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Veritas Reverse Total Shoulder

Model 1500-9001-P01 · Restor3d, Inc. · DI 00840097516004

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.

12342019-01: 0 reports for this device; peer average 2.1/device2019-02: 0 reports for this device; peer average 2.32/device2019-03: 0 reports for this device; peer average 1.9/device2019-04: 0 reports for this device; peer average 2.37/device2019-05: 0 reports for this device; peer average 2.59/device2019-06: 0 reports for this device; peer average 1.9/device2019-07: 0 reports for this device; peer average 2.22/device2019-08: 0 reports for this device; peer average 2.61/device2019-09: 0 reports for this device; peer average 1.98/device2019-10: 0 reports for this device; peer average 2.02/device2019-11: 0 reports for this device; peer average 1.86/device2019-12: 0 reports for this device; peer average 1.81/device2020-01: 0 reports for this device; peer average 2.03/device2020-02: 0 reports for this device; peer average 1.99/device2020-03: 0 reports for this device; peer average 2.77/device2020-04: 0 reports for this device; peer average 1.94/device2020-05: 0 reports for this device; peer average 1.92/device2020-06: 0 reports for this device; peer average 2.12/device2020-07: 0 reports for this device; peer average 2.78/device2020-08: 0 reports for this device; peer average 1.9/device2020-09: 0 reports for this device; peer average 2.01/device2020-10: 0 reports for this device; peer average 2.32/device2020-11: 0 reports for this device; peer average 1.97/device2020-12: 0 reports for this device; peer average 1.94/device2021-01: 0 reports for this device; peer average 2.64/device2021-02: 0 reports for this device; peer average 2.25/device2021-03: 0 reports for this device; peer average 2.39/device2021-04: 0 reports for this device; peer average 2.35/device2021-05: 0 reports for this device; peer average 2.25/device2021-06: 0 reports for this device; peer average 2.32/device2021-07: 0 reports for this device; peer average 2.38/device2021-08: 0 reports for this device; peer average 2.45/device2021-09: 0 reports for this device; peer average 2.35/device2021-10: 0 reports for this device; peer average 2.85/device2021-11: 0 reports for this device; peer average 2.36/device2021-12: 0 reports for this device; peer average 3.62/device2022-01: 0 reports for this device; peer average 3.42/device2022-02: 0 reports for this device; peer average 2.83/device2022-03: 0 reports for this device; peer average 3.39/device2022-04: 0 reports for this device; peer average 3.11/device2022-05: 0 reports for this device; peer average 2.47/device2022-06: 0 reports for this device; peer average 2.58/device2022-07: 0 reports for this device; peer average 2.41/device2022-08: 0 reports for this device; peer average 2.61/device2022-09: 0 reports for this device; peer average 2.37/device2022-10: 0 reports for this device; peer average 2.45/device2022-11: 0 reports for this device; peer average 2.38/device2022-12: 0 reports for this device; peer average 2.59/device2023-01: 0 reports for this device; peer average 2.04/device2023-02: 0 reports for this device; peer average 2.27/device2023-03: 0 reports for this device; peer average 2.22/device2023-04: 0 reports for this device; peer average 2.56/device2023-05: 0 reports for this device; peer average 2.29/device2023-06: 0 reports for this device; peer average 2.39/device2023-07: 0 reports for this device; peer average 2.16/device2023-08: 0 reports for this device; peer average 1.92/device2023-09: 0 reports for this device; peer average 1.71/device2023-10: 0 reports for this device; peer average 1.75/device2023-11: 0 reports for this device; peer average 1.84/device2023-12: 0 reports for this device; peer average 1.52/device2024-01: 0 reports for this device; peer average 1.75/device2024-02: 0 reports for this device; peer average 2.03/device2024-03: 0 reports for this device; peer average 1.8/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1.75/device2024-06: 0 reports for this device; peer average 1.9/device2024-07: 0 reports for this device; peer average 1.69/device2024-08: 0 reports for this device; peer average 1.77/device2024-09: 0 reports for this device; peer average 1.79/device2024-10: 0 reports for this device; peer average 1.9/device2024-11: 0 reports for this device; peer average 1.73/device2024-12: 0 reports for this device; peer average 1.71/device2025-01: 0 reports for this device; peer average 1.77/device2025-02: 0 reports for this device; peer average 1.77/device2025-03: 0 reports for this device; peer average 2.05/device2025-04: 0 reports for this device; peer average 1.86/device2025-05: 0 reports for this device; peer average 1.94/device2025-06: 0 reports for this device; peer average 2.12/device2025-07: 0 reports for this device; peer average 1.89/device2025-08: 0 reports for this device; peer average 1.76/device2025-09: 0 reports for this device; peer average 1.54/device2025-10: 0 reports for this device; peer average 1.77/device2025-11: 0 reports for this device; peer average 1.78/device2025-12: 0 reports for this device; peer average 2.29/device2026-01: 0 reports for this device; peer average 2.02/device2026-02: 0 reports for this device; peer average 1.93/device2026-03: 0 reports for this device; peer average 1.88/device2026-04: 0 reports for this device; peer average 1.78/device2026-05: 0 reports for this device; peer average 1.86/device2026-06: 0 reports for this device; peer average 1.95/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
2019-0202.32
2019-0301.9
2019-0402.37
2019-0502.59
2019-0601.9
2019-0702.22
2019-0802.61
2019-0901.98
2019-1002.02
2019-1101.86
2019-1201.81
2020-0102.03
2020-0201.99
2020-0302.77
2020-0401.94
2020-0501.92
2020-0602.12
2020-0702.78
2020-0801.9
2020-0902.01
2020-1002.32
2020-1101.97
2020-1201.94
2021-0102.64
2021-0202.25
2021-0302.39
2021-0402.35
2021-0502.25
2021-0602.32
2021-0702.38
2021-0802.45
2021-0902.35
2021-1002.85
2021-1102.36
2021-1203.62
2022-0103.42
2022-0202.83
2022-0303.39
2022-0403.11
2022-0502.47
2022-0602.58
2022-0702.41
2022-0802.61
2022-0902.37
2022-1002.45
2022-1102.38
2022-1202.59
2023-0102.04
2023-0202.27
2023-0302.22
2023-0402.56
2023-0502.29
2023-0602.39
2023-0702.16
2023-0801.92
2023-0901.71
2023-1001.75
2023-1101.84
2023-1201.52
2024-0101.75
2024-0202.03
2024-0301.8
2024-0402
2024-0501.75
2024-0601.9
2024-0701.69
2024-0801.77
2024-0901.79
2024-1001.9
2024-1101.73
2024-1201.71
2025-0101.77
2025-0201.77
2025-0302.05
2025-0401.86
2025-0501.94
2025-0602.12
2025-0701.89
2025-0801.76
2025-0901.54
2025-1001.77
2025-1101.78
2025-1202.29
2026-0102.02
2026-0201.93
2026-0301.88
2026-0401.78
2026-0501.86
2026-0601.95
This device (reports/month)Average device in PHX, QHE (reports/device/month)

Regulatory clearances

  • K253992 SESE 2026-05-07 (k number procode)

Predicate lineage

K253992 — cites (transitively): K152754 (d1), K243643 (d1), K120121 (d2), K192778 (d2), K193373 (d2), K240591 (d2), K123954 (d3), K140749 (d3), K080642 (d3), K113069 (d3), K113121 (d3), K131353 (d3), K132239 (d3), K182878 (d3), K201393 (d3), K203447 (d3), K223316 (d3), K232595 (d3), K053569 (d4), K151459 (d4), K153452 (d4), K090127 (d4), K190562 (d4), K201023 (d4), K141635 (d4), K221404 (d4), K210390 (d4), K220523 (d4), K081127 (d5), K121771 (d5), K100886 (d5), K161668 (d5), K180159 (d5), K180906 (d5), K060515 (d5), K193105 (d5), K952830 (d5), K020541 (d5), K192994 (d5), K143258 (d5), K153436 (d5), K162496 (d5), K170851 (d5), K180556 (d5), K183239 (d5), K201755 (d5), K210583 (d5), K221059 (d5), K101433 (d6), K120370 (d6), K103111 (d6), K112316 (d6), K133614 (d6), K083894 (d6), K132897 (d6), K153217 (d6), K160025 (d6), K142112 (d6), K150135 (d6), K160924 (d6), K112802 (d6), K112906 (d6), K140942 (d6), K141972 (d6), K150105 (d6), K153075 (d6), K153310 (d6), K162422 (d6), K150847 (d6), K161366 (d6), K171067 (d6), K093513 (d6), K132640 (d6), K133256 (d6), K082310 (d6), K163230 (d6), K181079 (d6), K192132 (d6), K101310 (d6), K201193 (d6), K192198 (d6), K213389 (d6), P950002 (d7), P960025 (d7), K040166 (d7), K082500 (d7), K933785 (d7), K943462 (d7), K961685 (d7), K073202 (d7), K083626 (d7), K010170 (d7), K041906 (d7), K042842 (d7), K052792 (d7), K070369 (d7), K094035 (d7), K102487 (d7), K090705 (d7), K910500 (d7), K925242 (d7), K936159 (d7), K103662 (d7), K090353 (d7), K100175 (d7), K131467 (d7), K082698 (d7), K101302 (d7), K103169 (d7), K070095 (d7), K121741 (d7), K934695 (d7), K071416 (d7), K100043 (d7), K120368 (d7), K122037 (d7), K123045 (d7), K131669 (d7), K133650 (d7), K142450 (d7), K991460 (d7), P970015 (d7), K073144 (d7), K073440 (d7), K081614 (d7), K081917 (d7), K090064 (d7), K094025 (d7), K130573 (d7), K133216 (d7), K142161 (d7), K142404 (d7), K152704 (d7), K150788 (d7), K151310 (d7), K151322 (d7), K122870 (d7), K140319 (d7), K141665 (d7), K150481 (d7), K152304 (d7), K161230 (d7), K141740 (d7), K142117 (d7), K153008 (d7), K112986 (d7), K142488 (d7), K162351 (d7), K102026 (d7), K173260 (d7), K162719 (d7), K171046 (d7), K173606 (d7), K183083 (d7), K193636 (d7), K200879 (d7), K201267 (d7), K201605 (d7), K201646 (d7), K210191 (d7), K212411 (d7), K052261 (d8), K073291 (d8), P950019 (d8), K032396 (d8), K050327 (d8), K051588 (d8), K071535 (d8), K073102 (d8), K083762 (d8), K935484 (d8), K950827 (d8), K970501 (d8), K083026 (d8), K101229 (d8), K080822 (d8), K033926 (d8), K071795 (d8), K103731 (d8), P980048 (d8), K030327 (d8), K073285 (d8), K091813 (d8), K094042 (d8), K100214 (d8), K080528 (d8), K091956 (d8), K094050 (d8), K103117 (d8), K103223 (d8), K112780 (d8), K113378 (d8), K113756 (d8), K120068 (d8), K120316 (d8), K072791 (d8), K690353 (d8), K121760 (d8), K123027 (d8), K110632 (d8), K113348 (d8), K122967 (d8), K132601 (d8), K080699 (d8), K090816 (d8), K120918 (d8), K123231 (d8), K130820 (d8), K131082 (d8), K133455 (d8), K123059 (d8), K133585 (d8), K140423 (d8), K140833 (d8), K140417 (d8), K082309 (d8), K082712 (d8), K103297 (d8), K100945 (d8), K110843 (d8), K113138 (d8), K113561 (d8), K130699 (d8), K141405 (d8), K080281 (d8), K122989 (d8), K132700 (d8), K151472 (d8), K142264 (d8), K060506 (d8), K123486 (d8), K132624 (d8), K143393 (d8), K143616 (d8), K140257 (d8), K143226 (d8), K051023 (d8), K103374 (d8), K141896 (d8), K153419 (d8), K153782 (d8), K160051 (d8), K121211 (d8), K161379 (d8), K042992 (d8), K111863 (d8), K162715 (d8), K073109 (d8), K101301 (d8), K032064 (d8), K050058 (d8), K101363 (d8), K111675 (d8), K161081 (d8), K170569 (d8), K172926 (d8), K173722 (d8), K200885 (d8), K142559 (d8), K151128 (d8), K171689 (d8), K190959 (d8), K191581 (d8), K172888 (d8), K181644 (d8), K183447 (d8), K190655 (d8)

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

Manufacturer compliance record — Restor3d, Inc.

  • Warning Letter 2019-12-10 Conformis Inc.
  • VAI 2026-01-13 Conformis Inc. · 1 citations
  • VAI 2024-06-14 restor3d Inc. · 7 citations
  • VAI 2024-06-14 restor3d Inc. · 7 citations
  • VAI 2023-05-12 restor3d Inc. · 3 citations
  • VAI 2023-05-12 restor3d Inc. · 3 citations
  • NAI 2021-07-08 Conformis Inc. · 0 citations
  • OAI 2019-09-20 Conformis Inc. · 4 citations
  • VAI 2015-09-14 Conformis Inc. · 3 citations