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3D Printed Interbody Systems

Model WL4-264500 · Seaspine Orthopedics Corporation · DI 10889981306397

MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · Class II · 21 CFR 888.3080

PHM — Intervertebral Fusion Device With Bone Graft, Thoracic · Class II · 21 CFR 888.3080

UDILibrary device dossier · generated 2026-09-06 · 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.

257102019-01: 0 reports for this device; peer average 1.54/device2019-02: 0 reports for this device; peer average 1.22/device2019-03: 0 reports for this device; peer average 1.68/device2019-04: 0 reports for this device; peer average 1.46/device2019-05: 0 reports for this device; peer average 1.6/device2019-06: 0 reports for this device; peer average 1.57/device2019-07: 0 reports for this device; peer average 1.63/device2019-08: 0 reports for this device; peer average 1.36/device2019-09: 0 reports for this device; peer average 1.32/device2019-10: 0 reports for this device; peer average 1.83/device2019-11: 0 reports for this device; peer average 1.58/device2019-12: 0 reports for this device; peer average 1.34/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 1.74/device2020-03: 0 reports for this device; peer average 1.43/device2020-04: 0 reports for this device; peer average 1.43/device2020-05: 0 reports for this device; peer average 1.63/device2020-06: 0 reports for this device; peer average 1.82/device2020-07: 0 reports for this device; peer average 1.85/device2020-08: 0 reports for this device; peer average 1.64/device2020-09: 0 reports for this device; peer average 2.52/device2020-10: 0 reports for this device; peer average 2.03/device2020-11: 0 reports for this device; peer average 2.1/device2020-12: 0 reports for this device; peer average 1.76/device2021-01: 0 reports for this device; peer average 1.71/device2021-02: 0 reports for this device; peer average 1.74/device2021-03: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1.55/device2021-05: 0 reports for this device; peer average 1.6/device2021-06: 0 reports for this device; peer average 2.23/device2021-07: 0 reports for this device; peer average 1.73/device2021-08: 0 reports for this device; peer average 2.21/device2021-09: 0 reports for this device; peer average 1.73/device2021-10: 0 reports for this device; peer average 2.11/device2021-11: 0 reports for this device; peer average 1.85/device2021-12: 0 reports for this device; peer average 2.49/device2022-01: 0 reports for this device; peer average 3.1/device2022-02: 0 reports for this device; peer average 2.59/device2022-03: 0 reports for this device; peer average 1.76/device2022-04: 0 reports for this device; peer average 1.78/device2022-05: 0 reports for this device; peer average 2.13/device2022-06: 0 reports for this device; peer average 1.8/device2022-07: 0 reports for this device; peer average 2.25/device2022-08: 0 reports for this device; peer average 1.86/device2022-09: 0 reports for this device; peer average 1.79/device2022-10: 0 reports for this device; peer average 1.88/device2022-11: 0 reports for this device; peer average 1.94/device2022-12: 0 reports for this device; peer average 1.69/device2023-01: 0 reports for this device; peer average 2.39/device2023-02: 0 reports for this device; peer average 2.09/device2023-03: 0 reports for this device; peer average 1.72/device2023-04: 0 reports for this device; peer average 1.87/device2023-05: 0 reports for this device; peer average 2.04/device2023-06: 0 reports for this device; peer average 1.76/device2023-07: 0 reports for this device; peer average 2.04/device2023-08: 0 reports for this device; peer average 1.79/device2023-09: 0 reports for this device; peer average 1.97/device2023-10: 0 reports for this device; peer average 1.87/device2023-11: 0 reports for this device; peer average 9.8/device2023-12: 0 reports for this device; peer average 3.76/device2024-01: 0 reports for this device; peer average 1.95/device2024-02: 0 reports for this device; peer average 2.14/device2024-03: 0 reports for this device; peer average 1.9/device2024-04: 0 reports for this device; peer average 1.38/device2024-05: 0 reports for this device; peer average 1.81/device2024-06: 0 reports for this device; peer average 1.85/device2024-07: 0 reports for this device; peer average 1.94/device2024-08: 0 reports for this device; peer average 2.25/device2024-09: 0 reports for this device; peer average 1.91/device2024-10: 0 reports for this device; peer average 2.19/device2024-11: 0 reports for this device; peer average 1.73/device2024-12: 0 reports for this device; peer average 1.78/device2025-01: 0 reports for this device; peer average 1.85/device2025-02: 0 reports for this device; peer average 1.71/device2025-03: 0 reports for this device; peer average 1.69/device2025-04: 0 reports for this device; peer average 1.6/device2025-05: 0 reports for this device; peer average 1.66/device2025-06: 0 reports for this device; peer average 2.02/device2025-07: 0 reports for this device; peer average 1.81/device2025-08: 0 reports for this device; peer average 1.61/device2025-09: 0 reports for this device; peer average 1.66/device2025-10: 0 reports for this device; peer average 1.71/device2025-11: 0 reports for this device; peer average 2.03/device2025-12: 0 reports for this device; peer average 1.86/device2026-01: 0 reports for this device; peer average 1.89/device2026-02: 0 reports for this device; peer average 1.55/device2026-03: 0 reports for this device; peer average 2.75/device2026-04: 0 reports for this device; peer average 1.67/device2026-05: 0 reports for this device; peer average 1.58/device2026-06: 0 reports for this device; peer average 1.67/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.54
2019-0201.22
2019-0301.68
2019-0401.46
2019-0501.6
2019-0601.57
2019-0701.63
2019-0801.36
2019-0901.32
2019-1001.83
2019-1101.58
2019-1201.34
2020-0101.67
2020-0201.74
2020-0301.43
2020-0401.43
2020-0501.63
2020-0601.82
2020-0701.85
2020-0801.64
2020-0902.52
2020-1002.03
2020-1102.1
2020-1201.76
2021-0101.71
2021-0201.74
2021-0302
2021-0401.55
2021-0501.6
2021-0602.23
2021-0701.73
2021-0802.21
2021-0901.73
2021-1002.11
2021-1101.85
2021-1202.49
2022-0103.1
2022-0202.59
2022-0301.76
2022-0401.78
2022-0502.13
2022-0601.8
2022-0702.25
2022-0801.86
2022-0901.79
2022-1001.88
2022-1101.94
2022-1201.69
2023-0102.39
2023-0202.09
2023-0301.72
2023-0401.87
2023-0502.04
2023-0601.76
2023-0702.04
2023-0801.79
2023-0901.97
2023-1001.87
2023-1109.8
2023-1203.76
2024-0101.95
2024-0202.14
2024-0301.9
2024-0401.38
2024-0501.81
2024-0601.85
2024-0701.94
2024-0802.25
2024-0901.91
2024-1002.19
2024-1101.73
2024-1201.78
2025-0101.85
2025-0201.71
2025-0301.69
2025-0401.6
2025-0501.66
2025-0602.02
2025-0701.81
2025-0801.61
2025-0901.66
2025-1001.71
2025-1102.03
2025-1201.86
2026-0101.89
2026-0201.55
2026-0302.75
2026-0401.67
2026-0501.58
2026-0601.67
This device (reports/month)Average device in MAX, PHM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K213420 — cites (transitively): K082310 (d1), K172064 (d1), K201755 (d1), K111272 (d2), K121254 (d2), K133967 (d2), K134038 (d2), K163230 (d2), K181079 (d2), K192132 (d2), K071833 (d3), K092521 (d3), K093704 (d3), K113138 (d3), K130573 (d3), K140319 (d3), K141665 (d3), K150481 (d3), K152304 (d3), K161230 (d3), K112986 (d3), K142488 (d3), K162351 (d3), K102026 (d3), K173260 (d3), K080822 (d4), K082698 (d4), K072791 (d4), K081917 (d4), K071795 (d4), K110632 (d4), K113348 (d4), K122967 (d4), K132601 (d4), K080699 (d4), K090816 (d4), K120918 (d4), K123045 (d4), K123231 (d4), K130820 (d4), K131082 (d4), K133455 (d4), K082309 (d4), K082712 (d4), K103297 (d4), K100945 (d4), K110843 (d4), K112316 (d4), K113561 (d4), K130699 (d4), K133614 (d4), K141405 (d4), K060506 (d4), K123486 (d4), K132624 (d4), K143393 (d4), K143616 (d4), K141896 (d4), K153419 (d4), K153782 (d4), K160051 (d4), K121211 (d4), K161379 (d4), K162715 (d4), K080401 (d5), K071724 (d5), K073348 (d5), K051454 (d5), K063399 (d5), K080024 (d5), K083626 (d5), K083894 (d5), P960025 (d5), K031635 (d5), K080568 (d5), K101923 (d5), K073202 (d5), K101310 (d5), K080537 (d5), K072160 (d5), K031672 (d5), K103169 (d5), K023570 (d5), K062933 (d5), K073291 (d5), K091278 (d5), K092193 (d5), K100042 (d5), K130548 (d5), K031729 (d5), K040267 (d5), K042883 (d5), K042993 (d5), K051146 (d5), K051380 (d5), K051977 (d5), K053514 (d5), K061521 (d5), K072221 (d5), K072575 (d5), K123166 (d5), K043206 (d5), K133623 (d5), K101302 (d5), K081968 (d5), K100089 (d5), K131372 (d5), K123027 (d5), K140659 (d5), K053340 (d5), K100391 (d5), K150994 (d5), K151472 (d5), K100043 (d5), K131723 (d5), K140479 (d5), K143163 (d5), P950002 (d6), K043479 (d6), P950019 (d6), P970015 (d6), K042871 (d6), K052888 (d6), K082732 (d6), K050539 (d6), K063423 (d6), K974556 (d6), K092901 (d6), K090064 (d6), K103382 (d6), K083661 (d6), K093864 (d6), K100865 (d6), K101051 (d6), K120869 (d6), K133328 (d6), K141217 (d6), K082262 (d7), K090166 (d7), K073470 (d7), K080758 (d7), K082014 (d7), K093242 (d7), K082252 (d7) — cited as predicate by K222732, K240566, K240830, K241466

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

Manufacturer compliance record — Seaspine Orthopedics Corporation

  • Warning Letter 2026-02-24 IsoTis OrthoBiologics, Inc.
  • OAI 2025-10-17 IsoTis OrthoBiologics, Inc. · 3 citations
  • NAI 2022-04-22 SEASPINE ORTHOPEDICS CORPORATION · 0 citations
  • NAI 2022-04-22 SEASPINE ORTHOPEDICS CORPORATION · 0 citations
  • NAI 2018-08-14 SEASPINE ORTHOPEDICS CORPORATION · 0 citations
  • NAI 2018-08-14 SEASPINE ORTHOPEDICS CORPORATION · 0 citations
  • NAI 2015-09-25 IsoTis OrthoBiologics, Inc. · 0 citations
  • NAI 2012-04-27 IsoTis OrthoBiologics, Inc. · 0 citations