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Pisces-SA

Model 1760-7012 · Osseus Fusion Systems, LLC · DI B06217607012

FZS — Curette, Surgical, General Use · Class I · 21 CFR 878.4800

UDILibrary device dossier · generated 2026-09-15 · 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.

12342019-09: 0 reports for this device; peer average 4/device2020-09: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1.33/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1.5/device2026-05: 0 reports for this device; peer average 2/device09091112060805080911010203040506071112010405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0904
2020-0901
2020-1102
2020-1201
2021-0601
2023-0802
2024-0501
2024-0802
2024-0901
2024-1101
2025-0101.5
2025-0201
2025-0301
2025-0401
2025-0501
2025-0601
2025-0701
2025-1101.33
2025-1201
2026-0101
2026-0401.5
2026-0502
This device (reports/month)Average device in FZS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K213935 — cites (transitively): K153495 (d1), K181347 (d1), K191391 (d1), K192121 (d1), K203742 (d1), K082262 (d2), K090507 (d2), K110327 (d2), K113285 (d2), K142645 (d2), K150643 (d2), K152475 (d2), K072791 (d2), K082698 (d2), K090707 (d2), K091088 (d2), K101302 (d2), K150788 (d2), K160547 (d2), K162264 (d2), K170503 (d2), K172009 (d2), K172941 (d2), P950002 (d2), P950019 (d2), P960025 (d2), K102293 (d2), K160597 (d2), K163361 (d2), K170157 (d2), K170318 (d2), K181357 (d2), K090984 (d2), K091291 (d2), K101278 (d2), K113666 (d2), K131810 (d2), K132412 (d2), K132925 (d2), K142381 (d2), K150896 (d2), K153453 (d2), K940631 (d2), K950099 (d2), K950697 (d2), K954696 (d2), K073109 (d2), K083475 (d2), K102334 (d2), K182139 (d2), K202812 (d2), K022623 (d3), K024096 (d3), K031585 (d3), K031655 (d3), K041460 (d3), K051971 (d3), K974749 (d3), K992168 (d3), K072970 (d3), K093242 (d3), K073514 (d3), K092124 (d3), K103382 (d3), K033352 (d3), K051716 (d3), K071376 (d3), K090648 (d3), K102701 (d3), K072116 (d3), K121342 (d3), K140276 (d3), K133650 (d3), K101301 (d3), K141942 (d3), K123552 (d3), K131980 (d3), K133086 (d3), K133556 (d3), K133746 (d3), K103111 (d3), K121649 (d3), K141953 (d3), K011437 (d3), K133369 (d3), K141376 (d3), K152457 (d3), K110843 (d3), K130699 (d3), K150481 (d3), K082252 (d3), K120101 (d3), K123045 (d3), K160125 (d3), K000682 (d3), K000684 (d3), K011815 (d3), K040112 (d3), K041860 (d3), K041965 (d3), K060290 (d3), K060514 (d3), K063049 (d3), K070946 (d3), K073460 (d3), K082625 (d3), K083032 (d3), K083286 (d3), K092556 (d3), K102694 (d3), K111620 (d3), K112437 (d3), K133668 (d3), K133974 (d3), K140814 (d3), K142906 (d3), K143697 (d3), K153716 (d3), K951303 (d3), K982732 (d3), K142218 (d3), K142397 (d3), K142498 (d3), K143578 (d3), K120275 (d3), K153615 (d3), K080588 (d3), K092193 (d3), K093669 (d3), K112095 (d3), K122588 (d3), K143258 (d3), K141665 (d3), K123767 (d3), K131533 (d3), K131547 (d3), K133614 (d3), K100865 (d3), K102313 (d3), K122097 (d3), K123231 (d3), K130478 (d3), K131276 (d3), K151665 (d3), K152022 (d3), K161223 (d3), K170962 (d3), K171031 (d3), K162236 (d3), K162496 (d3), K163269 (d3), K170953 (d3), K183705 (d3), K200543 (d3), K073643 (d4), K073470 (d4), K080758 (d4), K082014 (d4), K083661 (d4), K093704 (d4), K012694 (d4), K083694 (d4), K073202 (d4), K083626 (d4), K071795 (d4), K051454 (d4), K063399 (d4), K080024 (d4), K080699 (d4), K963798 (d4), K043248 (d4), K052776 (d4), K073285 (d4), K100214 (d4), P980048 (d4), K100889 (d4), K101812 (d4), K113447 (d4), K080537 (d4), K031985 (d4), K052247 (d4), K052566 (d4), K060634 (d4), K062505 (d4), K082032 (d4), K100297 (d4), K121764 (d4), K031302 (d4), K040284 (d4), K072991 (d4), K083389 (d4), K031672 (d4), K103169 (d4), K072253 (d4), K091253 (d4), K972718 (d4), K023644 (d4), K946348 (d4), K041808 (d4), K060990 (d4), K070367 (d4), K073510 (d4), K003780 (d4), K070282 (d4), K071435 (d4), K091689 (d4), K123656 (d4), K991089 (d4), K994187 (d4), K073291 (d4), K121760 (d4), K123027 (d4), K052483 (d4), K121672 (d4), K963172 (d4), K000476 (d4), K003822 (d4), K022285 (d4), K022949 (d4), K082572 (d4), K090203 (d4), K090523 (d4), K091067 (d4), K905826 (d4), K962984 (d4), K040022 (d4), K080667 (d4), K132502 (d4), K091445 (d4), K111457 (d4), K132328 (d4), K132471 (d4), K090675 (d4), K132886 (d4), K090816 (d4), K113348 (d4), K120918 (d4), K130820 (d4), K131082 (d4), K132601 (d4), K133455 (d4), K140319 (d4), K101310 (d4), K102090 (d4), K111122 (d4), K133200 (d4), K133286 (d4), K032812 (d4), K080615 (d4), K083714 (d4), K102067 (d4), K111626 (d4), K140055 (d4), K011084 (d4), K140482 (d4), K051567 (d4), K103332 (d4), K112316 (d4), K060665 (d4), K072465 (d4), K112756 (d4), K121107 (d4), K131449 (d4), K133967 (d4), K101421 (d4), K955472 (d4), K100945 (d4), K113138 (d4), K113561 (d4), K141405 (d4), K100043 (d4), K120368 (d4), K143163 (d4), K113174 (d4), K142591 (d4), K142847 (d4), K142026 (d4), K142345 (d4), K150321 (d4), K001945 (d4), K011978 (d4), K012114 (d4), K021932 (d4), K023802 (d4), K030597 (d4), K030858 (d4), K033975 (d4), K033995 (d4), K040777 (d4), K051986 (d4), K061753 (d4), K062494 (d4), K062564 (d4), K082807 (d4), K092493 (d4), K092812 (d4), K983787 (d4), K133494 (d4), K150362 (d4), K152304 (d4), K140479 (d4), K153419 (d4), K161230 (d4), K094025 (d4), K110543 (d4), K132053 (d4), K132897 (d4), K180480 (d4), K181435 (d4), K182746 (d4), K190546 (d4), K013248 (d5), K020602 (d5), K072832 (d5), K080522 (d5), K052261 (d5), K092336 (d5), P000028 (d5), K080099 (d5), K080518 (d5), K082801 (d5), K080401 (d5), K072083 (d5), K082300 (d5), K073351 (d5), K081917 (d5), K092904 (d5), K033805 (d5), K092038 (d5), K100175 (d5), K083186 (d5), K083894 (d5), K003275 (d5), K041389 (d5), K050850 (d5), K060506 (d5), K031635 (d5), K080568 (d5), K101923 (d5), K033926 (d5), K090353 (d5), K103731 (d5), K090841 (d5), K042695 (d5), K082732 (d5), K042789 (d5), K070742 (d5), K080805 (d5), K082728 (d5), K090714 (d5), K023570 (d5), K062933 (d5), K082310 (d5), K091278 (d5), K100042 (d5), K050439 (d5), K090390 (d5), K091974 (d5), K101074 (d5), K981676 (d5), K000636 (d5), K063875 (d5), K073527 (d5), K100271 (d5), K101056 (d5), K113760 (d5), K130548 (d5), K060736 (d5), K061748 (d5), K062216 (d5), K101240 (d5), K993106 (d5), K072415 (d5), K043206 (d5), K133623 (d5), K092211 (d5), K120031 (d5), K122630 (d5), K130573 (d5), K110632 (d5), K122967 (d5), K080508 (d5), K071724 (d5), K081968 (d5), K100089 (d5), K131372 (d5), K090064 (d5), K110733 (d5), K113518 (d5), K042025 (d5), K052187 (d5), K141494 (d5), K093864 (d5), K101051 (d5), K120869 (d5), K133328 (d5), K141217 (d5), K102957 (d5), K081611 (d5), K140003 (d5), K140921 (d5), K142050 (d5), K142264 (d5), K123486 (d5), K132624 (d5), K143393 (d5), K143616 (d5), K150994 (d5), K151472 (d5), K141896 (d5), K153782 (d5), K160051 (d5), K151256 (d5), K160958 (d5), K161485 (d5), K171633 (d5), K081730 (d5), K120603 (d5), K171140 (d5), K090782 (d5), K101255 (d5), K102402 (d5), K121791 (d5), K143740 (d5), K163543 (d5), K173892 (d5), K181453 (d5), K182747 (d5), K052292 (d5), K120345 (d5), K132029 (d5), K181837 (d5), P110002 (d5), K003836 (d6), K010930 (d6), K090166 (d6), K043479 (d6), P970015 (d6), K083026 (d6), K040593 (d6), K040962 (d6), K050981 (d6), K043548 (d6), K102257 (d6), K073348 (d6), K082260 (d6), K062083 (d6), K042571 (d6), K050624 (d6), K061836 (d6), K062132 (d6), K111123 (d6), K022791 (d6), K052546 (d6), K061353 (d6), K091044 (d6), K080971 (d6), K092070 (d6), K072160 (d6), K092901 (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), K123206 (d6), K140659 (d6), K130177 (d6), K053340 (d6), K100391 (d6), K140531 (d6), K141635 (d6), K131723 (d6), K110442 (d6), K140280 (d6), K141791 (d6), K140770 (d6), K153627 (d6), K163506 (d6), K172123 (d6), K133218 (d6), K150061 (d6), K152011 (d6), K170235 (d6), K091845 (d6), K102673 (d6), K020752 (d7), K020758 (d7), K040449 (d7), K092983 (d7), K042871 (d7), K052888 (d7), K983084 (d7), K050539 (d7), K063423 (d7), K974556 (d7), K071833 (d7), K112036 (d7), K122771 (d7), K081614 (d7), K093950 (d7), K081127 (d7), K121771 (d7), K143595 (d7), K140348 (d7), K143685 (d7), K151128 (d7), K151322 (d7), K103666 (d7), K162327 (d7), K143065 (d7), K153105 (d7), K163230 (d7), K052210 (d8), K101433 (d8), K120370 (d8), K123969 (d8), K132738 (d8), K133126 (d8), K133340 (d8), K021039 (d8), K040130 (d8), K072339 (d8), K072943 (d8), K090415 (d8), K121837 (d8), K133577 (d8), K151374 (d8), K082128 (d8), K110454 (d8), K122896 (d8), K140759 (d8), K151773 (d8) — cited as predicate by K223146, K223413, K231199, K240326, K250845

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

Manufacturer compliance record — Osseus Fusion Systems, LLC

  • NAI 2018-08-24 Osseus Fusion Systems, LLC · 0 citations
  • NAI 2018-08-24 Osseus Fusion Systems, LLC · 0 citations
  • VAI 2015-04-23 Osseus Fusion Systems, LLC · 0 citations
  • VAI 2015-04-23 Osseus Fusion Systems, LLC · 0 citations