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

CORIOGRAPH

Model ROB20032 · Smith & Nephew, Inc. · DI 00885556925379

PBF — Orthopaedic Surgical Planning And Instrument Guides · Class II · 21 CFR 888.3030

UDILibrary device dossier · generated 2026-09-13 · 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.

12342019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 3/device2020-01: 0 reports for this device; peer average 4/device2020-07: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 2.67/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1/device1112010709040506030607111205100508100811120304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1101
2019-1203
2020-0104
2020-0701
2020-0902
2021-0401
2021-0501
2021-0601
2022-0302
2022-0601
2022-0702.67
2022-1101
2022-1201
2023-0501
2023-1001
2024-0501
2024-0801
2024-1001
2025-0802
2025-1101
2025-1201
2026-0301
2026-0401
This device (reports/month)Average device in PBF (reports/device/month)

Regulatory clearances

  • K250921 SESE 2025-06-25 (k number procode)

Predicate lineage

K250921 — cites (transitively): K021673 (d1), K070756 (d1), K073325 (d1), K091543 (d1), K093746 (d1), K100897 (d1), K102069 (d1), K111711 (d1), K121443 (d1), K141471 (d1), K142807 (d1), K152726 (d1), K180334 (d1), K191211 (d1), K203175 (d1), K210566 (d1), K211176 (d1), K211221 (d1), K220959 (d1), K230572 (d1), K232667 (d1), K240381 (d1), K242272 (d1), K242813 (d1), K951987 (d1), K962557 (d1), K963509 (d1), K970351 (d1), K071071 (d2), K030623 (d2), K032683 (d2), K061011 (d2), K912735 (d2), K032295 (d2), K042515 (d2), K101499 (d2), K113482 (d2), K041825 (d2), K904448 (d2), K112941 (d2), K043440 (d2), K081111 (d2), K162775 (d2), K160738 (d2), K190085 (d2), K130728 (d2), K002747 (d2), K002996 (d2), K021803 (d2), K022556 (d2), K022902 (d2), K022958 (d2), K023302 (d2), K023743 (d2), K033442 (d2), K040680 (d2), K052792 (d2), K070278 (d2), K071160 (d2), K072817 (d2), K072852 (d2), K081124 (d2), K083566 (d2), K083762 (d2), K092386 (d2), K093363 (d2), K093991 (d2), K100412 (d2), K100481 (d2), K102370 (d2), K103256 (d2), K110101 (d2), K110135 (d2), K113848 (d2), K120211 (d2), K121627 (d2), K122244 (d2), K122296 (d2), K123012 (d2), K143739 (d2), K150790 (d2), K151902 (d2), K160923 (d2), K162303 (d2), K171073 (d2), K171934 (d2), K182109 (d2), K182535 (d2), K791125 (d2), K823723 (d2), K823727 (d2), K831884 (d2), K896580 (d2), K900628 (d2), K914878 (d2), K920430 (d2), K921400 (d2), K932755 (d2), K934353 (d2), K960094 (d2), K962541 (d2), K963486 (d2), K970337 (d2), K971414 (d2), K983834 (d2), K990369 (d2), K990666 (d2), K991485 (d2), K033363 (d2), K132624 (d2), K181366 (d2), K953274 (d2), K191002 (d2), K052906 (d2), K130050 (d2), K130129 (d2), K142139 (d2), K152047 (d2), K172351 (d2), K181999 (d2), K200171 (d2), K201315 (d2), K210717 (d2), K220847 (d2), K994146 (d2), K212040 (d2), K240113 (d2), K051075 (d2), K052472 (d2), K062250 (d2), K080402 (d2), K092122 (d2), K092873 (d2), K100448 (d2), K100858 (d2), K110598 (d2), K111629 (d2), K112438 (d2), K113254 (d2), K120174 (d2), K130642 (d2), K131559 (d2), K133349 (d2), K142413 (d2), K143256 (d2), K153602 (d2), K161189 (d2), K162024 (d2), K170893 (d2), K172054 (d2), K173717 (d2), K183077 (d2), K190286 (d2), K193560 (d2), K202716 (d2), K203694 (d2), K212569 (d2), K212737 (d2), K212933 (d2), K213387 (d2), K220452 (d2), K220792 (d2), K221467 (d2), K222427 (d2), K222592 (d2), K230315 (d2), K230831 (d2), K231112 (d2), K233408 (d2), K233481 (d2), K241143 (d2), K061253 (d3), K062408 (d3), K071535 (d3), K082844 (d3), K032126 (d3), K063578 (d3), K962082 (d3), K030259 (d3), K992525 (d3), K023211 (d3), K040267 (d3), K062654 (d3), K062148 (d3), K083116 (d3), K022204 (d3), K051229 (d3), K946236 (d3), K111863 (d3), K031729 (d3), K042883 (d3), K042993 (d3), K051146 (d3), K051380 (d3), K051977 (d3), K053514 (d3), K061521 (d3), K072221 (d3), K072575 (d3), K123166 (d3), K123486 (d3), K053274 (d3), K081016 (d3), K091751 (d3), K101263 (d3), K111212 (d3), K113523 (d3), K030710 (d3), K050937 (d3), K060630 (d3), K113789 (d3), K103007 (d3), K130895 (d3), K112144 (d3), K113413 (d3), K123982 (d3), K140904 (d3), K042127 (d3), K052426 (d3), K954935 (d3), K961939 (d3), K102019 (d3), P040033 (d3), K112069 (d3), K162800 (d3), K100741 (d3), K111061 (d3), K111735 (d3), K141006 (d3), K141990 (d3), K072121 (d3), K150522 (d3), K111635 (d3), K122139 (d3), K162641 (d3), K030941 (d3), K061439 (d3), K081059 (d3), K140478 (d3), K151293 (d3), K152315 (d3), K183039 (d3), K161233 (d3), K161742 (d3), K172502 (d3), K191746 (d3), K191963 (d3), K190521 (d3), K060692 (d3), K060694 (d3), K060716 (d3), K091196 (d3), K111596 (d3), K121183 (d3), K122698 (d3), K905786 (d3), K170748 (d3), K183696 (d3), K192855 (d3), K173380 (d3), K173390 (d3), K071379 (d3), K081620 (d3), K130048 (d3), K181611 (d3), K193373 (d3), K203108 (d3), K150583 (d3), K203026 (d3), K950651 (d3), K163397 (d3), K190911 (d3), K201905 (d3), K063569 (d3), K121543 (d3), K160975 (d3), K190588 (d3), K202611 (d3), K212800 (d3), K103419 (d3), K111379 (d3), K121220 (d3), K130390 (d3), K182039 (d3), K041066 (d3), K211512 (d3), K221224 (d3), K240139 (d3), K061067 (d4), K060988 (d4), K073331 (d4), K042021 (d4), K061454 (d4), K093430 (d4), K102670 (d4), K982981 (d4), K030047 (d4), K030055 (d4), K031454 (d4), K042989 (d4), K050124 (d4), K052996 (d4), K070369 (d4), K073449 (d4), K102795 (d4), K110555 (d4), K810120 (d4), K861114 (d4), K861433 (d4), K911685 (d4), K920639 (d4), K920640 (d4), K921181 (d4), K921277 (d4), K921301 (d4), K926107 (d4), K954417 (d4), K970501 (d4), K991990 (d4), K071147 (d4), P960054 (d4), K050539 (d4), K063423 (d4), K974556 (d4), K072160 (d4), K082120 (d4), K103208 (d4), K950594 (d4), K030555 (d4), K101336 (d4), K103233 (d4), K121874 (d4), K140669 (d4), K974558 (d4), K050316 (d4), K100142 (d4), K132285 (d4), K140082 (d4), K081351 (d4), K081566 (d4), K110708 (d4), K033273 (d4), P960047 (d4), K101342 (d4), K111902 (d4), K132636 (d4), K160001 (d4), K160555 (d4), K071090 (d4), K153722 (d4), K060704 (d4), K101996 (d4), K133834 (d4), K080642 (d4), K120121 (d4), K131353 (d4), K001448 (d4), K010757 (d4), K052718 (d4), K091508 (d4), K103479 (d4), K111546 (d4), K112802 (d4), K120370 (d4), K122158 (d4), K161569 (d4), K161479 (d4), K013991 (d4), K113069 (d4), K133378 (d4), K161120 (d4), K162068 (d4), K172371 (d4), K172634 (d4), K180612 (d4), K181742 (d4), K141934 (d4), K113121 (d4), K132239 (d4), K152754 (d4), K131112 (d4), K172456 (d4), K162455 (d4), K173900 (d4), K190290 (d4), K193372 (d4), K013042 (d4), K083439 (d4), K143552 (d4), K171858 (d4), K173388 (d4), K182516 (d4), K183194 (d4), K193226 (d4), K170282 (d4), K173970 (d4), K200826 (d4), K173073 (d4), K123380 (d4), K200888 (d4), K201022 (d4), K220255 (d4), K041106 (d4), K060742 (d4), K190439 (d4), K222653 (d4), K231963 (d4), K042037 (d5), K050327 (d5), K062995 (d5), K070364 (d5), K070399 (d5), K072020 (d5), K093644 (d5), K100048 (d5), K063470 (d5), K093533 (d5), K032396 (d5), K042051 (d5), K001733 (d5), K022520 (d5), K050262 (d5), K061066 (d5), K062978 (d5), K101670 (d5), K993352 (d5), K994078 (d5), K060209 (d5), K063081 (d5), K952928 (d5), K994392 (d5), K010170 (d5), K041906 (d5), K042842 (d5), K094035 (d5), K102487 (d5), K103662 (d5), K093235 (d5), K101072 (d5), K971206 (d5), K082081 (d5), K073468 (d5), K102975 (d5), K122770 (d5), K122798 (d5), K033260 (d5), K093552 (d5), K110847 (d5), K073714 (d5), K142923 (d5), K112898 (d5), K143374 (d5), K142671 (d5), K081171 (d5), K142606 (d5), K151264 (d5), K152304 (d5), K903362 (d5), K943549 (d5), K944213 (d5), K983382 (d5), K093599 (d5), K112193 (d5), K142778 (d5), K150488 (d5), K130708 (d5), K142863 (d5), K141395 (d5), K161863 (d5), K131298 (d5), K140063 (d5), K153595 (d5), K110415 (d5), K172650 (d5), K173445 (d5), P010014 (d5), K071881 (d5), K150307 (d5), K172326 (d5), K172210 (d5), K071032 (d5), K052567 (d5), K133811 (d5), K142066 (d5), K183010 (d5), K113060 (d5), K163338 (d5), K170808 (d5), K173884 (d5), K183533 (d5), K191223 (d5), K193120 (d5), K212537 (d5), K231292 (d5), K002379 (d6), K082358 (d6), K992065 (d6), K051588 (d6), K073102 (d6), K935484 (d6), K950827 (d6), K080528 (d6), K090103 (d6), K043079 (d6), K090982 (d6), K070479 (d6), K101229 (d6), K000575 (d6), K021891 (d6), K072154 (d6), K850766 (d6), K851213 (d6), K934765 (d6), K953490 (d6), K974093 (d6), K974095 (d6), K070592 (d6), K023096 (d6), K033810 (d6), K082172 (d6), K090763 (d6), K133039 (d6), K082014 (d6), K113285 (d6), K120869 (d6), K131276 (d6), K133328 (d6), K013676 (d6), K103251 (d6), K112389 (d6), K130126 (d6), K131129 (d6), K123814 (d6), K130759 (d6), K140071 (d6), K142462 (d6), K060506 (d6), K143393 (d6), K143616 (d6), K062113 (d6), K103835 (d6), K090953 (d6), K132104 (d6), K150372 (d6), K113606 (d6), K062037 (d6), K070095 (d6), K141056 (d6), K112301 (d6), K161559 (d6), K162273 (d6), K140027 (d6), K172336 (d6), K080802 (d6), K142388 (d6), K180271 (d6), K193307 (d6), K011815 (d6), K041860 (d6), K082807 (d6), K101056 (d6), K120070 (d6), K120689 (d6), K213864 (d6), K073527 (d7), K093846 (d7), K950521 (d7), K990598 (d7), K082262 (d7), K090507 (d7), K103382 (d7), K000682 (d7), K052390 (d7), K083286 (d7), K073470 (d7), K060874 (d7), K111097 (d7), K050897 (d7), K123122 (d7), K072253 (d7), P950002 (d7), K070108 (d7), K113369 (d7), K113829 (d7), K121640 (d7), K122745 (d7), K042067 (d7), K120313 (d7), K122500 (d7), K131368 (d7), K905258 (d7), K053340 (d7), K100391 (d7), K090474 (d7), K130380 (d7), K131767 (d7), K003746 (d7), K110332 (d7), K120238 (d7), K150928 (d7), K170360 (d7), K092467 (d7), K122011 (d7), K183605 (d7), K051567 (d7), K073186 (d7), K082624 (d7), K092247 (d7), K111540 (d7), K142906 (d7), K203002 (d7), K082060 (d8), K042871 (d8), K052888 (d8), K071795 (d8), K082252 (d8), K093242 (d8), K000684 (d8), K060370 (d8), K073286 (d8), K933785 (d8), K936159 (d8), K960279 (d8), K111492 (d8), K101505 (d8), K063028 (d8), K083483 (d8), K042271 (d8), K072619 (d8), K991581 (d8), K040022 (d8), K070946 (d8), K103332 (d8), K001456 (d8), K102927 (d8), K110950 (d8), K133162 (d8), K143725 (d8), K932837 (d8), K945589 (d8), K954818 (d8), K962215 (d8), K983004 (d8), K121936 (d8), K140596 (d8), K143668 (d8), K152574 (d8), K160537 (d8), K083310 (d8), K011335 (d8)

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

Manufacturer compliance record — Smith & Nephew, Inc.

  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2015-04-30 Smith & Nephew Inc.
  • Warning Letter 2014-06-11 Smith & Nephew, Inc.
  • Warning Letter 2010-09-16 Ascension Orthopedics, Inc
  • NAI 2025-01-27 Integrity Orthopaedics Inc · 0 citations
  • NAI 2023-05-03 CARTIHEAL, LTD · 0 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • VAI 2021-12-09 Smith & Nephew, Inc. · 1 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • NAI 2021-10-26 Smith & Nephew Inc. · 0 citations
  • VAI 2020-02-06 Blue Belt Technologies, Inc · 6 citations
  • NAI 2019-10-25 Tusker Medical, Inc. · 0 citations
  • VAI 2019-10-08 Tusker Medical, Inc. · 3 citations
  • NAI 2018-03-30 Ascension Orthopedics, Inc · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-02-02 Smith & Nephew, Inc. · 0 citations
  • NAI 2018-01-30 Smith & Nephew · 0 citations
  • NAI 2017-08-21 Smith & Nephew, Inc. Advanced Surgical Devices Division · 0 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • VAI 2017-08-02 Smith & Nephew, Inc. · 3 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-07-24 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations
  • NAI 2017-05-25 Smith & Nephew, Inc. · 0 citations