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Kinectiv®
Model 65-7713-007-00 · Zimmer, Inc. · DI 00889024173088
JDL — Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component) · Class III · 21 CFR 888.3320
KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) · Class III · 21 CFR 888.3330
LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358
LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3360
LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353
MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353
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.
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
2.95
2019-02
0
2.56
2019-03
0
2.95
2019-04
0
2.73
2019-05
0
2.16
2019-06
0
1.86
2019-07
0
1.84
2019-08
0
2.2
2019-09
0
2.38
2019-10
0
2.66
2019-11
0
2.23
2019-12
0
2.52
2020-01
0
2.87
2020-02
0
2.55
2020-03
0
3.23
2020-04
0
2.32
2020-05
0
2.19
2020-06
0
2.1
2020-07
0
2.56
2020-08
0
2.09
2020-09
0
2.63
2020-10
0
2.54
2020-11
0
2.37
2020-12
0
2.38
2021-01
0
2.52
2021-02
0
2.1
2021-03
0
2.07
2021-04
0
2.13
2021-05
0
2
2021-06
0
2.54
2021-07
0
2.42
2021-08
0
2.42
2021-09
0
2.51
2021-10
0
2.28
2021-11
0
2.09
2021-12
0
2.38
2022-01
0
2.15
2022-02
0
2.04
2022-03
0
2.27
2022-04
0
2.17
2022-05
0
2.22
2022-06
0
2.3
2022-07
0
2.16
2022-08
0
2.24
2022-09
0
2.3
2022-10
0
2.21
2022-11
0
2.29
2022-12
0
2.22
2023-01
0
2.41
2023-02
0
2.23
2023-03
0
2.48
2023-04
0
2.42
2023-05
0
2.27
2023-06
0
2.41
2023-07
0
2.24
2023-08
0
2.07
2023-09
0
2.11
2023-10
0
1.78
2023-11
0
1.72
2023-12
0
1.84
2024-01
0
1.82
2024-02
0
2.19
2024-03
0
2.06
2024-04
0
1.89
2024-05
0
2.27
2024-06
0
2.06
2024-07
0
1.81
2024-08
0
2.04
2024-09
0
2.14
2024-10
0
1.9
2024-11
0
1.85
2024-12
0
1.65
2025-01
0
2.04
2025-02
0
1.61
2025-03
0
1.85
2025-04
0
1.88
2025-05
0
1.81
2025-06
0
1.9
2025-07
0
1.89
2025-08
0
1.78
2025-09
0
1.76
2025-10
0
1.74
2025-11
0
1.79
2025-12
0
1.94
2026-01
0
2.01
2026-02
0
1.73
2026-03
0
1.98
2026-04
0
1.91
2026-05
0
1.74
2026-06
0
1.82
This device (reports/month)Average device in JDL, KWA, LPH, LWJ, LZO, MEH (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K063251 — cited as predicate by K110836, K182678
K081007 — cited as predicate by K182678
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