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R1 Reverse Shoulder System

Model 1230-5213 · CATALYST ORTHOSCIENCE INC. · DI 00811596031350

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

UDILibrary device dossier · generated 2026-09-07 · 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 3.44/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 1.74/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 1.74/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 1.99/device2024-05: 0 reports for this device; peer average 1.73/device2024-06: 0 reports for this device; peer average 1.88/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 1.77/device2024-10: 0 reports for this device; peer average 1.9/device2024-11: 0 reports for this device; peer average 1.72/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 2.04/device2025-04: 0 reports for this device; peer average 1.87/device2025-05: 0 reports for this device; peer average 1.94/device2025-06: 0 reports for this device; peer average 2.13/device2025-07: 0 reports for this device; peer average 1.89/device2025-08: 0 reports for this device; peer average 1.73/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
2022-0303.44
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
2023-1001.74
2023-1101.84
2023-1201.52
2024-0101.74
2024-0202.03
2024-0301.8
2024-0401.99
2024-0501.73
2024-0601.88
2024-0701.69
2024-0801.77
2024-0901.77
2024-1001.9
2024-1101.72
2024-1201.71
2025-0101.77
2025-0201.77
2025-0302.04
2025-0401.87
2025-0501.94
2025-0602.13
2025-0701.89
2025-0801.73
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 (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K202611 — cites (transitively): K141990 (d1), K162455 (d1), K172351 (d1), K173900 (d1), K190290 (d1), K193372 (d1), K080402 (d2), K082120 (d2), K100741 (d2), K103208 (d2), K111735 (d2), K122698 (d2), K130048 (d2), K140904 (d2), K950594 (d2), K950651 (d2), K030941 (d2), K100142 (d2), K150488 (d2), K052906 (d2), K111061 (d2), K141006 (d2), K133349 (d2), K142863 (d2), K113413 (d2), K162024 (d2), K071147 (d3), K053274 (d3), K130129 (d3), K123814 (d3), K130759 (d3), K132285 (d3), K140071 (d3), K123982 (d3), K060874 (d4), K111097 (d4), K992525 (d4), K994392 (d4) — cited as predicate by K211991, K213349, K221467, K222317, K223655, K232583, K234105, K243509

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

Manufacturer compliance record — CATALYST ORTHOSCIENCE INC.

  • NAI 2024-07-10 Catalyst Orthoscience, Inc. · 0 citations
  • NAI 2024-07-10 Catalyst Orthoscience, Inc. · 0 citations