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MectaPlug PE II

Model 01.33.201 · Medacta International SA · DI 07630345710963

JDK — Prosthesis, Hip, Cement Restrictor · Class II · 21 CFR 878.3300

UDILibrary device dossier · generated 2026-09-11 · 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.

12232019-02: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 3/device2021-07: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1/device0207081006070710020410010304060705
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0701
2019-0801
2019-1003
2021-0603
2021-0702
2022-0701
2023-1002
2024-0202
2024-0402
2024-1001
2025-0101
2025-0302
2025-0401
2025-0601
2025-0701
2026-0501
This device (reports/month)Average device in JDK (reports/device/month)

Regulatory clearances

  • K210062 SESE 2021-04-08 (k number procode)

Predicate lineage

K210062 — cites (transitively): K021765 (d1), K192827 (d1), K791125 (d1), K800144 (d1)

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