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37mm W X 28mm D X 18mm H, 20°, PILLAR SA Ti, STERILE

Model 82-3713SP · Orthofix US LLC · DI 18257200161010

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

OVD — Intervertebral Fusion Device With Integrated Fixation, Lumbar · Class II · 21 CFR 888.3080

UDILibrary device dossier · generated 2026-09-16 · 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
2025-06-24Z-2555-2025Class IIOpen, ClassifiedA 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.code info di

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.

24682019-01: 0 reports for this device; peer average 1.52/device2019-02: 0 reports for this device; peer average 1.3/device2019-03: 0 reports for this device; peer average 1.72/device2019-04: 0 reports for this device; peer average 1.4/device2019-05: 0 reports for this device; peer average 1.56/device2019-06: 0 reports for this device; peer average 1.62/device2019-07: 0 reports for this device; peer average 1.61/device2019-08: 0 reports for this device; peer average 1.35/device2019-09: 0 reports for this device; peer average 1.66/device2019-10: 0 reports for this device; peer average 1.97/device2019-11: 0 reports for this device; peer average 1.55/device2019-12: 0 reports for this device; peer average 1.44/device2020-01: 0 reports for this device; peer average 1.69/device2020-02: 0 reports for this device; peer average 1.85/device2020-03: 0 reports for this device; peer average 1.52/device2020-04: 0 reports for this device; peer average 1.4/device2020-05: 0 reports for this device; peer average 1.59/device2020-06: 0 reports for this device; peer average 2.1/device2020-07: 0 reports for this device; peer average 2.24/device2020-08: 0 reports for this device; peer average 1.58/device2020-09: 0 reports for this device; peer average 2.78/device2020-10: 0 reports for this device; peer average 2.16/device2020-11: 0 reports for this device; peer average 2.38/device2020-12: 0 reports for this device; peer average 1.64/device2021-01: 0 reports for this device; peer average 1.81/device2021-02: 0 reports for this device; peer average 1.76/device2021-03: 0 reports for this device; peer average 1.94/device2021-04: 0 reports for this device; peer average 1.63/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 2.36/device2021-07: 0 reports for this device; peer average 1.83/device2021-08: 0 reports for this device; peer average 2.35/device2021-09: 0 reports for this device; peer average 1.72/device2021-10: 0 reports for this device; peer average 2.27/device2021-11: 0 reports for this device; peer average 1.91/device2021-12: 0 reports for this device; peer average 2.72/device2022-01: 0 reports for this device; peer average 3.24/device2022-02: 0 reports for this device; peer average 2.85/device2022-03: 0 reports for this device; peer average 1.82/device2022-04: 0 reports for this device; peer average 1.76/device2022-05: 0 reports for this device; peer average 2.28/device2022-06: 0 reports for this device; peer average 1.74/device2022-07: 0 reports for this device; peer average 2.14/device2022-08: 0 reports for this device; peer average 2.07/device2022-09: 0 reports for this device; peer average 1.88/device2022-10: 0 reports for this device; peer average 1.84/device2022-11: 0 reports for this device; peer average 1.86/device2022-12: 0 reports for this device; peer average 1.67/device2023-01: 0 reports for this device; peer average 2.27/device2023-02: 0 reports for this device; peer average 1.96/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 1.91/device2023-06: 0 reports for this device; peer average 1.64/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.7/device2023-09: 0 reports for this device; peer average 1.9/device2023-10: 0 reports for this device; peer average 1.73/device2023-11: 0 reports for this device; peer average 8.42/device2023-12: 0 reports for this device; peer average 3.45/device2024-01: 0 reports for this device; peer average 1.87/device2024-02: 0 reports for this device; peer average 2.08/device2024-03: 0 reports for this device; peer average 1.84/device2024-04: 0 reports for this device; peer average 1.46/device2024-05: 0 reports for this device; peer average 1.76/device2024-06: 0 reports for this device; peer average 1.81/device2024-07: 0 reports for this device; peer average 1.97/device2024-08: 0 reports for this device; peer average 2.19/device2024-09: 0 reports for this device; peer average 1.87/device2024-10: 0 reports for this device; peer average 2.1/device2024-11: 0 reports for this device; peer average 1.76/device2024-12: 0 reports for this device; peer average 1.82/device2025-01: 0 reports for this device; peer average 1.82/device2025-02: 0 reports for this device; peer average 1.63/device2025-03: 0 reports for this device; peer average 1.64/device2025-04: 0 reports for this device; peer average 1.59/device2025-05: 0 reports for this device; peer average 1.64/device2025-06: 0 reports for this device; peer average 1.96/device2025-07: 0 reports for this device; peer average 1.95/device2025-08: 0 reports for this device; peer average 1.61/device2025-09: 0 reports for this device; peer average 1.68/device2025-10: 0 reports for this device; peer average 1.72/device2025-11: 0 reports for this device; peer average 1.91/device2025-12: 0 reports for this device; peer average 1.83/device2026-01: 0 reports for this device; peer average 1.83/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 2.67/device2026-04: 0 reports for this device; peer average 1.6/device2026-05: 0 reports for this device; peer average 1.57/device2026-06: 0 reports for this device; peer average 1.62/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.52
2019-0201.3
2019-0301.72
2019-0401.4
2019-0501.56
2019-0601.62
2019-0701.61
2019-0801.35
2019-0901.66
2019-1001.97
2019-1101.55
2019-1201.44
2020-0101.69
2020-0201.85
2020-0301.52
2020-0401.4
2020-0501.59
2020-0602.1
2020-0702.24
2020-0801.58
2020-0902.78
2020-1002.16
2020-1102.38
2020-1201.64
2021-0101.81
2021-0201.76
2021-0301.94
2021-0401.63
2021-0502
2021-0602.36
2021-0701.83
2021-0802.35
2021-0901.72
2021-1002.27
2021-1101.91
2021-1202.72
2022-0103.24
2022-0202.85
2022-0301.82
2022-0401.76
2022-0502.28
2022-0601.74
2022-0702.14
2022-0802.07
2022-0901.88
2022-1001.84
2022-1101.86
2022-1201.67
2023-0102.27
2023-0201.96
2023-0301.72
2023-0401.87
2023-0501.91
2023-0601.64
2023-0702
2023-0801.7
2023-0901.9
2023-1001.73
2023-1108.42
2023-1203.45
2024-0101.87
2024-0202.08
2024-0301.84
2024-0401.46
2024-0501.76
2024-0601.81
2024-0701.97
2024-0802.19
2024-0901.87
2024-1002.1
2024-1101.76
2024-1201.82
2025-0101.82
2025-0201.63
2025-0301.64
2025-0401.59
2025-0501.64
2025-0601.96
2025-0701.95
2025-0801.61
2025-0901.68
2025-1001.72
2025-1101.91
2025-1201.83
2026-0101.83
2026-0201.5
2026-0302.67
2026-0401.6
2026-0501.57
2026-0601.62
This device (reports/month)Average device in MAX, OVD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K240749 — cites (transitively): K200052 (d1), K233694 (d1), K172437 (d2), K121211 (d2), K201671 (d2), K220711 (d2), K222732 (d2), K101310 (d3), K083475 (d3), K133827 (d3), K162212 (d3), K172816 (d3), K191391 (d3), K072407 (d3), K200885 (d3), K201193 (d3), K210583 (d3), K213420 (d3), K071922 (d4), K073109 (d4), K080314 (d4), K091301 (d4), K102090 (d4), K110327 (d4), K111626 (d4), K120345 (d4), K123767 (d4), K133577 (d4), K150135 (d4), K151128 (d4), K120991 (d4), K142277 (d4), K162103 (d4), K102293 (d4), K160597 (d4), K163361 (d4), K170157 (d4), K170318 (d4), K181357 (d4), K171538 (d4), K142488 (d4), K171046 (d4), K173260 (d4), K173606 (d4), K183083 (d4), K192132 (d4), K193636 (d4), K200879 (d4), K201267 (d4), K201605 (d4), K201646 (d4), K201755 (d4), K082310 (d4), K172064 (d4), K072970 (d5), K093242 (d5), K082262 (d5), K090507 (d5), K080615 (d5), K042571 (d5), K050624 (d5), K061836 (d5), K062132 (d5), K082014 (d5), P960025 (d5), K083026 (d5), K100175 (d5), K112405 (d5), K113528 (d5), K122591 (d5), K123027 (d5), K132897 (d5), K071724 (d5), K081888 (d5), K120368 (d5), K140474 (d5), K082309 (d5), K082712 (d5), K102026 (d5), K103297 (d5), K112986 (d5), K071416 (d5), K100043 (d5), K122037 (d5), K123045 (d5), K131669 (d5), K133650 (d5), K142450 (d5), K991460 (d5), P970015 (d5), K130177 (d5), K082252 (d5), K120101 (d5), K150643 (d5), K073669 (d5), K120570 (d5), K140142 (d5), K153107 (d5), K153495 (d5), K000682 (d5), K000684 (d5), K011815 (d5), K040112 (d5), K041860 (d5), K041965 (d5), K060290 (d5), K060514 (d5), K063049 (d5), K070946 (d5), K073460 (d5), K082625 (d5), K083032 (d5), K083286 (d5), K092556 (d5), K102694 (d5), K111620 (d5), K112437 (d5), K133668 (d5), K133974 (d5), K140814 (d5), K142906 (d5), K143697 (d5), K153716 (d5), K951303 (d5), K982732 (d5), K142218 (d5), K142397 (d5), K142498 (d5), K143578 (d5), P950002 (d5), K120275 (d5), K153615 (d5), K160125 (d5), K151322 (d5), K162715 (d5), K022791 (d5), K111272 (d5), K121254 (d5), K133967 (d5), K134038 (d5), K162351 (d5), K080822 (d5), K101301 (d5), K100865 (d5), K102313 (d5), K122097 (d5), K123231 (d5), K130478 (d5), K131276 (d5), K151665 (d5), K152022 (d5), K161223 (d5), K170962 (d5), K171031 (d5), K032064 (d5), K050058 (d5), K101363 (d5), K111675 (d5), K161081 (d5), K170569 (d5), K172926 (d5), K173722 (d5), K181079 (d5), K073291 (d5), K094025 (d5), K142559 (d5), K171689 (d5), K190959 (d5), K191581 (d5), K172888 (d5), K181644 (d5), K183447 (d5), K190655 (d5), K163230 (d5), K052261 (d6), P950019 (d6), K073470 (d6), K080758 (d6), K083661 (d6), K093704 (d6), K080588 (d6), K081614 (d6), K012694 (d6), K083694 (d6), K071833 (d6), K092521 (d6), K963798 (d6), K043248 (d6), K052776 (d6), K090353 (d6), K073285 (d6), K100214 (d6), P980048 (d6), K033926 (d6), K071795 (d6), K103731 (d6), K050553 (d6), K072465 (d6), K091426 (d6), K113138 (d6), K030327 (d6), K091813 (d6), K094042 (d6), K113447 (d6), K082732 (d6), K080537 (d6), K031302 (d6), K040284 (d6), K072991 (d6), K083389 (d6), K072253 (d6), K103382 (d6), K690353 (d6), K121760 (d6), K052483 (d6), K121672 (d6), K963172 (d6), K130573 (d6), K040022 (d6), K080667 (d6), K132502 (d6), K062151 (d6), K130699 (d6), K101720 (d6), K090675 (d6), K132886 (d6), K011084 (d6), K140482 (d6), K140417 (d6), K083626 (d6), K121333 (d6), K051567 (d6), K103332 (d6), K060665 (d6), K112756 (d6), K121107 (d6), K131449 (d6), K101421 (d6), K955472 (d6), K141942 (d6), K141665 (d6), K142264 (d6), K143163 (d6), K100210 (d6), K123997 (d6), K143740 (d6), K113285 (d6), K142645 (d6), K152475 (d6), K142026 (d6), K142345 (d6), K150321 (d6), K001945 (d6), K011978 (d6), K012114 (d6), K021932 (d6), K023802 (d6), K030597 (d6), K030858 (d6), K033975 (d6), K033995 (d6), K040777 (d6), K051986 (d6), K061753 (d6), K062494 (d6), K062564 (d6), K082807 (d6), K092493 (d6), K092812 (d6), K983787 (d6), K082698 (d6), K103169 (d6), K133494 (d6), K133614 (d6), K150362 (d6), K150481 (d6), K152304 (d6), K150053 (d6), K151939 (d6), K140479 (d6), K161379 (d6), K140319 (d6), K161230 (d6), K120918 (d6), K153419 (d6), K110543 (d6), K132053 (d6), K121332 (d6), K133205 (d6), K160547 (d6), K162358 (d6), K163491 (d6), K170503 (d6), K102323 (d6), K121049 (d6), K150619 (d6), K153373 (d6), K161442 (d6), K161888 (d6), K181014 (d6), K140055 (d6), K142589 (d6), K163269 (d6), K170399 (d6), K173535 (d6), K183557 (d6), K192018 (d6), K013248 (d7), K020602 (d7), K072832 (d7), K080522 (d7), K073177 (d7), K090425 (d7), K091088 (d7), K092336 (d7), P000028 (d7), K072083 (d7), K082300 (d7), K081917 (d7), K101302 (d7), K033805 (d7), K092038 (d7), K003275 (d7), K041389 (d7), K050850 (d7), K060506 (d7), K040721 (d7), K051665 (d7), K070775 (d7), K092146 (d7), K090841 (d7), K042695 (d7), K072791 (d7), K031672 (d7), K110843 (d7), K000636 (d7), K063875 (d7), K073527 (d7), K100271 (d7), K101056 (d7), K113760 (d7), K060736 (d7), K061748 (d7), K062216 (d7), K101240 (d7), K993106 (d7), K092211 (d7), K120031 (d7), K122630 (d7), K102067 (d7), K110632 (d7), K113348 (d7), K122967 (d7), K132601 (d7), K100967 (d7), K132584 (d7), K080508 (d7), K080699 (d7), K090816 (d7), K130820 (d7), K131082 (d7), K133455 (d7), K111122 (d7), K133200 (d7), K133286 (d7), K090064 (d7), K110733 (d7), K113518 (d7), K032812 (d7), K083714 (d7), K100889 (d7), K093864 (d7), K101051 (d7), K120869 (d7), K133328 (d7), K141217 (d7), K102957 (d7), K081611 (d7), K140003 (d7), K140921 (d7), K142050 (d7), K100945 (d7), K112316 (d7), K113561 (d7), K141405 (d7), K142152 (d7), K113559 (d7), K123486 (d7), K132624 (d7), K143393 (d7), K143616 (d7), K103111 (d7), K121649 (d7), K141953 (d7), K111264 (d7), K150994 (d7), K151472 (d7), K141896 (d7), K153782 (d7), K160051 (d7), K102547 (d7), K131025 (d7), K142299 (d7), K141135 (d7), K100089 (d7), K150673 (d7), K151276 (d7), K151773 (d7), K092193 (d7), K093669 (d7), K112095 (d7), K122588 (d7), K143258 (d7), K148529 (d7), K151596 (d7), K153122 (d7), K160955 (d7), K170676 (d7), K171686 (d7), K172676 (d7), K180364 (d7), K090166 (d8), K040593 (d8), K082801 (d8), K080401 (d8), K102257 (d8), K073202 (d8), K073348 (d8), K073351 (d8), K082260 (d8), K051454 (d8), K063399 (d8), K080024 (d8), K083186 (d8), K093093 (d8), K083894 (d8), K031635 (d8), K080568 (d8), K101923 (d8), K062083 (d8), K101812 (d8), K080971 (d8), K092070 (d8), K072160 (d8), K000536 (d8), K053581 (d8), K023570 (d8), K062933 (d8), K091278 (d8), K100042 (d8), K132594 (d8), K130548 (d8), K031729 (d8), K040267 (d8), K042883 (d8), K042993 (d8), K051146 (d8), K051380 (d8), K051977 (d8), K053514 (d8), K061521 (d8), K072221 (d8), K072575 (d8), K123166 (d8), K072415 (d8), K043206 (d8), K133623 (d8), K123206 (d8), K103666 (d8), K133557 (d8), K081968 (d8), K131372 (d8), K140659 (d8), K132999 (d8), K133653 (d8), K132894 (d8), K053340 (d8), K100391 (d8), K072981 (d8), K121982 (d8), K122639 (d8), K142940 (d8), K140759 (d8), K131723 (d8), K120603 (d8), K162138 (d8), K162264 (d8), K171496 (d8)

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

Manufacturer compliance record — Orthofix US LLC

  • VAI 2023-03-17 Orthofix U.S. LLC · 2 citations
  • VAI 2012-09-27 Orthofix Srl · 1 citations
  • VAI 2012-09-27 Orthofix Srl · 1 citations
  • VAI 2011-06-24 Orthofix U.S. LLC · 1 citations
  • NAI 2010-02-23 Orthofix U.S. LLC · 0 citations