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AMIStem-P Collared

Model 01.18.436 · Medacta International SA · DI 07630040720250

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

LZY — Prosthesis, Hip, Hemi-, Femoral, Metal Ball · Class II · 21 CFR 888.3360

MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353

UDILibrary device dossier · generated 2026-09-07 · 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 (6)

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.

Injury: 6

12232019-01: 0 reports for this device; peer average 2.83/device2019-02: 0 reports for this device; peer average 2.48/device2019-03: 0 reports for this device; peer average 2.85/device2019-04: 0 reports for this device; peer average 2.71/device2019-05: 0 reports for this device; peer average 2.1/device2019-06: 0 reports for this device; peer average 1.8/device2019-07: 0 reports for this device; peer average 1.77/device2019-08: 0 reports for this device; peer average 2.12/device2019-09: 0 reports for this device; peer average 2.3/device2019-10: 0 reports for this device; peer average 2.53/device2019-11: 0 reports for this device; peer average 2.17/device2019-12: 0 reports for this device; peer average 2.44/device2020-01: 0 reports for this device; peer average 2.85/device2020-02: 0 reports for this device; peer average 2.44/device2020-03: 0 reports for this device; peer average 3.1/device2020-04: 0 reports for this device; peer average 2.27/device2020-05: 1 reports for this device; peer average 2.15/device2020-06: 0 reports for this device; peer average 2.09/device2020-07: 2 reports for this device; peer average 2.48/device2020-08: 0 reports for this device; peer average 2.04/device2020-09: 0 reports for this device; peer average 2.55/device2020-10: 0 reports for this device; peer average 2.49/device2020-11: 0 reports for this device; peer average 2.32/device2020-12: 0 reports for this device; peer average 2.3/device2021-01: 0 reports for this device; peer average 2.46/device2021-02: 0 reports for this device; peer average 2.05/device2021-03: 0 reports for this device; peer average 2.03/device2021-04: 0 reports for this device; peer average 2.07/device2021-05: 0 reports for this device; peer average 1.98/device2021-06: 0 reports for this device; peer average 2.45/device2021-07: 0 reports for this device; peer average 2.32/device2021-08: 0 reports for this device; peer average 2.35/device2021-09: 0 reports for this device; peer average 2.44/device2021-10: 0 reports for this device; peer average 2.22/device2021-11: 0 reports for this device; peer average 2.06/device2021-12: 0 reports for this device; peer average 2.28/device2022-01: 0 reports for this device; peer average 2.11/device2022-02: 0 reports for this device; peer average 2.01/device2022-03: 0 reports for this device; peer average 2.2/device2022-04: 0 reports for this device; peer average 2.14/device2022-05: 2 reports for this device; peer average 2.18/device2022-06: 0 reports for this device; peer average 2.26/device2022-07: 0 reports for this device; peer average 2.08/device2022-08: 0 reports for this device; peer average 2.17/device2022-09: 0 reports for this device; peer average 2.22/device2022-10: 0 reports for this device; peer average 2.16/device2022-11: 0 reports for this device; peer average 2.23/device2022-12: 0 reports for this device; peer average 2.17/device2023-01: 0 reports for this device; peer average 2.42/device2023-02: 0 reports for this device; peer average 2.18/device2023-03: 0 reports for this device; peer average 2.38/device2023-04: 0 reports for this device; peer average 2.31/device2023-05: 0 reports for this device; peer average 2.19/device2023-06: 0 reports for this device; peer average 2.29/device2023-07: 0 reports for this device; peer average 2.13/device2023-08: 0 reports for this device; peer average 1.94/device2023-09: 0 reports for this device; peer average 1.96/device2023-10: 0 reports for this device; peer average 1.7/device2023-11: 0 reports for this device; peer average 1.63/device2023-12: 0 reports for this device; peer average 1.74/device2024-01: 1 reports for this device; peer average 1.74/device2024-02: 0 reports for this device; peer average 2.09/device2024-03: 0 reports for this device; peer average 1.96/device2024-04: 0 reports for this device; peer average 1.78/device2024-05: 0 reports for this device; peer average 2.08/device2024-06: 0 reports for this device; peer average 1.91/device2024-07: 0 reports for this device; peer average 1.72/device2024-08: 0 reports for this device; peer average 1.91/device2024-09: 0 reports for this device; peer average 2.02/device2024-10: 0 reports for this device; peer average 1.83/device2024-11: 0 reports for this device; peer average 1.8/device2024-12: 0 reports for this device; peer average 1.6/device2025-01: 0 reports for this device; peer average 1.99/device2025-02: 0 reports for this device; peer average 1.56/device2025-03: 0 reports for this device; peer average 1.83/device2025-04: 0 reports for this device; peer average 1.84/device2025-05: 0 reports for this device; peer average 1.76/device2025-06: 0 reports for this device; peer average 1.88/device2025-07: 0 reports for this device; peer average 1.86/device2025-08: 0 reports for this device; peer average 1.75/device2025-09: 0 reports for this device; peer average 1.71/device2025-10: 0 reports for this device; peer average 1.74/device2025-11: 0 reports for this device; peer average 1.8/device2025-12: 0 reports for this device; peer average 1.89/device2026-01: 0 reports for this device; peer average 1.95/device2026-02: 0 reports for this device; peer average 1.66/device2026-03: 0 reports for this device; peer average 1.91/device2026-04: 0 reports for this device; peer average 1.9/device2026-05: 0 reports for this device; peer average 1.68/device2026-06: 0 reports for this device; peer average 1.76/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.83
2019-0202.48
2019-0302.85
2019-0402.71
2019-0502.1
2019-0601.8
2019-0701.77
2019-0802.12
2019-0902.3
2019-1002.53
2019-1102.17
2019-1202.44
2020-0102.85
2020-0202.44
2020-0303.1
2020-0402.27
2020-0512.15
2020-0602.09
2020-0722.48
2020-0802.04
2020-0902.55
2020-1002.49
2020-1102.32
2020-1202.3
2021-0102.46
2021-0202.05
2021-0302.03
2021-0402.07
2021-0501.98
2021-0602.45
2021-0702.32
2021-0802.35
2021-0902.44
2021-1002.22
2021-1102.06
2021-1202.28
2022-0102.11
2022-0202.01
2022-0302.2
2022-0402.14
2022-0522.18
2022-0602.26
2022-0702.08
2022-0802.17
2022-0902.22
2022-1002.16
2022-1102.23
2022-1202.17
2023-0102.42
2023-0202.18
2023-0302.38
2023-0402.31
2023-0502.19
2023-0602.29
2023-0702.13
2023-0801.94
2023-0901.96
2023-1001.7
2023-1101.63
2023-1201.74
2024-0111.74
2024-0202.09
2024-0301.96
2024-0401.78
2024-0502.08
2024-0601.91
2024-0701.72
2024-0801.91
2024-0902.02
2024-1001.83
2024-1101.8
2024-1201.6
2025-0101.99
2025-0201.56
2025-0301.83
2025-0401.84
2025-0501.76
2025-0601.88
2025-0701.86
2025-0801.75
2025-0901.71
2025-1001.74
2025-1101.8
2025-1201.89
2026-0101.95
2026-0201.66
2026-0301.91
2026-0401.9
2026-0501.68
2026-0601.76
This device (reports/month)Average device in KWY, LPH, LZO, LZY, MEH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K173794 — cites (transitively): K093944 (d1), K103189 (d1), K121011 (d1), K161635 (d1), K072857 (d2), K073337 (d2), K080885 (d2), K082792 (d2), K083558 (d2), K123392 (d2), K042992 (d3) — cited as predicate by K181254, K192126, K193433, K201673, K202730, K203041, K250450, K251166

K250450 — cites (transitively): K082792 (d1), K093944 (d1), K103352 (d1), K103721 (d1), K121011 (d1), K122641 (d1), K122911 (d1), K132879 (d1), K161635 (d1), K170845 (d1), K173794 (d1), K181254 (d1), K181693 (d1), K192126 (d1), K192352 (d1), K192827 (d1), K201673 (d1), K202730 (d1), K203041 (d1), K210263 (d1), K230011 (d1), K072857 (d2), K073337 (d2), K080885 (d2), K003758 (d2), K050262 (d2), K083558 (d2), K092265 (d2), K993082 (d2), K070756 (d2), K100555 (d2), K033338 (d2), K103189 (d2), K123392 (d2), K111145 (d2), K112115 (d2), K123604 (d2), K131518 (d2), K151531 (d2), K083116 (d2), K091967 (d2), K143453 (d2), K171966 (d2), K191216 (d2), K071723 (d2), K083312 (d2), K111046 (d2), K181963 (d2), K183582 (d2), K200391 (d2), K003666 (d3), K030733 (d3), K080584 (d3), K925866 (d3), K992235 (d3), K014072 (d3), K050966 (d3), K082468 (d3), K982447 (d3), K021911 (d3), K030923 (d3), K061253 (d3), K071718 (d3), K072557 (d3), K990135 (d3), K994415 (d3), K062408 (d3), K896580 (d3), K071535 (d3), K083762 (d3), K100412 (d3), K042992 (d3), K103479 (d3), K120578 (d3), K082996 (d3), K093549 (d3), K131458 (d3), K100391 (d3), K112898 (d3), K141395 (d3), K170149 (d3), K072326 (d3), K090707 (d3), K110783 (d3), K151140 (d3), K173148 (d3), P950002 (d3), P950019 (d3), P960025 (d3), K072963 (d3), K102423 (d3), K121874 (d3), K132959 (d3), K163687 (d3), K182624 (d3), K042871 (d4), K052888 (d4), K053340 (d4), K082844 (d4), K053508 (d4), K062083 (d4), K072253 (d4), K081888 (d4), K083661 (d4), K090816 (d4), K092162 (d4), K093704 (d4), K100516 (d4), K021891 (d4), K070369 (d4), K072154 (d4), K102975 (d4), K850766 (d4), K851213 (d4), K934765 (d4), K953490 (d4), K960094 (d4), K974093 (d4), K974095 (d4), K020572 (d4), K994366 (d4), K093235 (d4), K103233 (d4), K121096 (d4), K033960 (d4), K072336 (d4), K090988 (d4), K102437 (d4), K102896 (d4), K130299 (d4), K073351 (d4), K081917 (d4), K091088 (d4), P000028 (d4), P980048 (d4), K153355 (d4), K172218 (d4), K180815 (d4), K002379 (d5), K070479 (d5), K072020 (d5), K093644 (d5), K043405 (d5), K052210 (d5), K071795 (d5), K101720 (d5), K120063 (d5), K002552 (d5), K896048 (d5), K101279 (d5), K103480 (d5), K130884 (d5), K141074 (d5), K103576 (d5), K151913 (d5), K023190 (d5), K162483 (d5), K003437 (d6), K063762 (d6), K080575 (d6), K083327 (d6), K030534 (d6), K071964 (d6), K992762 (d6), K021656 (d6), K093982 (d6), K062393 (d6), K110834 (d6), K112930 (d6), K131634 (d6), K142006 (d6), K151749 (d6), K051673 (d7), K042956 (d7), K103785 (d7), K082506 (d7), K133424 (d7), K140912 (d7), K143401 (d7), K042328 (d8), K050297 (d8), K120579 (d8), K130901 (d8)

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