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Bencox Hip System

Model 01.52.500 · Corentec Co., Ltd · DI 08806373892677

KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390

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

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

UDILibrary device dossier · generated 2026-09-13 · 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 3.07/device2019-02: 0 reports for this device; peer average 2.66/device2019-03: 0 reports for this device; peer average 3.07/device2019-04: 0 reports for this device; peer average 2.88/device2019-05: 0 reports for this device; peer average 2.22/device2019-06: 0 reports for this device; peer average 1.9/device2019-07: 0 reports for this device; peer average 1.87/device2019-08: 0 reports for this device; peer average 2.23/device2019-09: 0 reports for this device; peer average 2.48/device2019-10: 0 reports for this device; peer average 2.75/device2019-11: 0 reports for this device; peer average 2.29/device2019-12: 0 reports for this device; peer average 2.62/device2020-01: 0 reports for this device; peer average 3.07/device2020-02: 0 reports for this device; peer average 2.62/device2020-03: 0 reports for this device; peer average 3.32/device2020-04: 0 reports for this device; peer average 2.39/device2020-05: 0 reports for this device; peer average 2.27/device2020-06: 0 reports for this device; peer average 2.2/device2020-07: 0 reports for this device; peer average 2.62/device2020-08: 0 reports for this device; peer average 2.14/device2020-09: 0 reports for this device; peer average 2.73/device2020-10: 0 reports for this device; peer average 2.66/device2020-11: 0 reports for this device; peer average 2.45/device2020-12: 0 reports for this device; peer average 2.46/device2021-01: 0 reports for this device; peer average 2.62/device2021-02: 0 reports for this device; peer average 2.17/device2021-03: 0 reports for this device; peer average 2.15/device2021-04: 0 reports for this device; peer average 2.18/device2021-05: 0 reports for this device; peer average 2.07/device2021-06: 0 reports for this device; peer average 2.61/device2021-07: 0 reports for this device; peer average 2.46/device2021-08: 0 reports for this device; peer average 2.51/device2021-09: 0 reports for this device; peer average 2.57/device2021-10: 0 reports for this device; peer average 2.33/device2021-11: 0 reports for this device; peer average 2.17/device2021-12: 0 reports for this device; peer average 2.44/device2022-01: 0 reports for this device; peer average 2.22/device2022-02: 0 reports for this device; peer average 2.1/device2022-03: 0 reports for this device; peer average 2.35/device2022-04: 0 reports for this device; peer average 2.25/device2022-05: 0 reports for this device; peer average 2.27/device2022-06: 0 reports for this device; peer average 2.39/device2022-07: 0 reports for this device; peer average 2.19/device2022-08: 0 reports for this device; peer average 2.28/device2022-09: 0 reports for this device; peer average 2.32/device2022-10: 0 reports for this device; peer average 2.27/device2022-11: 0 reports for this device; peer average 2.34/device2022-12: 0 reports for this device; peer average 2.35/device2023-01: 0 reports for this device; peer average 2.55/device2023-02: 0 reports for this device; peer average 2.3/device2023-03: 0 reports for this device; peer average 2.53/device2023-04: 0 reports for this device; peer average 2.41/device2023-05: 0 reports for this device; peer average 2.29/device2023-06: 0 reports for this device; peer average 2.36/device2023-07: 0 reports for this device; peer average 2.17/device2023-08: 0 reports for this device; peer average 1.99/device2023-09: 0 reports for this device; peer average 1.99/device2023-10: 0 reports for this device; peer average 1.76/device2023-11: 0 reports for this device; peer average 1.69/device2023-12: 0 reports for this device; peer average 1.81/device2024-01: 0 reports for this device; peer average 1.81/device2024-02: 0 reports for this device; peer average 2.16/device2024-03: 0 reports for this device; peer average 1.98/device2024-04: 0 reports for this device; peer average 1.81/device2024-05: 0 reports for this device; peer average 2.06/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 1.9/device2024-09: 0 reports for this device; peer average 2.06/device2024-10: 0 reports for this device; peer average 1.86/device2024-11: 0 reports for this device; peer average 1.88/device2024-12: 0 reports for this device; peer average 1.63/device2025-01: 0 reports for this device; peer average 2.06/device2025-02: 0 reports for this device; peer average 1.59/device2025-03: 0 reports for this device; peer average 1.86/device2025-04: 0 reports for this device; peer average 1.87/device2025-05: 0 reports for this device; peer average 1.82/device2025-06: 0 reports for this device; peer average 1.9/device2025-07: 0 reports for this device; peer average 1.91/device2025-08: 0 reports for this device; peer average 1.81/device2025-09: 0 reports for this device; peer average 1.75/device2025-10: 0 reports for this device; peer average 1.78/device2025-11: 0 reports for this device; peer average 1.82/device2025-12: 0 reports for this device; peer average 1.92/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 1.69/device2026-03: 0 reports for this device; peer average 1.92/device2026-04: 0 reports for this device; peer average 1.95/device2026-05: 0 reports for this device; peer average 1.72/device2026-06: 0 reports for this device; peer average 1.78/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.07
2019-0202.66
2019-0303.07
2019-0402.88
2019-0502.22
2019-0601.9
2019-0701.87
2019-0802.23
2019-0902.48
2019-1002.75
2019-1102.29
2019-1202.62
2020-0103.07
2020-0202.62
2020-0303.32
2020-0402.39
2020-0502.27
2020-0602.2
2020-0702.62
2020-0802.14
2020-0902.73
2020-1002.66
2020-1102.45
2020-1202.46
2021-0102.62
2021-0202.17
2021-0302.15
2021-0402.18
2021-0502.07
2021-0602.61
2021-0702.46
2021-0802.51
2021-0902.57
2021-1002.33
2021-1102.17
2021-1202.44
2022-0102.22
2022-0202.1
2022-0302.35
2022-0402.25
2022-0502.27
2022-0602.39
2022-0702.19
2022-0802.28
2022-0902.32
2022-1002.27
2022-1102.34
2022-1202.35
2023-0102.55
2023-0202.3
2023-0302.53
2023-0402.41
2023-0502.29
2023-0602.36
2023-0702.17
2023-0801.99
2023-0901.99
2023-1001.76
2023-1101.69
2023-1201.81
2024-0101.81
2024-0202.16
2024-0301.98
2024-0401.81
2024-0502.06
2024-0601.92
2024-0701.77
2024-0801.9
2024-0902.06
2024-1001.86
2024-1101.88
2024-1201.63
2025-0102.06
2025-0201.59
2025-0301.86
2025-0401.87
2025-0501.82
2025-0601.9
2025-0701.91
2025-0801.81
2025-0901.75
2025-1001.78
2025-1101.82
2025-1201.92
2026-0102
2026-0201.69
2026-0301.92
2026-0401.95
2026-0501.72
2026-0601.78
This device (reports/month)Average device in KWY, LPH, LZO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K112019 — cites (transitively): K003363 (d1), K003429 (d1), K010243 (d1), K043537 (d1), K800207 (d1), K972961 (d1), K993438 (d1) — cited as predicate by K150007, K152084, K211866

K122099 — cites (transitively): K103431 (d1), K003363 (d2), K010839 (d2), K042249 (d2), K042344 (d2), K052026 (d2), K993438 (d2) — cited as predicate by K152084

K152084 — cites (transitively): K001733 (d1), K010367 (d1), K011623 (d1), K013350 (d1), K023680 (d1), K042959 (d1), K103431 (d1), K103479 (d1), K110290 (d1), K112019 (d1), K120578 (d1), K120924 (d1), K121665 (d1), K122099 (d1), K150007 (d1), K791125 (d1), K803126 (d1), K974054 (d1), K003363 (d2), K010839 (d2), K042249 (d2), K042344 (d2), K052026 (d2), K993438 (d2), K010757 (d2), K022077 (d2), K061434 (d2), K070885 (d2), K972228 (d2), K993601 (d2), K003429 (d2), K010243 (d2), K043537 (d2), K800207 (d2), K972961 (d2), K020572 (d2), K994366 (d2), K000306 (d2), K073337 (d2), K021911 (d2), K071535 (d2), K112115 (d2), K974685 (d2), K072857 (d3), K082792 (d3), K083558 (d3), K083762 (d3), K093944 (d3), K100412 (d3), K103189 (d3), K080885 (d4), K082844 (d4) — cited as predicate by K162127

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

Manufacturer compliance record — Corentec Co., Ltd

  • VAI 2024-08-29 Corentec Co., LTD · 1 citations
  • VAI 2024-08-29 Corentec Co., LTD · 1 citations
  • VAI 2019-10-31 Corentec Co., LTD · 0 citations
  • VAI 2019-10-31 Corentec Co., LTD · 0 citations
  • VAI 2015-04-09 Corentec Co., LTD · 7 citations
  • VAI 2015-04-09 Corentec Co., LTD · 7 citations
  • VAI 2014-01-16 Corentec Co., LTD · 7 citations
  • VAI 2014-01-16 Corentec Co., LTD · 7 citations