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

CORNERSTONE® PSR Cervical Fusion System

Model 6273144 · MEDTRONIC SOFAMOR DANEK, INC. · DI 00613994157942

MQP — Spinal Vertebral Body Replacement Device · Class II · 21 CFR 888.3060

ODP — Intervertebral Fusion Device With Bone Graft, Cervical · Class II · 21 CFR 888.3080

UDILibrary device dossier · generated 2026-09-11 · 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.

13462019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 1.23/device2019-03: 0 reports for this device; peer average 1.8/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1.56/device2019-06: 0 reports for this device; peer average 1.69/device2019-07: 0 reports for this device; peer average 1.56/device2019-08: 0 reports for this device; peer average 5.5/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 2.79/device2019-11: 0 reports for this device; peer average 1.17/device2019-12: 0 reports for this device; peer average 1.58/device2020-01: 0 reports for this device; peer average 1.5/device2020-02: 0 reports for this device; peer average 1.33/device2020-03: 0 reports for this device; peer average 1.47/device2020-04: 0 reports for this device; peer average 1.4/device2020-05: 0 reports for this device; peer average 1.35/device2020-06: 0 reports for this device; peer average 1.21/device2020-07: 0 reports for this device; peer average 2.06/device2020-08: 0 reports for this device; peer average 1.43/device2020-09: 0 reports for this device; peer average 1.57/device2020-10: 0 reports for this device; peer average 1.64/device2020-11: 0 reports for this device; peer average 1.11/device2020-12: 0 reports for this device; peer average 1.6/device2021-01: 0 reports for this device; peer average 1.29/device2021-02: 0 reports for this device; peer average 1.37/device2021-03: 0 reports for this device; peer average 1.77/device2021-04: 0 reports for this device; peer average 1.33/device2021-05: 0 reports for this device; peer average 1.25/device2021-06: 0 reports for this device; peer average 3.46/device2021-07: 0 reports for this device; peer average 1.5/device2021-08: 0 reports for this device; peer average 1.56/device2021-09: 0 reports for this device; peer average 1.6/device2021-10: 0 reports for this device; peer average 1.57/device2021-11: 0 reports for this device; peer average 1.31/device2021-12: 0 reports for this device; peer average 1.42/device2022-01: 0 reports for this device; peer average 1.33/device2022-02: 0 reports for this device; peer average 1.56/device2022-03: 0 reports for this device; peer average 1.66/device2022-04: 0 reports for this device; peer average 1.5/device2022-05: 0 reports for this device; peer average 1.81/device2022-06: 0 reports for this device; peer average 1.56/device2022-07: 0 reports for this device; peer average 1.39/device2022-08: 0 reports for this device; peer average 1.41/device2022-09: 0 reports for this device; peer average 2.19/device2022-10: 0 reports for this device; peer average 1.45/device2022-11: 0 reports for this device; peer average 1.88/device2022-12: 0 reports for this device; peer average 1.25/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 1.36/device2023-03: 0 reports for this device; peer average 2.33/device2023-04: 0 reports for this device; peer average 1.09/device2023-05: 0 reports for this device; peer average 1.37/device2023-06: 0 reports for this device; peer average 1.13/device2023-07: 0 reports for this device; peer average 1.71/device2023-08: 0 reports for this device; peer average 3.82/device2023-09: 0 reports for this device; peer average 1.38/device2023-10: 0 reports for this device; peer average 1.64/device2023-11: 0 reports for this device; peer average 1.17/device2023-12: 0 reports for this device; peer average 1.35/device2024-01: 0 reports for this device; peer average 2.17/device2024-02: 0 reports for this device; peer average 1.7/device2024-03: 0 reports for this device; peer average 1.88/device2024-04: 0 reports for this device; peer average 1.54/device2024-05: 0 reports for this device; peer average 1.86/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 1.63/device2024-08: 0 reports for this device; peer average 1.33/device2024-09: 0 reports for this device; peer average 1.57/device2024-10: 0 reports for this device; peer average 1.26/device2024-11: 0 reports for this device; peer average 1.46/device2024-12: 0 reports for this device; peer average 1.54/device2025-01: 0 reports for this device; peer average 1.39/device2025-02: 0 reports for this device; peer average 1.76/device2025-03: 0 reports for this device; peer average 2.77/device2025-04: 0 reports for this device; peer average 1.76/device2025-05: 0 reports for this device; peer average 1.97/device2025-06: 0 reports for this device; peer average 1.56/device2025-07: 0 reports for this device; peer average 1.75/device2025-08: 0 reports for this device; peer average 1.69/device2025-09: 0 reports for this device; peer average 1.53/device2025-10: 0 reports for this device; peer average 1.53/device2025-11: 0 reports for this device; peer average 1.62/device2025-12: 0 reports for this device; peer average 1.6/device2026-01: 0 reports for this device; peer average 1.39/device2026-02: 0 reports for this device; peer average 1.26/device2026-03: 0 reports for this device; peer average 1.84/device2026-04: 0 reports for this device; peer average 1.68/device2026-05: 0 reports for this device; peer average 1.68/device2026-06: 0 reports for this device; peer average 1.81/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0201.23
2019-0301.8
2019-0401
2019-0501.56
2019-0601.69
2019-0701.56
2019-0805.5
2019-0901
2019-1002.79
2019-1101.17
2019-1201.58
2020-0101.5
2020-0201.33
2020-0301.47
2020-0401.4
2020-0501.35
2020-0601.21
2020-0702.06
2020-0801.43
2020-0901.57
2020-1001.64
2020-1101.11
2020-1201.6
2021-0101.29
2021-0201.37
2021-0301.77
2021-0401.33
2021-0501.25
2021-0603.46
2021-0701.5
2021-0801.56
2021-0901.6
2021-1001.57
2021-1101.31
2021-1201.42
2022-0101.33
2022-0201.56
2022-0301.66
2022-0401.5
2022-0501.81
2022-0601.56
2022-0701.39
2022-0801.41
2022-0902.19
2022-1001.45
2022-1101.88
2022-1201.25
2023-0102
2023-0201.36
2023-0302.33
2023-0401.09
2023-0501.37
2023-0601.13
2023-0701.71
2023-0803.82
2023-0901.38
2023-1001.64
2023-1101.17
2023-1201.35
2024-0102.17
2024-0201.7
2024-0301.88
2024-0401.54
2024-0501.86
2024-0601.5
2024-0701.63
2024-0801.33
2024-0901.57
2024-1001.26
2024-1101.46
2024-1201.54
2025-0101.39
2025-0201.76
2025-0302.77
2025-0401.76
2025-0501.97
2025-0601.56
2025-0701.75
2025-0801.69
2025-0901.53
2025-1001.53
2025-1101.62
2025-1201.6
2026-0101.39
2026-0201.26
2026-0301.84
2026-0401.68
2026-0501.68
2026-0601.81
This device (reports/month)Average device in MQP, ODP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K111264 — cites (transitively): K081917 (d1), K093093 (d1) — cited as predicate by K141599, K153373, K192502, K242303

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

Manufacturer compliance record — MEDTRONIC SOFAMOR DANEK, INC.

  • NAI 2026-02-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2017-10-26 Medtronic Sofamor Danek USA, Inc · 0 citations
  • VAI 2015-11-03 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2015-10-23 Medtronic Sofamor Danek USA Inc · 1 citations
  • VAI 2014-03-11 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2013-07-15 Medtronic Sofamor Danek USA, Inc · 0 citations
  • NAI 2013-07-15 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2012-06-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2011-02-23 Medtronic Sofamor Danek Usa Inc · 0 citations
  • VAI 2010-08-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2010-03-04 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2010-02-25 Medtronic Sofamor Danek USA Inc · 0 citations