Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Match Point System

Model 804-06-351 · Materialise NV · DI 05420060366116

KWS — Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented · Class II · 21 CFR 888.3660

PHX — Shoulder Prosthesis, Reverse Configuration · Class II · 21 CFR 888.3660

QHE — Shoulder Arthroplasty Implantation System · Class II · 21 CFR 888.3660

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.

11232019-01: 0 reports for this device; peer average 1.82/device2019-02: 0 reports for this device; peer average 1.85/device2019-03: 0 reports for this device; peer average 1.75/device2019-04: 0 reports for this device; peer average 1.88/device2019-05: 0 reports for this device; peer average 2.1/device2019-06: 0 reports for this device; peer average 1.88/device2019-07: 0 reports for this device; peer average 1.68/device2019-08: 0 reports for this device; peer average 2.18/device2019-09: 0 reports for this device; peer average 1.67/device2019-10: 0 reports for this device; peer average 1.88/device2019-11: 0 reports for this device; peer average 1.72/device2019-12: 0 reports for this device; peer average 1.77/device2020-01: 0 reports for this device; peer average 1.96/device2020-02: 0 reports for this device; peer average 2.08/device2020-03: 0 reports for this device; peer average 2.19/device2020-04: 0 reports for this device; peer average 1.8/device2020-05: 0 reports for this device; peer average 1.66/device2020-06: 0 reports for this device; peer average 1.95/device2020-07: 0 reports for this device; peer average 2.24/device2020-08: 0 reports for this device; peer average 1.76/device2020-09: 0 reports for this device; peer average 1.96/device2020-10: 0 reports for this device; peer average 2.2/device2020-11: 0 reports for this device; peer average 1.9/device2020-12: 0 reports for this device; peer average 1.87/device2021-01: 0 reports for this device; peer average 2.2/device2021-02: 0 reports for this device; peer average 1.99/device2021-03: 0 reports for this device; peer average 2.15/device2021-04: 0 reports for this device; peer average 2.02/device2021-05: 0 reports for this device; peer average 2.02/device2021-06: 0 reports for this device; peer average 1.91/device2021-07: 0 reports for this device; peer average 2.06/device2021-08: 0 reports for this device; peer average 2.19/device2021-09: 0 reports for this device; peer average 1.97/device2021-10: 0 reports for this device; peer average 2.18/device2021-11: 0 reports for this device; peer average 2.13/device2021-12: 0 reports for this device; peer average 2.6/device2022-01: 0 reports for this device; peer average 2.65/device2022-02: 0 reports for this device; peer average 2.35/device2022-03: 0 reports for this device; peer average 2.49/device2022-04: 0 reports for this device; peer average 2.48/device2022-05: 0 reports for this device; peer average 2.13/device2022-06: 0 reports for this device; peer average 2.24/device2022-07: 0 reports for this device; peer average 2.2/device2022-08: 0 reports for this device; peer average 2.27/device2022-09: 0 reports for this device; peer average 2.04/device2022-10: 0 reports for this device; peer average 2.12/device2022-11: 0 reports for this device; peer average 2.16/device2022-12: 0 reports for this device; peer average 2.1/device2023-01: 0 reports for this device; peer average 1.85/device2023-02: 0 reports for this device; peer average 2.06/device2023-03: 0 reports for this device; peer average 2.05/device2023-04: 0 reports for this device; peer average 2.22/device2023-05: 0 reports for this device; peer average 2.12/device2023-06: 0 reports for this device; peer average 2.32/device2023-07: 0 reports for this device; peer average 2.11/device2023-08: 0 reports for this device; peer average 1.76/device2023-09: 0 reports for this device; peer average 1.59/device2023-10: 0 reports for this device; peer average 1.64/device2023-11: 0 reports for this device; peer average 1.7/device2023-12: 0 reports for this device; peer average 1.46/device2024-01: 0 reports for this device; peer average 1.9/device2024-02: 0 reports for this device; peer average 1.89/device2024-03: 0 reports for this device; peer average 1.73/device2024-04: 0 reports for this device; peer average 1.88/device2024-05: 0 reports for this device; peer average 1.73/device2024-06: 0 reports for this device; peer average 1.9/device2024-07: 0 reports for this device; peer average 1.63/device2024-08: 0 reports for this device; peer average 1.73/device2024-09: 0 reports for this device; peer average 1.75/device2024-10: 0 reports for this device; peer average 1.74/device2024-11: 0 reports for this device; peer average 1.64/device2024-12: 0 reports for this device; peer average 1.67/device2025-01: 0 reports for this device; peer average 1.74/device2025-02: 0 reports for this device; peer average 1.65/device2025-03: 0 reports for this device; peer average 1.94/device2025-04: 0 reports for this device; peer average 1.73/device2025-05: 0 reports for this device; peer average 1.83/device2025-06: 0 reports for this device; peer average 1.96/device2025-07: 0 reports for this device; peer average 1.8/device2025-08: 0 reports for this device; peer average 1.62/device2025-09: 0 reports for this device; peer average 1.52/device2025-10: 0 reports for this device; peer average 1.69/device2025-11: 0 reports for this device; peer average 1.74/device2025-12: 0 reports for this device; peer average 2.19/device2026-01: 0 reports for this device; peer average 1.93/device2026-02: 0 reports for this device; peer average 1.85/device2026-03: 0 reports for this device; peer average 1.8/device2026-04: 0 reports for this device; peer average 1.74/device2026-05: 0 reports for this device; peer average 1.8/device2026-06: 0 reports for this device; peer average 1.8/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.82
2019-0201.85
2019-0301.75
2019-0401.88
2019-0502.1
2019-0601.88
2019-0701.68
2019-0802.18
2019-0901.67
2019-1001.88
2019-1101.72
2019-1201.77
2020-0101.96
2020-0202.08
2020-0302.19
2020-0401.8
2020-0501.66
2020-0601.95
2020-0702.24
2020-0801.76
2020-0901.96
2020-1002.2
2020-1101.9
2020-1201.87
2021-0102.2
2021-0201.99
2021-0302.15
2021-0402.02
2021-0502.02
2021-0601.91
2021-0702.06
2021-0802.19
2021-0901.97
2021-1002.18
2021-1102.13
2021-1202.6
2022-0102.65
2022-0202.35
2022-0302.49
2022-0402.48
2022-0502.13
2022-0602.24
2022-0702.2
2022-0802.27
2022-0902.04
2022-1002.12
2022-1102.16
2022-1202.1
2023-0101.85
2023-0202.06
2023-0302.05
2023-0402.22
2023-0502.12
2023-0602.32
2023-0702.11
2023-0801.76
2023-0901.59
2023-1001.64
2023-1101.7
2023-1201.46
2024-0101.9
2024-0201.89
2024-0301.73
2024-0401.88
2024-0501.73
2024-0601.9
2024-0701.63
2024-0801.73
2024-0901.75
2024-1001.74
2024-1101.64
2024-1201.67
2025-0101.74
2025-0201.65
2025-0301.94
2025-0401.73
2025-0501.83
2025-0601.96
2025-0701.8
2025-0801.62
2025-0901.52
2025-1001.69
2025-1101.74
2025-1202.19
2026-0101.93
2026-0201.85
2026-0301.8
2026-0401.74
2026-0501.8
2026-0601.8
This device (reports/month)Average device in KWS, PHX, QHE (reports/device/month)

Regulatory clearances

  • K242813 SESE 2024-10-18 (k number procode)

Predicate lineage

K242813 — cites (transitively): K051075 (d1), K052472 (d1), K062250 (d1), K080402 (d1), K092122 (d1), K092873 (d1), K100448 (d1), K100858 (d1), K110598 (d1), K111629 (d1), K112438 (d1), K113254 (d1), K120174 (d1), K130050 (d1), K130642 (d1), K131559 (d1), K133349 (d1), K142139 (d1), K142413 (d1), K143256 (d1), K152047 (d1), K153602 (d1), K161189 (d1), K162024 (d1), K170893 (d1), K172054 (d1), K173717 (d1), K181999 (d1), K183077 (d1), K190286 (d1), K193560 (d1), K202716 (d1), K203694 (d1), K212569 (d1), K212737 (d1), K212933 (d1), K213387 (d1), K220452 (d1), K220792 (d1), K220847 (d1), K221467 (d1), K222427 (d1), K222592 (d1), K230315 (d1), K230572 (d1), K230831 (d1), K231112 (d1), K233408 (d1), K233481 (d1), K241143 (d1), K032126 (d2), K063578 (d2), K962082 (d2), K030259 (d2), K992525 (d2), K111863 (d2), K053274 (d2), K081016 (d2), K091751 (d2), K101263 (d2), K111212 (d2), K113523 (d2), K030710 (d2), K103007 (d2), K130895 (d2), K112144 (d2), K113413 (d2), K123982 (d2), K140904 (d2), K112069 (d2), K162800 (d2), K030941 (d2), K061439 (d2), K081059 (d2), K140478 (d2), K151293 (d2), K183039 (d2), K060692 (d2), K060694 (d2), K060716 (d2), K091196 (d2), K111596 (d2), K121183 (d2), K122698 (d2), K905786 (d2), K161742 (d2), K170748 (d2), K183696 (d2), K192855 (d2), K052906 (d2), K071379 (d2), K081620 (d2), K130048 (d2), K172351 (d2), K181611 (d2), K193373 (d2), K203108 (d2), K150583 (d2), K203026 (d2), K950651 (d2), K163397 (d2), K190911 (d2), K201905 (d2), K210717 (d2), K063569 (d2), K121543 (d2), K160975 (d2), K190588 (d2), K202611 (d2), K212800 (d2), K103419 (d2), K111379 (d2), K121220 (d2), K130129 (d2), K200171 (d2), K201315 (d2), K130390 (d2), K182039 (d2), K041066 (d2), K060988 (d3), K073331 (d3), K042021 (d3), K061454 (d3), K093430 (d3), K102670 (d3), K982981 (d3), K030047 (d3), K030055 (d3), K031454 (d3), K042989 (d3), K050124 (d3), K052996 (d3), K070369 (d3), K073449 (d3), K102795 (d3), K110555 (d3), K810120 (d3), K861114 (d3), K861433 (d3), K911685 (d3), K920639 (d3), K920640 (d3), K921181 (d3), K921277 (d3), K921301 (d3), K926107 (d3), K954417 (d3), K970501 (d3), K991990 (d3), K071147 (d3), K050316 (d3), K100142 (d3), K132285 (d3), K140082 (d3), K110708 (d3), K101342 (d3), K111902 (d3), K132636 (d3), K160001 (d3), K160555 (d3), K071090 (d3), K153722 (d3), K060704 (d3), K101996 (d3), K133834 (d3), K100741 (d3), K111061 (d3), K111735 (d3), K141006 (d3), K141990 (d3), K013991 (d3), K080642 (d3), K113069 (d3), K131353 (d3), K133378 (d3), K161120 (d3), K162068 (d3), K172371 (d3), K172634 (d3), K180612 (d3), K181742 (d3), K141934 (d3), K113121 (d3), K120121 (d3), K132239 (d3), K152754 (d3), K172502 (d3), K191746 (d3), K191963 (d3), K190521 (d3), K131112 (d3), K172456 (d3), K162455 (d3), K173900 (d3), K190290 (d3), K193372 (d3), K013042 (d3), K083439 (d3), K143552 (d3), K171858 (d3), K173388 (d3), K182516 (d3), K183194 (d3), K193226 (d3), K173073 (d3), K063470 (d4), K093533 (d4), K032396 (d4), K042037 (d4), K042051 (d4), K062995 (d4), K101336 (d4), K060209 (d4), K063081 (d4), K952928 (d4), K994392 (d4), K073468 (d4), K033260 (d4), K093552 (d4), K121443 (d4), K951987 (d4), K082120 (d4), K103208 (d4), K950594 (d4), K110847 (d4), K073714 (d4), K142923 (d4), K112898 (d4), K143374 (d4), K093599 (d4), K112193 (d4), K142778 (d4), K150488 (d4), K142863 (d4), K091508 (d4), K141395 (d4), K161863 (d4), K031729 (d4), K040267 (d4), K042883 (d4), K051146 (d4), K063423 (d4), K072221 (d4), K102975 (d4), K131298 (d4), K140063 (d4), K153595 (d4), K071881 (d4), K150307 (d4), K172326 (d4), K172210 (d4), K071032 (d4), K082358 (d5), K992065 (d5), K050327 (d5), K070364 (d5), K070399 (d5), K072020 (d5), K083116 (d5), K093644 (d5), K100048 (d5), K070479 (d5), K000575 (d5), K021891 (d5), K072154 (d5), K850766 (d5), K851213 (d5), K934765 (d5), K953490 (d5), K960094 (d5), K974093 (d5), K974095 (d5), K042515 (d5), K101499 (d5), K111711 (d5), K113482 (d5), K023096 (d5), K103251 (d5), K112389 (d5), K130126 (d5), K131129 (d5), K133039 (d5), K123814 (d5), K130759 (d5), K140071 (d5), K143393 (d5), K062113 (d5), K103835 (d5), K042993 (d5), K050539 (d5), K051380 (d5), K053514 (d5), K061521 (d5), K062037 (d5), K070095 (d5), K072575 (d5), K090763 (d5), K123166 (d5), K123486 (d5), K132624 (d5), K141056 (d5), K073102 (d6), K080528 (d6), K090103 (d6), K023211 (d6), K041825 (d6), K062654 (d6), K950521 (d6), K990598 (d6), K032295 (d6), K071071 (d6), K073325 (d6), K022204 (d6), K051229 (d6), K946236 (d6), K974556 (d6), K072160 (d6), K060874 (d6), K111097 (d6), K050897 (d6), K123122 (d6), K051977 (d6), K042067 (d6), K053340 (d6), K100391 (d6), K042871 (d7), K052888 (d7) — cited as predicate by K250921, K251558, K260802

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

Manufacturer compliance record — Materialise NV

Nothing in the loaded window.