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

Calix Spinal Implant System

Model X034-0242PC-STR · Xtant Medical Holdings, Inc. · DI M697X0340242PCSTR1

MAX — Intervertebral Fusion Device With Bone Graft, Lumbar · 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 (1)

InitiatedRecall #ClassStatusReasonLink basis
2018-12-19Z-0790-2019Class IITerminatedThis recall has been initiated due to a change in packaging and sterilization method to address potential risks of compromised sterilization presented by the existing configuration.k number procode

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.

358102019-01: 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 1.69/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 1.65/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 1.36/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 1.73/device2020-03: 0 reports for this device; peer average 1.45/device2020-04: 0 reports for this device; peer average 1.43/device2020-05: 0 reports for this device; peer average 1.64/device2020-06: 0 reports for this device; peer average 1.84/device2020-07: 0 reports for this device; peer average 1.85/device2020-08: 0 reports for this device; peer average 1.63/device2020-09: 0 reports for this device; peer average 2.52/device2020-10: 0 reports for this device; peer average 2.05/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 1.7/device2021-02: 0 reports for this device; peer average 1.72/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 1.72/device2021-10: 0 reports for this device; peer average 2.11/device2021-11: 0 reports for this device; peer average 1.84/device2021-12: 0 reports for this device; peer average 2.54/device2022-01: 0 reports for this device; peer average 3.14/device2022-02: 0 reports for this device; peer average 2.62/device2022-03: 0 reports for this device; peer average 1.78/device2022-04: 0 reports for this device; peer average 1.76/device2022-05: 0 reports for this device; peer average 2.13/device2022-06: 0 reports for this device; peer average 1.79/device2022-07: 0 reports for this device; peer average 2.21/device2022-08: 0 reports for this device; peer average 1.86/device2022-09: 0 reports for this device; peer average 1.78/device2022-10: 0 reports for this device; peer average 1.87/device2022-11: 0 reports for this device; peer average 1.93/device2022-12: 0 reports for this device; peer average 1.7/device2023-01: 0 reports for this device; peer average 2.44/device2023-02: 0 reports for this device; peer average 2.05/device2023-03: 0 reports for this device; peer average 1.71/device2023-04: 0 reports for this device; peer average 1.81/device2023-05: 0 reports for this device; peer average 2.04/device2023-06: 0 reports for this device; peer average 1.75/device2023-07: 0 reports for this device; peer average 2.04/device2023-08: 0 reports for this device; peer average 1.73/device2023-09: 0 reports for this device; peer average 1.97/device2023-10: 0 reports for this device; peer average 1.85/device2023-11: 0 reports for this device; peer average 10.03/device2023-12: 0 reports for this device; peer average 3.95/device2024-01: 0 reports for this device; peer average 1.86/device2024-02: 0 reports for this device; peer average 2.13/device2024-03: 0 reports for this device; peer average 1.9/device2024-04: 0 reports for this device; peer average 1.36/device2024-05: 0 reports for this device; peer average 1.58/device2024-06: 0 reports for this device; peer average 1.79/device2024-07: 0 reports for this device; peer average 1.93/device2024-08: 0 reports for this device; peer average 2.27/device2024-09: 0 reports for this device; peer average 1.9/device2024-10: 0 reports for this device; peer average 2.13/device2024-11: 0 reports for this device; peer average 1.74/device2024-12: 0 reports for this device; peer average 1.69/device2025-01: 0 reports for this device; peer average 1.85/device2025-02: 0 reports for this device; peer average 1.66/device2025-03: 0 reports for this device; peer average 1.66/device2025-04: 0 reports for this device; peer average 1.6/device2025-05: 0 reports for this device; peer average 1.65/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 1.59/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 1.85/device2026-01: 0 reports for this device; peer average 1.94/device2026-02: 0 reports for this device; peer average 1.53/device2026-03: 0 reports for this device; peer average 2.76/device2026-04: 0 reports for this device; peer average 1.57/device2026-05: 0 reports for this device; peer average 1.58/device2026-06: 0 reports for this device; peer average 1.6/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
2019-0301.69
2019-0401.46
2019-0501.6
2019-0601.57
2019-0701.65
2019-0801.36
2019-0901.32
2019-1001.83
2019-1101.58
2019-1201.36
2020-0101.67
2020-0201.73
2020-0301.45
2020-0401.43
2020-0501.64
2020-0601.84
2020-0701.85
2020-0801.63
2020-0902.52
2020-1002.05
2020-1102.1
2020-1201.76
2021-0101.7
2021-0201.72
2021-0302
2021-0401.55
2021-0501.6
2021-0602.23
2021-0701.73
2021-0802.21
2021-0901.72
2021-1002.11
2021-1101.84
2021-1202.54
2022-0103.14
2022-0202.62
2022-0301.78
2022-0401.76
2022-0502.13
2022-0601.79
2022-0702.21
2022-0801.86
2022-0901.78
2022-1001.87
2022-1101.93
2022-1201.7
2023-0102.44
2023-0202.05
2023-0301.71
2023-0401.81
2023-0502.04
2023-0601.75
2023-0702.04
2023-0801.73
2023-0901.97
2023-1001.85
2023-11010.03
2023-1203.95
2024-0101.86
2024-0202.13
2024-0301.9
2024-0401.36
2024-0501.58
2024-0601.79
2024-0701.93
2024-0802.27
2024-0901.9
2024-1002.13
2024-1101.74
2024-1201.69
2025-0101.85
2025-0201.66
2025-0301.66
2025-0401.6
2025-0501.65
2025-0602.02
2025-0701.81
2025-0801.61
2025-0901.59
2025-1001.71
2025-1102.03
2025-1201.85
2026-0101.94
2026-0201.53
2026-0302.76
2026-0401.57
2026-0501.58
2026-0601.6
This device (reports/month)Average device in MAX (reports/device/month)

Regulatory clearances

  • K170119 SESE 2017-09-29 (k number procode)

Predicate lineage

K170119 — cites (transitively): K112014 (d1), K112036 (d1), K131350 (d1), K153782 (d1), K160597 (d1), K160916 (d1), K160958 (d1), K161230 (d1), K040482 (d2), K040928 (d2), K050624 (d2), K050861 (d2), K073470 (d2), K080699 (d2), K082406 (d2), K091381 (d2), K092574 (d2), K072970 (d2), K073291 (d2), K081917 (d2), K082698 (d2), K100043 (d2), K123045 (d2), K131723 (d2), K140319 (d2), K140479 (d2), K141665 (d2), K143163 (d2), K082252 (d2), K110327 (d2), K120101 (d2), K150643 (d2), K071795 (d2), K143740 (d2), K150994 (d2), K141896 (d2), K153419 (d2), K160051 (d2), K061016 (d3), K082262 (d3), K090507 (d3), K110632 (d3), K113348 (d3), K122967 (d3), K132601 (d3), K103382 (d3), K090816 (d3), K120918 (d3), K123231 (d3), K130820 (d3), K131082 (d3), K133455 (d3), K123027 (d3), K140659 (d3), K083661 (d3), K093704 (d3), K093864 (d3), K100865 (d3), K101051 (d3), K120869 (d3), K133328 (d3), K141217 (d3), K073109 (d3), K101301 (d3), K141942 (d3), K151472 (d3), K090166 (d4), P960025 (d4), K080758 (d4), K082014 (d4), K093242 (d4), K071724 (d4), K073348 (d4), K031635 (d4), K080568 (d4), K101923 (d4), K082732 (d4), K080537 (d4), K023570 (d4), K062933 (d4), K072791 (d4), K082310 (d4), K091278 (d4), K092193 (d4), K100042 (d4), K130548 (d4), K043206 (d4), K133623 (d4), K101310 (d4), K102090 (d4), K111122 (d4), K133200 (d4), K133286 (d4), K043479 (d5), P950002 (d5), P950019 (d5), P970015 (d5), K083186 (d5), K092901 (d5), K072415 (d5), K003836 (d6), K010930 (d6) — cited as predicate by K203520

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

Manufacturer compliance record — Xtant Medical Holdings, Inc.

  • Warning Letter 2013-01-28 XTANT Medical Holdings, Inc
  • Warning Letter 2013-01-28 XTANT Medical Holdings, Inc
  • Warning Letter 2013-01-28 XTANT Medical Holdings, Inc
  • Warning Letter 2013-01-28 XTANT Medical Holdings, Inc
  • NAI 2017-08-25 XTANT Medical Holdings, Inc · 0 citations
  • NAI 2017-08-25 XTANT Medical Holdings, Inc · 0 citations
  • VAI 2013-07-12 XTANT Medical Holdings, Inc · 1 citations
  • VAI 2013-07-12 XTANT Medical Holdings, Inc · 1 citations
  • NAI 2013-07-11 XTANT Medical Holdings, Inc · 0 citations
  • NAI 2013-07-11 XTANT Medical Holdings, Inc · 0 citations
  • OAI 2012-07-27 XTANT Medical Holdings, Inc · 6 citations
  • OAI 2012-07-27 XTANT Medical Holdings, Inc · 6 citations
  • OAI 2012-07-26 XTANT Medical Holdings, Inc · 12 citations
  • OAI 2012-07-26 XTANT Medical Holdings, Inc · 12 citations