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SurgiCase Planner

Model SurgiCase Knee Planner · Materialise NV · DI E314SURGICASEKNEEPLAN0

HSX — Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3520

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560

MBH — Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer · Class II · 21 CFR 888.3565

OIY — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive · Class II · 21 CFR 888.3560

OOG — Knee Arthroplasty Implantation System · Class II · 21 CFR 888.3560

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 2.24/device2019-02: 0 reports for this device; peer average 2/device2019-03: 0 reports for this device; peer average 1.67/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1.87/device2019-06: 0 reports for this device; peer average 2.06/device2019-07: 0 reports for this device; peer average 2.07/device2019-08: 0 reports for this device; peer average 2.35/device2019-09: 0 reports for this device; peer average 2.01/device2019-10: 0 reports for this device; peer average 2.46/device2019-11: 0 reports for this device; peer average 3.22/device2019-12: 0 reports for this device; peer average 2.44/device2020-01: 0 reports for this device; peer average 2.4/device2020-02: 0 reports for this device; peer average 2.54/device2020-03: 0 reports for this device; peer average 2.16/device2020-04: 0 reports for this device; peer average 1.98/device2020-05: 0 reports for this device; peer average 1.68/device2020-06: 0 reports for this device; peer average 1.99/device2020-07: 0 reports for this device; peer average 2.41/device2020-08: 0 reports for this device; peer average 2.45/device2020-09: 0 reports for this device; peer average 2.08/device2020-10: 0 reports for this device; peer average 2.56/device2020-11: 0 reports for this device; peer average 2.6/device2020-12: 0 reports for this device; peer average 2.56/device2021-01: 0 reports for this device; peer average 2.16/device2021-02: 0 reports for this device; peer average 2.19/device2021-03: 0 reports for this device; peer average 2.31/device2021-04: 0 reports for this device; peer average 2.2/device2021-05: 0 reports for this device; peer average 2.17/device2021-06: 0 reports for this device; peer average 2.11/device2021-07: 0 reports for this device; peer average 2.14/device2021-08: 0 reports for this device; peer average 1.82/device2021-09: 0 reports for this device; peer average 2.17/device2021-10: 0 reports for this device; peer average 1.88/device2021-11: 0 reports for this device; peer average 2.06/device2021-12: 0 reports for this device; peer average 2.19/device2022-01: 0 reports for this device; peer average 1.84/device2022-02: 0 reports for this device; peer average 2.13/device2022-03: 0 reports for this device; peer average 1.88/device2022-04: 0 reports for this device; peer average 1.96/device2022-05: 0 reports for this device; peer average 2.11/device2022-06: 0 reports for this device; peer average 1.87/device2022-07: 0 reports for this device; peer average 1.91/device2022-08: 0 reports for this device; peer average 1.91/device2022-09: 0 reports for this device; peer average 2.24/device2022-10: 0 reports for this device; peer average 1.96/device2022-11: 0 reports for this device; peer average 2.06/device2022-12: 0 reports for this device; peer average 1.72/device2023-01: 0 reports for this device; peer average 1.88/device2023-02: 0 reports for this device; peer average 2.01/device2023-03: 0 reports for this device; peer average 1.99/device2023-04: 0 reports for this device; peer average 2.01/device2023-05: 0 reports for this device; peer average 2.12/device2023-06: 0 reports for this device; peer average 2.04/device2023-07: 0 reports for this device; peer average 1.8/device2023-08: 0 reports for this device; peer average 1.57/device2023-09: 0 reports for this device; peer average 1.57/device2023-10: 0 reports for this device; peer average 1.48/device2023-11: 0 reports for this device; peer average 1.55/device2023-12: 0 reports for this device; peer average 1.55/device2024-01: 0 reports for this device; peer average 1.46/device2024-02: 0 reports for this device; peer average 1.59/device2024-03: 0 reports for this device; peer average 1.63/device2024-04: 0 reports for this device; peer average 1.52/device2024-05: 0 reports for this device; peer average 1.68/device2024-06: 0 reports for this device; peer average 1.75/device2024-07: 0 reports for this device; peer average 1.62/device2024-08: 0 reports for this device; peer average 2.03/device2024-09: 0 reports for this device; peer average 1.77/device2024-10: 0 reports for this device; peer average 1.79/device2024-11: 0 reports for this device; peer average 1.72/device2024-12: 0 reports for this device; peer average 1.8/device2025-01: 0 reports for this device; peer average 1.99/device2025-02: 0 reports for this device; peer average 1.64/device2025-03: 0 reports for this device; peer average 1.6/device2025-04: 0 reports for this device; peer average 1.51/device2025-05: 0 reports for this device; peer average 1.56/device2025-06: 0 reports for this device; peer average 1.61/device2025-07: 0 reports for this device; peer average 1.51/device2025-08: 0 reports for this device; peer average 1.51/device2025-09: 0 reports for this device; peer average 1.48/device2025-10: 0 reports for this device; peer average 1.36/device2025-11: 0 reports for this device; peer average 1.53/device2025-12: 0 reports for this device; peer average 1.56/device2026-01: 0 reports for this device; peer average 1.46/device2026-02: 0 reports for this device; peer average 1.43/device2026-03: 0 reports for this device; peer average 1.71/device2026-04: 0 reports for this device; peer average 1.57/device2026-05: 0 reports for this device; peer average 1.53/device2026-06: 0 reports for this device; peer average 1.52/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.24
2019-0202
2019-0301.67
2019-0402
2019-0501.87
2019-0602.06
2019-0702.07
2019-0802.35
2019-0902.01
2019-1002.46
2019-1103.22
2019-1202.44
2020-0102.4
2020-0202.54
2020-0302.16
2020-0401.98
2020-0501.68
2020-0601.99
2020-0702.41
2020-0802.45
2020-0902.08
2020-1002.56
2020-1102.6
2020-1202.56
2021-0102.16
2021-0202.19
2021-0302.31
2021-0402.2
2021-0502.17
2021-0602.11
2021-0702.14
2021-0801.82
2021-0902.17
2021-1001.88
2021-1102.06
2021-1202.19
2022-0101.84
2022-0202.13
2022-0301.88
2022-0401.96
2022-0502.11
2022-0601.87
2022-0701.91
2022-0801.91
2022-0902.24
2022-1001.96
2022-1102.06
2022-1201.72
2023-0101.88
2023-0202.01
2023-0301.99
2023-0402.01
2023-0502.12
2023-0602.04
2023-0701.8
2023-0801.57
2023-0901.57
2023-1001.48
2023-1101.55
2023-1201.55
2024-0101.46
2024-0201.59
2024-0301.63
2024-0401.52
2024-0501.68
2024-0601.75
2024-0701.62
2024-0802.03
2024-0901.77
2024-1001.79
2024-1101.72
2024-1201.8
2025-0101.99
2025-0201.64
2025-0301.6
2025-0401.51
2025-0501.56
2025-0601.61
2025-0701.51
2025-0801.51
2025-0901.48
2025-1001.36
2025-1101.53
2025-1201.56
2026-0101.46
2026-0201.43
2026-0301.71
2026-0401.57
2026-0501.53
2026-0601.52
This device (reports/month)Average device in HSX, JWH, MBH, OIY, OOG (reports/device/month)

Regulatory clearances

  • K202207 SESE 2020-10-02 (k number procode)
  • K173970 SESE 2018-07-06 (k number procode)
  • K172650 SESE 2017-11-20 (k number procode)

Predicate lineage

K150928 — cites (transitively): K001456 (d1), K102795 (d1), K102927 (d1), K110950 (d1), K133162 (d1), K143725 (d1), K932837 (d1), K945589 (d1), K954818 (d1), K962215 (d1), K983004 (d1), K073449 (d2), K093533 (d2), K030623 (d2), K033489 (d2), K073286 (d2), K070214 (d2), K121640 (d2), K121771 (d2), K122745 (d2), K023528 (d2), K100542 (d2), K933785 (d2), K082358 (d3), K101433 (d3), K120370 (d3), K040166 (d4), K082500 (d4), K943462 (d4), K961685 (d4), K103662 (d4), K101229 (d5), K091508 (d6), K093846 (d6) — cited as predicate by K162273, K170419

K162273 — cites (transitively): K150928 (d1), K001456 (d2), K102795 (d2), K102927 (d2), K110950 (d2), K133162 (d2), K143725 (d2), K932837 (d2), K945589 (d2), K954818 (d2), K962215 (d2), K983004 (d2), K073449 (d3), K093533 (d3), K030623 (d3), K033489 (d3), K073286 (d3), K070214 (d3), K121640 (d3), K121771 (d3), K122745 (d3), K023528 (d3), K100542 (d3), K933785 (d3), K082358 (d4), K101433 (d4), K120370 (d4), K040166 (d5), K082500 (d5), K943462 (d5), K961685 (d5), K103662 (d5), K101229 (d6), K091508 (d7), K093846 (d7) — cited as predicate by K172650, K173445

K172650 — cites (transitively): K112301 (d1), K161559 (d1), K162273 (d1), K033363 (d2), K093533 (d2), K110415 (d2), K003746 (d2), K110332 (d2), K120238 (d2), K150928 (d2), K082358 (d3), K101505 (d3), K001456 (d3), K102795 (d3), K102927 (d3), K110950 (d3), K133162 (d3), K143725 (d3), K932837 (d3), K945589 (d3), K954818 (d3), K962215 (d3), K983004 (d3), K062552 (d4), K071250 (d4), K073449 (d4), K030623 (d4), K033489 (d4), K073286 (d4), K070214 (d4), K121640 (d4), K121771 (d4), K122745 (d4), K023528 (d4), K100542 (d4), K933785 (d4), K101433 (d5), K120370 (d5), K040166 (d6), K082500 (d6), K943462 (d6), K961685 (d6), K103662 (d6), K101229 (d7), K091508 (d8), K093846 (d8) — cited as predicate by K173970

K173445 — cites (transitively): K110415 (d1), K140027 (d1), K161559 (d1), K162273 (d1), K082358 (d2), K113369 (d2), K113829 (d2), K121640 (d2), K122745 (d2), K003746 (d2), K110332 (d2), K120238 (d2), K150928 (d2), K060370 (d3), K073286 (d3), K933785 (d3), K936159 (d3), K960279 (d3), K102795 (d3), K111492 (d3), K101505 (d3), K001456 (d3), K102927 (d3), K110950 (d3), K133162 (d3), K143725 (d3), K932837 (d3), K945589 (d3), K954818 (d3), K962215 (d3), K983004 (d3), K062552 (d4), K071250 (d4), K073449 (d4), K093533 (d4), K030623 (d4), K033489 (d4), K070214 (d4), K121771 (d4), K023528 (d4), K100542 (d4), K101433 (d5), K120370 (d5), K040166 (d6), K082500 (d6), K943462 (d6), K961685 (d6), K103662 (d6), K101229 (d7), K091508 (d8), K093846 (d8) — cited as predicate by K173970, K221337

K173970 — cites (transitively): K110415 (d1), K172650 (d1), K173445 (d1), P010014 (d1), K082358 (d2), K112301 (d2), K161559 (d2), K162273 (d2), K140027 (d2), K033363 (d3), K093533 (d3), K113369 (d3), K113829 (d3), K121640 (d3), K122745 (d3), K003746 (d3), K110332 (d3), K120238 (d3), K150928 (d3), K060370 (d4), K073286 (d4), K933785 (d4), K936159 (d4), K960279 (d4), K102795 (d4), K111492 (d4), K101505 (d4), K001456 (d4), K102927 (d4), K110950 (d4), K133162 (d4), K143725 (d4), K932837 (d4), K945589 (d4), K954818 (d4), K962215 (d4), K983004 (d4), K062552 (d5), K071250 (d5), K073449 (d5), K030623 (d5), K033489 (d5), K070214 (d5), K121771 (d5), K023528 (d5), K100542 (d5), K101433 (d6), K120370 (d6), K040166 (d7), K082500 (d7), K943462 (d7), K961685 (d7), K103662 (d7), K101229 (d8) — cited as predicate by K202207, K211512

K202207 — cites (transitively): K173970 (d1), P010014 (d1), K110415 (d2), K172650 (d2), K173445 (d2), K082358 (d3), K112301 (d3), K161559 (d3), K162273 (d3), K140027 (d3), K033363 (d4), K093533 (d4), K113369 (d4), K113829 (d4), K121640 (d4), K122745 (d4), K003746 (d4), K110332 (d4), K120238 (d4), K150928 (d4), K060370 (d5), K073286 (d5), K933785 (d5), K936159 (d5), K960279 (d5), K102795 (d5), K111492 (d5), K101505 (d5), K001456 (d5), K102927 (d5), K110950 (d5), K133162 (d5), K143725 (d5), K932837 (d5), K945589 (d5), K954818 (d5), K962215 (d5), K983004 (d5), K062552 (d6), K071250 (d6), K073449 (d6), K030623 (d6), K033489 (d6), K070214 (d6), K121771 (d6), K023528 (d6), K100542 (d6), K101433 (d7), K120370 (d7), K040166 (d8), K082500 (d8), K943462 (d8), K961685 (d8), K103662 (d8) — cited as predicate by K221337, K251554, K253793

K251554 — cites (transitively): K202207 (d1), K221337 (d1), K173970 (d2), P010014 (d2), K173445 (d2), K110415 (d3), K140027 (d3), K161559 (d3), K162273 (d3), K172650 (d3), K082358 (d4), K113369 (d4), K113829 (d4), K121640 (d4), K122745 (d4), K003746 (d4), K110332 (d4), K120238 (d4), K150928 (d4), K112301 (d4), K033363 (d5), K093533 (d5), K060370 (d5), K073286 (d5), K933785 (d5), K936159 (d5), K960279 (d5), K102795 (d5), K111492 (d5), K101505 (d5), K001456 (d5), K102927 (d5), K110950 (d5), K133162 (d5), K143725 (d5), K932837 (d5), K945589 (d5), K954818 (d5), K962215 (d5), K983004 (d5), K062552 (d6), K071250 (d6), K073449 (d6), K030623 (d6), K033489 (d6), K070214 (d6), K121771 (d6), K023528 (d6), K100542 (d6), K101433 (d7), K120370 (d7), K040166 (d8), K082500 (d8), K943462 (d8), K961685 (d8), K103662 (d8) — cited as predicate by K253793

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

Manufacturer compliance record — Materialise NV

Nothing in the loaded window.