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

Ascend

Model 157-PRO-16R-240000-S · ALPHATEC SPINE, INC. · DI 00190376657400

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

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/device2019-02: 0 reports for this device; peer average 1.38/device2019-03: 0 reports for this device; peer average 2.14/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1.57/device2019-06: 0 reports for this device; peer average 2.14/device2019-07: 0 reports for this device; peer average 1.36/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1.4/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.64/device2020-01: 0 reports for this device; peer average 1.57/device2020-02: 0 reports for this device; peer average 1.2/device2020-03: 0 reports for this device; peer average 1.43/device2020-04: 0 reports for this device; peer average 1.25/device2020-05: 0 reports for this device; peer average 1.2/device2020-06: 0 reports for this device; peer average 1.33/device2020-07: 0 reports for this device; peer average 2.5/device2020-08: 0 reports for this device; peer average 1.45/device2020-09: 0 reports for this device; peer average 1.62/device2020-10: 0 reports for this device; peer average 1.67/device2020-11: 0 reports for this device; peer average 1.13/device2020-12: 0 reports for this device; peer average 1.5/device2021-01: 0 reports for this device; peer average 1.31/device2021-02: 0 reports for this device; peer average 1.33/device2021-03: 0 reports for this device; peer average 1.78/device2021-04: 0 reports for this device; peer average 1.47/device2021-05: 0 reports for this device; peer average 1.29/device2021-06: 0 reports for this device; peer average 2.69/device2021-07: 0 reports for this device; peer average 1.58/device2021-08: 0 reports for this device; peer average 1.64/device2021-09: 0 reports for this device; peer average 1.38/device2021-10: 0 reports for this device; peer average 1.67/device2021-11: 0 reports for this device; peer average 1.44/device2021-12: 0 reports for this device; peer average 1.45/device2022-01: 0 reports for this device; peer average 1.38/device2022-02: 0 reports for this device; peer average 1.59/device2022-03: 0 reports for this device; peer average 1.67/device2022-04: 0 reports for this device; peer average 1.64/device2022-05: 0 reports for this device; peer average 1.79/device2022-06: 0 reports for this device; peer average 1.64/device2022-07: 0 reports for this device; peer average 1.44/device2022-08: 0 reports for this device; peer average 1.4/device2022-09: 0 reports for this device; peer average 2.29/device2022-10: 0 reports for this device; peer average 1.5/device2022-11: 0 reports for this device; peer average 1.8/device2022-12: 0 reports for this device; peer average 1.33/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 1.44/device2023-03: 0 reports for this device; peer average 3/device2023-04: 0 reports for this device; peer average 1.17/device2023-05: 0 reports for this device; peer average 1.31/device2023-06: 0 reports for this device; peer average 1.25/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.63/device2023-09: 0 reports for this device; peer average 1.63/device2023-10: 0 reports for this device; peer average 1.67/device2023-11: 0 reports for this device; peer average 1.22/device2023-12: 0 reports for this device; peer average 1.37/device2024-01: 0 reports for this device; peer average 1.8/device2024-02: 0 reports for this device; peer average 1.75/device2024-03: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1.56/device2024-05: 0 reports for this device; peer average 2.25/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 0 reports for this device; peer average 1.62/device2024-08: 0 reports for this device; peer average 1.07/device2024-09: 0 reports for this device; peer average 1.55/device2024-10: 0 reports for this device; peer average 1.29/device2024-11: 0 reports for this device; peer average 1.38/device2024-12: 0 reports for this device; peer average 1.47/device2025-01: 0 reports for this device; peer average 1.38/device2025-02: 0 reports for this device; peer average 1.75/device2025-03: 0 reports for this device; peer average 3.63/device2025-04: 0 reports for this device; peer average 1.67/device2025-05: 0 reports for this device; peer average 2.2/device2025-06: 0 reports for this device; peer average 1.54/device2025-07: 0 reports for this device; peer average 1.45/device2025-08: 0 reports for this device; peer average 1.71/device2025-09: 0 reports for this device; peer average 1.56/device2025-10: 0 reports for this device; peer average 1.56/device2025-11: 0 reports for this device; peer average 1.53/device2025-12: 0 reports for this device; peer average 1.57/device2026-01: 0 reports for this device; peer average 1.4/device2026-02: 0 reports for this device; peer average 1.18/device2026-03: 0 reports for this device; peer average 1.9/device2026-04: 0 reports for this device; peer average 1.8/device2026-05: 0 reports for this device; peer average 1.67/device2026-06: 0 reports for this device; peer average 1.75/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0201.38
2019-0302.14
2019-0401
2019-0501.57
2019-0602.14
2019-0701.36
2019-0802
2019-0901
2019-1001.4
2019-1101
2019-1201.64
2020-0101.57
2020-0201.2
2020-0301.43
2020-0401.25
2020-0501.2
2020-0601.33
2020-0702.5
2020-0801.45
2020-0901.62
2020-1001.67
2020-1101.13
2020-1201.5
2021-0101.31
2021-0201.33
2021-0301.78
2021-0401.47
2021-0501.29
2021-0602.69
2021-0701.58
2021-0801.64
2021-0901.38
2021-1001.67
2021-1101.44
2021-1201.45
2022-0101.38
2022-0201.59
2022-0301.67
2022-0401.64
2022-0501.79
2022-0601.64
2022-0701.44
2022-0801.4
2022-0902.29
2022-1001.5
2022-1101.8
2022-1201.33
2023-0102
2023-0201.44
2023-0303
2023-0401.17
2023-0501.31
2023-0601.25
2023-0702
2023-0801.63
2023-0901.63
2023-1001.67
2023-1101.22
2023-1201.37
2024-0101.8
2024-0201.75
2024-0302
2024-0401.56
2024-0502.25
2024-0601.5
2024-0701.62
2024-0801.07
2024-0901.55
2024-1001.29
2024-1101.38
2024-1201.47
2025-0101.38
2025-0201.75
2025-0303.63
2025-0401.67
2025-0502.2
2025-0601.54
2025-0701.45
2025-0801.71
2025-0901.56
2025-1001.56
2025-1101.53
2025-1201.57
2026-0101.4
2026-0201.18
2026-0301.9
2026-0401.8
2026-0501.67
2026-0601.75
This device (reports/month)Average device in MQP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K232173 — cites (transitively): K050553 (d1), K161363 (d1), K180480 (d1), K192117 (d1), K192938 (d1), K193506 (d1), K211805 (d1), K222028 (d1), K222973 (d1), K100685 (d2), K133221 (d2), K142591 (d2), K143149 (d2), K152968 (d2), K080699 (d2), K151256 (d2), K160958 (d2), K161485 (d2), K171633 (d2), K012254 (d2), K173982 (d2), K841189 (d2), K180210 (d2), K181677 (d2), K191311 (d2), K142205 (d2), K151651 (d2), K192760 (d2), K181435 (d2), K183705 (d2), K201614 (d2), K202587 (d2), K203201 (d2), K182746 (d2), K210497 (d2), K214010 (d2), K220782 (d2), K172676 (d2), K192582 (d2), K211258 (d2), K033090 (d3), K071890 (d3), K003836 (d3), K030349 (d3), K032476 (d3), K061891 (d3), K090176 (d3), K031655 (d3), K042025 (d3), K052187 (d3), K141494 (d3), K140531 (d3), K141635 (d3), K081611 (d3), K013440 (d3), K142798 (d3), K143740 (d3), K150994 (d3), K110442 (d3), K133614 (d3), K140280 (d3), K071795 (d3), K140770 (d3), K141665 (d3), K153627 (d3), K161230 (d3), K170962 (d3), K120603 (d3), K140003 (d3), K162138 (d3), K163230 (d3), K163491 (d3), K081730 (d3), K141376 (d3), K150362 (d3), K171140 (d3), P980048 (d3), K131802 (d3), K160775 (d3), K090782 (d3), K101255 (d3), K102402 (d3), K121791 (d3), K163543 (d3), K173892 (d3), K181453 (d3), K182747 (d3), K131025 (d3), K142299 (d3), K150053 (d3), K140479 (d3), K172123 (d3), K101225 (d3), K170392 (d3), K182139 (d3), K183064 (d3), K190025 (d3), K160646 (d3), K153419 (d3), K170592 (d3), K172341 (d3), K173153 (d3), K181386 (d3), K181860 (d3), K193541 (d3), K193593 (d3), K200953 (d3), K201820 (d3), K142488 (d3), K171046 (d3), K173260 (d3), K173606 (d3), K181079 (d3), K183083 (d3), K190655 (d3), K192132 (d3), K193636 (d3), K200879 (d3), K201193 (d3), K192018 (d3), K201605 (d3), K073291 (d3), K094025 (d3), K123027 (d3), K171689 (d3), K212524 (d3), K202812 (d3), K202889 (d3), K203742 (d3), K052261 (d4), P950019 (d4), P960025 (d4), K925765 (d4), K944964 (d4), K961728 (d4), K043548 (d4), K072791 (d4), K073202 (d4), K080401 (d4), K080537 (d4), K100214 (d4), K111123 (d4), K022791 (d4), K052546 (d4), K061353 (d4), K091044 (d4), K082732 (d4), K000536 (d4), K053581 (d4), K111136 (d4), K082698 (d4), K101302 (d4), K103169 (d4), K123206 (d4), K081614 (d4), K103382 (d4), K123045 (d4), K093950 (d4), K091974 (d4), K140276 (d4), K081127 (d4), K121771 (d4), K090816 (d4), K113348 (d4), K120918 (d4), K123231 (d4), K130820 (d4), K131082 (d4), K132601 (d4), K133455 (d4), K140319 (d4), K092521 (d4), K102547 (d4), K132894 (d4), K140921 (d4), K082309 (d4), K082310 (d4), K082712 (d4), K102026 (d4), K103297 (d4), K112986 (d4), K123138 (d4), K110632 (d4), K142050 (d4), K142264 (d4), K140659 (d4), K151472 (d4), K143595 (d4), K082466 (d4), K082644 (d4), K123913 (d4), K061202 (d4), K132049 (d4), K141896 (d4), K153782 (d4), K160051 (d4), K160916 (d4), K150481 (d4), K152304 (d4), K141791 (d4), K051859 (d4), K072570 (d4), K081653 (d4), K092035 (d4), K120414 (d4), K151322 (d4), K162715 (d4), K120345 (d4), K160125 (d4), K121332 (d4), K121333 (d4), K122037 (d4), K133205 (d4), K151128 (d4), K160547 (d4), K162358 (d4), K143065 (d4), K153105 (d4), K163506 (d4), K162351 (d4), K073109 (d4), K080822 (d4), K101301 (d4), K101310 (d4), K121211 (d4), K100043 (d4), K140348 (d4), K162236 (d4), K162496 (d4), K163269 (d4), K091845 (d4), K102673 (d4), K180078 (d4), K032064 (d4), K050058 (d4), K101363 (d4), K111675 (d4), K161081 (d4), K170569 (d4), K172926 (d4), K173722 (d4), K021932 (d4), K150321 (d4), K171595 (d4), K141953 (d4), K153122 (d4), K170399 (d4), K173535 (d4), K183557 (d4), K190959 (d4), K152943 (d4), K200885 (d4), K201267 (d4), K201646 (d4), K172888 (d4), K181644 (d4), K183447 (d4), K170953 (d4), K200543 (d4), K110574 (d4), K121302 (d4), K133785 (d4), K151019 (d4), K151983 (d4), K163007 (d4), K170767 (d4), K193468 (d4), K083475 (d4), K102334 (d4), K091813 (d4), K123047 (d4), K132897 (d4), K133577 (d4), K152277 (d4), K201189 (d4), K210425 (d4), K020752 (d5), K020758 (d5), K040449 (d5), K092983 (d5), K073285 (d5), K091088 (d5), K092336 (d5), P000028 (d5), K080588 (d5), K073514 (d5), K092124 (d5), K983084 (d5), K081917 (d5), K082252 (d5), K093242 (d5), K033740 (d5), K063506 (d5), K071724 (d5), K073348 (d5), K031635 (d5), K080568 (d5), K101923 (d5), K042571 (d5), K050624 (d5), K061836 (d5), K062132 (d5), K082014 (d5), K063286 (d5), K072624 (d5), K080396 (d5), K081666 (d5), K083496 (d5), K083805 (d5), K091239 (d5), K101005 (d5), K101849 (d5), K120338 (d5), K974738 (d5), K980698 (d5), K101433 (d5), K120370 (d5), K030327 (d5), K083026 (d5), K094042 (d5), K053008 (d5), K954451 (d5), K043479 (d5), K072970 (d5), K023570 (d5), K062933 (d5), K091278 (d5), K092193 (d5), K100042 (d5), K031585 (d5), K102204 (d5), K111502 (d5), K983583 (d5), K130548 (d5), K073351 (d5), K103033 (d5), K111119 (d5), K112388 (d5), K090353 (d5), K100175 (d5), K043206 (d5), K133623 (d5), K112405 (d5), K113528 (d5), K122591 (d5), K091445 (d5), K111457 (d5), K132328 (d5), K132471 (d5), K122967 (d5), K123969 (d5), K132738 (d5), K133126 (d5), K133340 (d5), K123767 (d5), K131547 (d5), K032812 (d5), K080615 (d5), K083714 (d5), K100889 (d5), K102067 (d5), K111626 (d5), K140055 (d5), K130177 (d5), K021039 (d5), K040130 (d5), K072339 (d5), K072943 (d5), K090415 (d5), K121837 (d5), K102957 (d5), K120368 (d5), K100945 (d5), K110843 (d5), K112316 (d5), K113138 (d5), K113561 (d5), K130699 (d5), K141405 (d5), K133650 (d5), K032413 (d5), K070169 (d5), K072707 (d5), K110789 (d5), K122860 (d5), K151382 (d5), K931271 (d5), K071416 (d5), K091442 (d5), K131669 (d5), K150135 (d5), K991460 (d5), K060506 (d5), K123486 (d5), K132624 (d5), K143393 (d5), K143616 (d5), K151214 (d5), K151374 (d5), K142940 (d5), K151596 (d5), K131723 (d5), K143163 (d5), K072991 (d5), K133494 (d5), K151939 (d5), K161379 (d5), K100089 (d5), K150673 (d5), K151276 (d5), K151773 (d5), K143685 (d5), K946173 (d5), K000080 (d5), K024060 (d5), K082792 (d5), K091967 (d5), K112028 (d5), K130092 (d5), K962011 (d5), K170503 (d5), K102323 (d5), K142589 (d5), K148529 (d5), K121049 (d5), K130478 (d5), K143578 (d5), K150619 (d5), K153373 (d5), K161442 (d5), K161888 (d5), K181014 (d5), K170676 (d5), K171686 (d5), K180364 (d5), K161876 (d5), K190546 (d5), K072407 (d5), K171538 (d5), K170011 (d5), K142559 (d5), K191581 (d5), K131425 (d5), K133216 (d5), K150231 (d5), K163581 (d5), K171031 (d5), K014072 (d6), K050966 (d6), K072857 (d6), K073337 (d6), K082468 (d6), K982447 (d6), K073643 (d6), P950002 (d6), P970015 (d6), K082801 (d6), K070833 (d6), K040166 (d6), K082500 (d6), K933785 (d6), K943462 (d6), K961685 (d6), K024096 (d6), K102257 (d6), K070754 (d6), K093772 (d6), K051454 (d6), K063399 (d6), K080024 (d6), K083626 (d6), K083894 (d6), K083389 (d6), K033926 (d6), K103731 (d6), K103662 (d6), K040721 (d6), K051665 (d6), K070775 (d6), K092146 (d6), K051165 (d6), K072160 (d6), K090064 (d6), K031302 (d6), K040284 (d6), K102293 (d6), K092901 (d6), K031672 (d6), K124004 (d6), K690353 (d6), K050439 (d6), K090390 (d6), K101074 (d6), K981676 (d6), K031729 (d6), K040267 (d6), K042883 (d6), K042993 (d6), K051146 (d6), K051380 (d6), K051977 (d6), K053514 (d6), K061521 (d6), K072221 (d6), K072575 (d6), K123166 (d6), K073470 (d6), K090566 (d6), K121693 (d6), K073669 (d6), K090899 (d6), K100305 (d6), K101051 (d6), K111166 (d6), K092211 (d6), K120031 (d6), K122630 (d6), K121760 (d6), K081968 (d6), K131372 (d6), K113447 (d6), K072415 (d6), K113252 (d6), K113559 (d6), K120819 (d6), K083661 (d6), K093704 (d6), K093864 (d6), K100865 (d6), K120869 (d6), K133328 (d6), K141217 (d6), K053340 (d6), K100391 (d6), K060665 (d6), K072465 (d6), K102313 (d6), K112756 (d6), K120101 (d6), K121107 (d6), K122097 (d6), K131449 (d6), K133967 (d6), K133218 (d6), K142450 (d6), K140454 (d6), K142152 (d6), K072253 (d6), K072981 (d6), K121982 (d6), K122639 (d6), K131276 (d6), K141942 (d6), K140162 (d6), K143126 (d6), K140759 (d6), K100967 (d6), K111264 (d6), K132584 (d6), K150581 (d6), K141135 (d6), K050438 (d6), K153660 (d6), K093669 (d6), K112095 (d6), K122588 (d6), K143258 (d6), K110543 (d6), K132053 (d6), K120570 (d6), K153107 (d6), K162103 (d6), K120275 (d6), K162264 (d6), K171496 (d6), K160955 (d6), K052292 (d6), K132029 (d6), K181837 (d6), P110002 (d6), K082262 (d7), K090166 (d7), K052533 (d7), K080349 (d7), K042871 (d7), K052888 (d7), K080758 (d7), K040962 (d7), K050981 (d7), K101229 (d7), K093093 (d7), K003275 (d7), K041389 (d7), K050850 (d7), K062083 (d7), K091426 (d7), K071833 (d7), K090841 (d7), K080971 (d7), K092070 (d7), K090507 (d7), K050539 (d7), K063423 (d7), K974556 (d7), K132594 (d7), K112036 (d7), K122771 (d7), K130573 (d7), K001340 (d7), K023835 (d7), K030833 (d7), K052746 (d7), K073649 (d7), K082128 (d7), K110454 (d7), K110694 (d7), K081888 (d7), K103666 (d7), K133557 (d7), K102090 (d7), K111122 (d7), K133200 (d7), K133286 (d7), K101812 (d7), K121649 (d7), K132999 (d7), K133653 (d7), K140417 (d7), K142095 (d7), K103111 (d7), K935481 (d7), K100210 (d7), K120991 (d7), K123997 (d7), K140142 (d7), K150216 (d7), K992927 (d7), K153495 (d7), K101171 (d7), K142251 (d7), K152532 (d7), K160924 (d7), K162262 (d7), K150061 (d7), K152011 (d7), K170235 (d7), K073177 (d8), K090425 (d8), K091508 (d8), K093846 (d8), K092904 (d8), K052210 (d8), K083186 (d8), K083447 (d8), K102606 (d8), K062151 (d8), K140106 (d8), K120486 (d8), K142066 (d8), K110327 (d8), K113285 (d8), K142645 (d8), K150643 (d8), K152475 (d8), K150788 (d8), K151310 (d8), K151726 (d8), K162327 (d8)

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

Manufacturer compliance record — ALPHATEC SPINE, INC.

  • Warning Letter 2015-07-16 Alphatec Spine, Inc.
  • Warning Letter 2011-01-11 Alphatec Spine, Inc.
  • Warning Letter 2010-06-21 Alphatec Spine, Inc.
  • VAI 2017-04-19 Alphatec Spine, Inc. · 1 citations
  • VAI 2016-03-16 Alphatec Spine, Inc. · 1 citations
  • OAI 2015-03-13 Alphatec Spine, Inc. · 0 citations
  • NAI 2013-06-14 Alphatec Spine, Inc. · 0 citations
  • VAI 2012-04-27 Alphatec Spine, Inc. · 0 citations
  • VAI 2010-12-13 Alphatec Spine, Inc. · 7 citations
  • OAI 2010-02-11 Alphatec Spine, Inc. · 11 citations