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Piccolo Composite Nailing System / CarboClear Pedicle Screw System

Model Mallet · CARBOFIX ORTHOPEDICS LTD · DI 07290109338002

HSB — Rod, Fixation, Intramedullary And Accessories · Class II · 21 CFR 888.3020

NKB — Thoracolumbosacral Pedicle Screw System · Class II · 21 CFR 888.3070

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 (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 1.83/device2019-02: 0 reports for this device; peer average 1.76/device2019-03: 0 reports for this device; peer average 1.76/device2019-04: 0 reports for this device; peer average 1.68/device2019-05: 0 reports for this device; peer average 1.69/device2019-06: 0 reports for this device; peer average 1.98/device2019-07: 0 reports for this device; peer average 1.58/device2019-08: 0 reports for this device; peer average 2.38/device2019-09: 0 reports for this device; peer average 1.55/device2019-10: 0 reports for this device; peer average 1.7/device2019-11: 0 reports for this device; peer average 2.04/device2019-12: 0 reports for this device; peer average 1.55/device2020-01: 0 reports for this device; peer average 2.01/device2020-02: 0 reports for this device; peer average 1.82/device2020-03: 0 reports for this device; peer average 2.03/device2020-04: 0 reports for this device; peer average 1.82/device2020-05: 0 reports for this device; peer average 2.24/device2020-06: 0 reports for this device; peer average 1.98/device2020-07: 0 reports for this device; peer average 2.19/device2020-08: 0 reports for this device; peer average 2.69/device2020-09: 0 reports for this device; peer average 2.3/device2020-10: 0 reports for this device; peer average 2.59/device2020-11: 0 reports for this device; peer average 2.85/device2020-12: 0 reports for this device; peer average 2.82/device2021-01: 0 reports for this device; peer average 2.83/device2021-02: 0 reports for this device; peer average 2.59/device2021-03: 0 reports for this device; peer average 3/device2021-04: 0 reports for this device; peer average 3.02/device2021-05: 0 reports for this device; peer average 3.5/device2021-06: 0 reports for this device; peer average 2.9/device2021-07: 0 reports for this device; peer average 2.38/device2021-08: 0 reports for this device; peer average 2.04/device2021-09: 0 reports for this device; peer average 2.12/device2021-10: 0 reports for this device; peer average 2.07/device2021-11: 0 reports for this device; peer average 2.96/device2021-12: 0 reports for this device; peer average 2.44/device2022-01: 0 reports for this device; peer average 2.69/device2022-02: 0 reports for this device; peer average 2.08/device2022-03: 0 reports for this device; peer average 2.13/device2022-04: 0 reports for this device; peer average 2.25/device2022-05: 0 reports for this device; peer average 1.99/device2022-06: 0 reports for this device; peer average 2.16/device2022-07: 0 reports for this device; peer average 2.86/device2022-08: 0 reports for this device; peer average 1.84/device2022-09: 0 reports for this device; peer average 2.45/device2022-10: 0 reports for this device; peer average 2.07/device2022-11: 0 reports for this device; peer average 2.07/device2022-12: 0 reports for this device; peer average 2.18/device2023-01: 0 reports for this device; peer average 2.08/device2023-02: 0 reports for this device; peer average 2.08/device2023-03: 0 reports for this device; peer average 2.13/device2023-04: 0 reports for this device; peer average 2.21/device2023-05: 0 reports for this device; peer average 2.15/device2023-06: 0 reports for this device; peer average 2.18/device2023-07: 0 reports for this device; peer average 1.97/device2023-08: 0 reports for this device; peer average 1.85/device2023-09: 0 reports for this device; peer average 1.87/device2023-10: 0 reports for this device; peer average 1.89/device2023-11: 0 reports for this device; peer average 1.83/device2023-12: 0 reports for this device; peer average 1.59/device2024-01: 0 reports for this device; peer average 2.13/device2024-02: 0 reports for this device; peer average 1.83/device2024-03: 0 reports for this device; peer average 2.75/device2024-04: 0 reports for this device; peer average 1.52/device2024-05: 0 reports for this device; peer average 2.59/device2024-06: 0 reports for this device; peer average 2.27/device2024-07: 0 reports for this device; peer average 1.6/device2024-08: 0 reports for this device; peer average 1.95/device2024-09: 0 reports for this device; peer average 2.9/device2024-10: 0 reports for this device; peer average 1.93/device2024-11: 0 reports for this device; peer average 1.86/device2024-12: 0 reports for this device; peer average 1.84/device2025-01: 0 reports for this device; peer average 2.02/device2025-02: 0 reports for this device; peer average 2.12/device2025-03: 0 reports for this device; peer average 2.01/device2025-04: 0 reports for this device; peer average 1.93/device2025-05: 0 reports for this device; peer average 1.99/device2025-06: 0 reports for this device; peer average 1.74/device2025-07: 0 reports for this device; peer average 1.68/device2025-08: 0 reports for this device; peer average 1.71/device2025-09: 0 reports for this device; peer average 1.58/device2025-10: 0 reports for this device; peer average 1.66/device2025-11: 0 reports for this device; peer average 1.87/device2025-12: 0 reports for this device; peer average 2.11/device2026-01: 0 reports for this device; peer average 2.04/device2026-02: 0 reports for this device; peer average 1.93/device2026-03: 0 reports for this device; peer average 2.03/device2026-04: 0 reports for this device; peer average 1.73/device2026-05: 0 reports for this device; peer average 1.88/device2026-06: 0 reports for this device; peer average 2.75/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.83
2019-0201.76
2019-0301.76
2019-0401.68
2019-0501.69
2019-0601.98
2019-0701.58
2019-0802.38
2019-0901.55
2019-1001.7
2019-1102.04
2019-1201.55
2020-0102.01
2020-0201.82
2020-0302.03
2020-0401.82
2020-0502.24
2020-0601.98
2020-0702.19
2020-0802.69
2020-0902.3
2020-1002.59
2020-1102.85
2020-1202.82
2021-0102.83
2021-0202.59
2021-0303
2021-0403.02
2021-0503.5
2021-0602.9
2021-0702.38
2021-0802.04
2021-0902.12
2021-1002.07
2021-1102.96
2021-1202.44
2022-0102.69
2022-0202.08
2022-0302.13
2022-0402.25
2022-0501.99
2022-0602.16
2022-0702.86
2022-0801.84
2022-0902.45
2022-1002.07
2022-1102.07
2022-1202.18
2023-0102.08
2023-0202.08
2023-0302.13
2023-0402.21
2023-0502.15
2023-0602.18
2023-0701.97
2023-0801.85
2023-0901.87
2023-1001.89
2023-1101.83
2023-1201.59
2024-0102.13
2024-0201.83
2024-0302.75
2024-0401.52
2024-0502.59
2024-0602.27
2024-0701.6
2024-0801.95
2024-0902.9
2024-1001.93
2024-1101.86
2024-1201.84
2025-0102.02
2025-0202.12
2025-0302.01
2025-0401.93
2025-0501.99
2025-0601.74
2025-0701.68
2025-0801.71
2025-0901.58
2025-1001.66
2025-1101.87
2025-1202.11
2026-0102.04
2026-0201.93
2026-0302.03
2026-0401.73
2026-0501.88
2026-0602.75
This device (reports/month)Average device in HSB, NKB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K091425 — cites (transitively): K013449 (d1), K032588 (d1), K052533 (d1), K983942 (d1) — cited as predicate by K102369, K102597, K111056, K151010

K100497 — cites (transitively): K032523 (d1), K032722 (d1), K042396 (d1), K043404 (d1) — cited as predicate by K102369, K102597, K132774, K151010

K102369 — cites (transitively): K002783 (d1), K003018 (d1), K010801 (d1), K032588 (d1), K061019 (d1), K091425 (d1), K100497 (d1), K983942 (d1), K013449 (d2), K052533 (d2), K032523 (d2), K032722 (d2), K042396 (d2), K043404 (d2) — cited as predicate by K132774, K151010, K153536, K200519

K111056 — cites (transitively): K002783 (d1), K003018 (d1), K013449 (d1), K032588 (d1), K033618 (d1), K091425 (d1), K914453 (d1), K962047 (d1), K965098 (d1), K052533 (d2), K983942 (d2) — cited as predicate by K151010, K153536

K123810 — cited as predicate by K132774, K151010, K163589, K182307, K200519

K151010 — cites (transitively): K010988 (d1), K011857 (d1), K012967 (d1), K043431 (d1), K091425 (d1), K100497 (d1), K102369 (d1), K111056 (d1), K123810 (d1), K132774 (d1), K013449 (d2), K032588 (d2), K052533 (d2), K983942 (d2), K032523 (d2), K032722 (d2), K042396 (d2), K043404 (d2), K002783 (d2), K003018 (d2), K010801 (d2), K061019 (d2), K033618 (d2), K914453 (d2), K962047 (d2), K965098 (d2), K130061 (d2), K000682 (d3), K082807 (d3), K102597 (d3), K120409 (d3), K002775 (d4), K000636 (d4), K073460 (d4), K081284 (d4) — cited as predicate by K153536, K210716

K153536 — cites (transitively): K043431 (d1), K102369 (d1), K111056 (d1), K151010 (d1), K002783 (d2), K003018 (d2), K010801 (d2), K032588 (d2), K061019 (d2), K091425 (d2), K100497 (d2), K983942 (d2), K013449 (d2), K033618 (d2), K914453 (d2), K962047 (d2), K965098 (d2), K010988 (d2), K011857 (d2), K012967 (d2), K123810 (d2), K132774 (d2), K052533 (d3), K032523 (d3), K032722 (d3), K042396 (d3), K043404 (d3), K130061 (d3), K000682 (d4), K082807 (d4), K102597 (d4), K120409 (d4), K002775 (d5), K000636 (d5), K073460 (d5), K081284 (d5)

K173487 — cites (transitively): K052398 (d1), K152604 (d1), K160879 (d1), K170347 (d1), K170543 (d1), K042025 (d2), K113174 (d2), K150460 (d2), K113164 (d2), K162912 (d2), K063736 (d3), K093828 (d3), K102397 (d3), K160904 (d3), K033801 (d4), K041584 (d4), K103490 (d4), K110216 (d4), K111136 (d4), K121020 (d4), K130877 (d4), K131802 (d4), K033901 (d5), K955348 (d5), K063741 (d5), K090648 (d5), K101993 (d5), K102701 (d5), K111571 (d5), K080313 (d6), K011182 (d6), K070387 (d6), K073562 (d6), K102249 (d6), K062174 (d7) — cited as predicate by K182377, K192214, K193378, K200519, K200883, K201251, K201926, K203317, K210716, K232341, K233944

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

Manufacturer compliance record — CARBOFIX ORTHOPEDICS LTD

  • VAI 2017-03-02 CarboFix Orthopedics, Ltd. · 4 citations
  • VAI 2017-03-02 CarboFix Orthopedics, Ltd. · 4 citations