
0
1.94
2019-10
0
2.29
2019-11
0
2.8
2019-12
0
2.38
2020-01
0
2.3
2020-02
0
2.71
2020-03
0
2.32
2020-04
0
2.16
2020-05
0
1.78
2020-06
0
2.31
2020-07
0
2.84
2020-08
0
2.93
2020-09
0
2.4
2020-10
0
3.1
2020-11
0
3.16
2020-12
0
3.39
2021-01
0
2.75
2021-02
0
2.83
2021-03
0
2.56
2021-04
0
2.43
2021-05
0
2.72
2021-06
0
2.52
2021-07
0
2.5
2021-08
0
2.14
2021-09
0
2.72
2021-10
0
2.16
2021-11
0
2.51
2021-12
0
2.55
2022-01
0
2.22
2022-02
0
2.66
2022-03
0
2.4
2022-04
0
2.36
2022-05
0
2.82
2022-06
0
2.2
2022-07
0
2.33
2022-08
0
2.23
2022-09
0
2.54
2022-10
0
2.4
2022-11
0
2.33
2022-12
0
2.04
2023-01
0
2.25
2023-02
0
2.32
2023-03
0
2.26
2023-04
0
2.35
2023-05
0
2.47
2023-06
0
2.41
2023-07
0
2.04
2023-08
0
1.78
2023-09
0
1.76
2023-10
0
1.68
2023-11
0
1.83
2023-12
0
1.72
2024-01
0
1.7
2024-02
0
1.79
2024-03
0
1.83
2024-04
0
1.73
2024-05
0
1.9
2024-06
0
1.99
2024-07
0
1.91
2024-08
0
2.29
2024-09
0
2.01
2024-10
0
2
2024-11
0
1.99
2024-12
0
2.14
2025-01
0
2.3
2025-02
0
1.84
2025-03
0
1.87
2025-04
0
1.7
2025-05
0
1.74
2025-06
0
1.81
2025-07
0
1.7
2025-08
0
1.65
2025-09
0
1.71
2025-10
0
1.52
2025-11
0
1.73
2025-12
0
1.7
2026-01
0
1.56
2026-02
0
1.58
2026-03
0
2.03
2026-04
0
1.76
2026-05
0
1.78
2026-06
0
1.73
This device (reports/month)Average device in HRY, HSX, JWH, KRR, NPJ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K052917 — cited as predicate by K160461, K223528, K242831, K251665
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