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Bipolar Heads

Model 25060.2247 · Medacta International SA · DI 07630030843433

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

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.

11222019-01: 0 reports for this device; peer average 1.65/device2019-02: 0 reports for this device; peer average 1.49/device2019-03: 0 reports for this device; peer average 1.73/device2019-04: 0 reports for this device; peer average 1.87/device2019-05: 0 reports for this device; peer average 1.55/device2019-06: 0 reports for this device; peer average 1.25/device2019-07: 0 reports for this device; peer average 1.43/device2019-08: 0 reports for this device; peer average 1.45/device2019-09: 0 reports for this device; peer average 1.41/device2019-10: 0 reports for this device; peer average 1.5/device2019-11: 0 reports for this device; peer average 1.35/device2019-12: 0 reports for this device; peer average 1.42/device2020-01: 0 reports for this device; peer average 1.68/device2020-02: 0 reports for this device; peer average 1.39/device2020-03: 0 reports for this device; peer average 1.51/device2020-04: 0 reports for this device; peer average 1.46/device2020-05: 0 reports for this device; peer average 1.45/device2020-06: 0 reports for this device; peer average 1.45/device2020-07: 0 reports for this device; peer average 1.47/device2020-08: 0 reports for this device; peer average 1.29/device2020-09: 0 reports for this device; peer average 1.42/device2020-10: 0 reports for this device; peer average 1.32/device2020-11: 0 reports for this device; peer average 1.43/device2020-12: 0 reports for this device; peer average 1.6/device2021-01: 0 reports for this device; peer average 1.69/device2021-02: 0 reports for this device; peer average 1.36/device2021-03: 0 reports for this device; peer average 1.37/device2021-04: 0 reports for this device; peer average 1.32/device2021-05: 0 reports for this device; peer average 1.31/device2021-06: 0 reports for this device; peer average 1.4/device2021-07: 0 reports for this device; peer average 1.36/device2021-08: 0 reports for this device; peer average 1.34/device2021-09: 0 reports for this device; peer average 1.44/device2021-10: 0 reports for this device; peer average 1.42/device2021-11: 0 reports for this device; peer average 1.32/device2021-12: 0 reports for this device; peer average 1.41/device2022-01: 0 reports for this device; peer average 1.31/device2022-02: 0 reports for this device; peer average 1.3/device2022-03: 0 reports for this device; peer average 1.32/device2022-04: 0 reports for this device; peer average 1.44/device2022-05: 0 reports for this device; peer average 1.44/device2022-06: 0 reports for this device; peer average 1.47/device2022-07: 0 reports for this device; peer average 1.33/device2022-08: 0 reports for this device; peer average 1.46/device2022-09: 0 reports for this device; peer average 1.49/device2022-10: 0 reports for this device; peer average 1.36/device2022-11: 0 reports for this device; peer average 1.36/device2022-12: 0 reports for this device; peer average 1.34/device2023-01: 0 reports for this device; peer average 2.1/device2023-02: 0 reports for this device; peer average 1.52/device2023-03: 0 reports for this device; peer average 1.41/device2023-04: 0 reports for this device; peer average 1.39/device2023-05: 0 reports for this device; peer average 1.35/device2023-06: 0 reports for this device; peer average 1.33/device2023-07: 0 reports for this device; peer average 1.36/device2023-08: 0 reports for this device; peer average 1.29/device2023-09: 0 reports for this device; peer average 1.31/device2023-10: 0 reports for this device; peer average 1.27/device2023-11: 0 reports for this device; peer average 1.18/device2023-12: 0 reports for this device; peer average 1.18/device2024-01: 0 reports for this device; peer average 1.34/device2024-02: 0 reports for this device; peer average 1.3/device2024-03: 0 reports for this device; peer average 1.48/device2024-04: 0 reports for this device; peer average 1.13/device2024-05: 0 reports for this device; peer average 1.17/device2024-06: 0 reports for this device; peer average 1.28/device2024-07: 0 reports for this device; peer average 1.24/device2024-08: 0 reports for this device; peer average 1.23/device2024-09: 0 reports for this device; peer average 1.3/device2024-10: 0 reports for this device; peer average 1.39/device2024-11: 0 reports for this device; peer average 1.32/device2024-12: 0 reports for this device; peer average 1.27/device2025-01: 0 reports for this device; peer average 1.49/device2025-02: 0 reports for this device; peer average 1.27/device2025-03: 0 reports for this device; peer average 1.75/device2025-04: 0 reports for this device; peer average 1.61/device2025-05: 0 reports for this device; peer average 1.33/device2025-06: 0 reports for this device; peer average 1.54/device2025-07: 0 reports for this device; peer average 1.64/device2025-08: 0 reports for this device; peer average 1.36/device2025-09: 0 reports for this device; peer average 1.42/device2025-10: 0 reports for this device; peer average 1.56/device2025-11: 0 reports for this device; peer average 1.51/device2025-12: 0 reports for this device; peer average 1.54/device2026-01: 0 reports for this device; peer average 1.65/device2026-02: 0 reports for this device; peer average 1.3/device2026-03: 0 reports for this device; peer average 1.53/device2026-04: 0 reports for this device; peer average 1.59/device2026-05: 0 reports for this device; peer average 1.27/device2026-06: 0 reports for this device; peer average 1.32/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.65
2019-0201.49
2019-0301.73
2019-0401.87
2019-0501.55
2019-0601.25
2019-0701.43
2019-0801.45
2019-0901.41
2019-1001.5
2019-1101.35
2019-1201.42
2020-0101.68
2020-0201.39
2020-0301.51
2020-0401.46
2020-0501.45
2020-0601.45
2020-0701.47
2020-0801.29
2020-0901.42
2020-1001.32
2020-1101.43
2020-1201.6
2021-0101.69
2021-0201.36
2021-0301.37
2021-0401.32
2021-0501.31
2021-0601.4
2021-0701.36
2021-0801.34
2021-0901.44
2021-1001.42
2021-1101.32
2021-1201.41
2022-0101.31
2022-0201.3
2022-0301.32
2022-0401.44
2022-0501.44
2022-0601.47
2022-0701.33
2022-0801.46
2022-0901.49
2022-1001.36
2022-1101.36
2022-1201.34
2023-0102.1
2023-0201.52
2023-0301.41
2023-0401.39
2023-0501.35
2023-0601.33
2023-0701.36
2023-0801.29
2023-0901.31
2023-1001.27
2023-1101.18
2023-1201.18
2024-0101.34
2024-0201.3
2024-0301.48
2024-0401.13
2024-0501.17
2024-0601.28
2024-0701.24
2024-0801.23
2024-0901.3
2024-1001.39
2024-1101.32
2024-1201.27
2025-0101.49
2025-0201.27
2025-0301.75
2025-0401.61
2025-0501.33
2025-0601.54
2025-0701.64
2025-0801.36
2025-0901.42
2025-1001.56
2025-1101.51
2025-1201.54
2026-0101.65
2026-0201.3
2026-0301.53
2026-0401.59
2026-0501.27
2026-0601.32
This device (reports/month)Average device in KWY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K091967 — cites (transitively): K014072 (d1), K050966 (d1), K072857 (d1), K073337 (d1), K082468 (d1), K082792 (d1), K982447 (d1) — cited as predicate by K132539, K133370, K171595, K181254, K201673, K202730, K203041, K220405, K241461, K241767

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

Manufacturer compliance record — Medacta International SA

  • VAI 2024-11-19 Medacta International, SA · 1 citations
  • VAI 2024-11-19 Medacta International SA · 0 citations
  • VAI 2024-11-19 Medacta International, SA · 1 citations
  • VAI 2024-11-19 Medacta International SA · 0 citations
  • VAI 2017-06-19 Medacta International SA · 0 citations
  • VAI 2017-06-19 Medacta International SA · 0 citations
  • VAI 2017-02-17 Parcus Medical, LLC · 2 citations
  • OAI 2015-02-05 Medacta International SA · 8 citations
  • OAI 2015-02-05 Medacta International SA · 8 citations
  • VAI 2013-08-16 Parcus Medical, LLC · 1 citations
  • VAI 2010-01-28 Medacta International SA · 0 citations
  • VAI 2010-01-28 Medacta International SA · 0 citations