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LINK Endo-Model EVO Knee System

Model 15-3966/05 · WALDEMAR LINK GmbH & Co. KG · DI 04026575082346

KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3510

UDILibrary device dossier · generated 2026-09-14 · 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.

12452019-01: 0 reports for this device; peer average 2.1/device2019-02: 0 reports for this device; peer average 2.97/device2019-03: 0 reports for this device; peer average 1.73/device2019-04: 0 reports for this device; peer average 1.78/device2019-05: 0 reports for this device; peer average 1.79/device2019-06: 0 reports for this device; peer average 1.75/device2019-07: 0 reports for this device; peer average 2.55/device2019-08: 0 reports for this device; peer average 2.63/device2019-09: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1.55/device2019-11: 0 reports for this device; peer average 1.56/device2019-12: 0 reports for this device; peer average 2.69/device2020-01: 0 reports for this device; peer average 2.08/device2020-02: 0 reports for this device; peer average 2.42/device2020-03: 0 reports for this device; peer average 2.7/device2020-04: 0 reports for this device; peer average 3.18/device2020-05: 0 reports for this device; peer average 4.8/device2020-06: 0 reports for this device; peer average 1.82/device2020-07: 0 reports for this device; peer average 2.11/device2020-08: 0 reports for this device; peer average 1.57/device2020-09: 0 reports for this device; peer average 2.16/device2020-10: 0 reports for this device; peer average 3.15/device2020-11: 0 reports for this device; peer average 2.29/device2020-12: 0 reports for this device; peer average 1.84/device2021-01: 0 reports for this device; peer average 1.5/device2021-02: 0 reports for this device; peer average 1.81/device2021-03: 0 reports for this device; peer average 2.21/device2021-04: 0 reports for this device; peer average 2.11/device2021-05: 0 reports for this device; peer average 2.69/device2021-06: 0 reports for this device; peer average 2.32/device2021-07: 0 reports for this device; peer average 3.29/device2021-08: 0 reports for this device; peer average 2.48/device2021-09: 0 reports for this device; peer average 3.02/device2021-10: 0 reports for this device; peer average 2.18/device2021-11: 0 reports for this device; peer average 3.38/device2021-12: 0 reports for this device; peer average 3.27/device2022-01: 0 reports for this device; peer average 2.9/device2022-02: 0 reports for this device; peer average 4.12/device2022-03: 0 reports for this device; peer average 1.79/device2022-04: 0 reports for this device; peer average 2.91/device2022-05: 0 reports for this device; peer average 2.55/device2022-06: 0 reports for this device; peer average 2.5/device2022-07: 0 reports for this device; peer average 2.18/device2022-08: 0 reports for this device; peer average 2.56/device2022-09: 0 reports for this device; peer average 2.05/device2022-10: 0 reports for this device; peer average 2.27/device2022-11: 0 reports for this device; peer average 3.06/device2022-12: 0 reports for this device; peer average 2.93/device2023-01: 0 reports for this device; peer average 1.87/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 2.33/device2023-04: 0 reports for this device; peer average 1.9/device2023-05: 0 reports for this device; peer average 2.82/device2023-06: 0 reports for this device; peer average 2.77/device2023-07: 0 reports for this device; peer average 2.34/device2023-08: 0 reports for this device; peer average 2.62/device2023-09: 0 reports for this device; peer average 2.78/device2023-10: 0 reports for this device; peer average 1.38/device2023-11: 0 reports for this device; peer average 1.6/device2023-12: 0 reports for this device; peer average 1.55/device2024-01: 0 reports for this device; peer average 2.13/device2024-02: 0 reports for this device; peer average 1.74/device2024-03: 0 reports for this device; peer average 1.96/device2024-04: 0 reports for this device; peer average 1.53/device2024-05: 0 reports for this device; peer average 2.38/device2024-06: 0 reports for this device; peer average 1.59/device2024-07: 0 reports for this device; peer average 1.79/device2024-08: 0 reports for this device; peer average 1.49/device2024-09: 0 reports for this device; peer average 2.93/device2024-10: 0 reports for this device; peer average 2.15/device2024-11: 0 reports for this device; peer average 1.78/device2024-12: 0 reports for this device; peer average 1.63/device2025-01: 0 reports for this device; peer average 1.53/device2025-02: 0 reports for this device; peer average 1.69/device2025-03: 0 reports for this device; peer average 1.56/device2025-04: 0 reports for this device; peer average 2.03/device2025-05: 0 reports for this device; peer average 1.92/device2025-06: 0 reports for this device; peer average 1.9/device2025-07: 0 reports for this device; peer average 1.87/device2025-08: 0 reports for this device; peer average 2.33/device2025-09: 0 reports for this device; peer average 2.33/device2025-10: 0 reports for this device; peer average 1.96/device2025-11: 0 reports for this device; peer average 2.64/device2025-12: 0 reports for this device; peer average 2.4/device2026-01: 0 reports for this device; peer average 3.33/device2026-02: 0 reports for this device; peer average 2.24/device2026-03: 0 reports for this device; peer average 3.04/device2026-04: 0 reports for this device; peer average 1.72/device2026-05: 0 reports for this device; peer average 2.57/device2026-06: 0 reports for this device; peer average 1.67/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.1
2019-0202.97
2019-0301.73
2019-0401.78
2019-0501.79
2019-0601.75
2019-0702.55
2019-0802.63
2019-0902
2019-1001.55
2019-1101.56
2019-1202.69
2020-0102.08
2020-0202.42
2020-0302.7
2020-0403.18
2020-0504.8
2020-0601.82
2020-0702.11
2020-0801.57
2020-0902.16
2020-1003.15
2020-1102.29
2020-1201.84
2021-0101.5
2021-0201.81
2021-0302.21
2021-0402.11
2021-0502.69
2021-0602.32
2021-0703.29
2021-0802.48
2021-0903.02
2021-1002.18
2021-1103.38
2021-1203.27
2022-0102.9
2022-0204.12
2022-0301.79
2022-0402.91
2022-0502.55
2022-0602.5
2022-0702.18
2022-0802.56
2022-0902.05
2022-1002.27
2022-1103.06
2022-1202.93
2023-0101.87
2023-0202
2023-0302.33
2023-0401.9
2023-0502.82
2023-0602.77
2023-0702.34
2023-0802.62
2023-0902.78
2023-1001.38
2023-1101.6
2023-1201.55
2024-0102.13
2024-0201.74
2024-0301.96
2024-0401.53
2024-0502.38
2024-0601.59
2024-0701.79
2024-0801.49
2024-0902.93
2024-1002.15
2024-1101.78
2024-1201.63
2025-0101.53
2025-0201.69
2025-0301.56
2025-0402.03
2025-0501.92
2025-0601.9
2025-0701.87
2025-0802.33
2025-0902.33
2025-1001.96
2025-1102.64
2025-1202.4
2026-0103.33
2026-0202.24
2026-0303.04
2026-0401.72
2026-0502.57
2026-0601.67
This device (reports/month)Average device in KRO (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K220628 — cites (transitively): K143179 (d1), K151008 (d1), K152431 (d1), K200113 (d1), K201364 (d1), K202924 (d1), K212742 (d1), K013385 (d2), K023087 (d2), K142187 (d2), K102896 (d2), K153595 (d2), K103517 (d2), K041106 (d2), K043440 (d2), K072531 (d2), K182872 (d2), K951987 (d2), K953274 (d2), K040487 (d3), K040630 (d3), K053340 (d3), K098078 (d3), K982302 (d3), K955296 (d3), K102975 (d3), K143393 (d3), K122239 (d3), K923277 (d3), K933539 (d3), K070479 (d4), K933593 (d4), K964008 (d4), K100391 (d4), K123486 (d4), K132624 (d4), K042871 (d5), K052888 (d5), K072160 (d5), K031729 (d5), K040267 (d5), K042883 (d5), K042993 (d5), K051146 (d5), K051380 (d5), K051977 (d5), K053514 (d5), K061521 (d5), K072221 (d5), K072575 (d5), K123166 (d5), K050539 (d6), K063423 (d6), K974556 (d6)

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

Manufacturer compliance record — WALDEMAR LINK GmbH & Co. KG

  • NAI 2026-02-19 Waldemar Link GmbH & Co. KG (Mfg Site) · 0 citations
  • VAI 2023-05-11 Waldemar Link GmbH & Co. KG (Mfg Site) · 5 citations
  • VAI 2015-01-22 Waldemar Link GmbH & Co. KG (Mfg Site) · 3 citations
  • NAI 2012-07-26 Waldemar Link GmbH & Co. KG (Mfg Site) · 0 citations
  • VAI 2010-09-16 Waldemar Link GmbH & Co. KG (Mfg Site) · 2 citations