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iDuo® Patella Trial

Model 1080-404 · Conformis, Inc. · DI 00850268007385

NPJ — Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (3)

InitiatedRecall #ClassStatusReasonLink basis
2015-08-31Z-0142-2016Class IITerminatedMay contain small amounts of ethylene glycol residuek number procode
2015-08-31Z-0143-2016Class IITerminatedMay contain small amounts of ethylene glycol residuek number procode
2015-08-31Z-0148-2016Class IITerminatedMay contain small amounts of ethylene glycol residuek number procode

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.

12352019-01: 0 reports for this device; peer average 1.64/device2019-02: 0 reports for this device; peer average 1.33/device2019-03: 0 reports for this device; peer average 1.5/device2019-04: 0 reports for this device; peer average 1.5/device2019-05: 0 reports for this device; peer average 1.75/device2019-06: 0 reports for this device; peer average 1.8/device2019-07: 0 reports for this device; peer average 1.57/device2019-08: 0 reports for this device; peer average 1.33/device2019-09: 0 reports for this device; peer average 1.5/device2019-10: 0 reports for this device; peer average 1.5/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 1.17/device2020-02: 0 reports for this device; peer average 1.43/device2020-03: 0 reports for this device; peer average 2.2/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2.14/device2020-07: 0 reports for this device; peer average 3.2/device2020-08: 0 reports for this device; peer average 2.58/device2020-09: 0 reports for this device; peer average 1.5/device2020-10: 0 reports for this device; peer average 1.4/device2020-11: 0 reports for this device; peer average 3.13/device2020-12: 0 reports for this device; peer average 1.67/device2021-01: 0 reports for this device; peer average 1.8/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1.4/device2021-04: 0 reports for this device; peer average 1.15/device2021-05: 0 reports for this device; peer average 1.58/device2021-06: 0 reports for this device; peer average 2.4/device2021-07: 0 reports for this device; peer average 1.17/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1.57/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 1.71/device2021-12: 0 reports for this device; peer average 1.21/device2022-01: 0 reports for this device; peer average 1.67/device2022-02: 0 reports for this device; peer average 2.25/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 2.8/device2022-07: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 3/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 2.5/device2022-11: 0 reports for this device; peer average 1.5/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 4.5/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 1.33/device2023-05: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 2/device2023-08: 0 reports for this device; peer average 1.33/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 2.71/device2024-01: 0 reports for this device; peer average 1.75/device2024-02: 0 reports for this device; peer average 1.33/device2024-03: 0 reports for this device; peer average 1.4/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1.4/device2024-06: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1.67/device2025-02: 0 reports for this device; peer average 1.5/device2025-03: 0 reports for this device; peer average 1.33/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 1.75/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1.33/device2025-08: 0 reports for this device; peer average 1.25/device2025-09: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1.33/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.25/device2026-03: 0 reports for this device; peer average 1.5/device2026-04: 0 reports for this device; peer average 1.67/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 2/device0102030405060708091011120102030405060708091011120102030405060708091011120102030405060708091011120102030506070810110102030405060809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.64
2019-0201.33
2019-0301.5
2019-0401.5
2019-0501.75
2019-0601.8
2019-0701.57
2019-0801.33
2019-0901.5
2019-1001.5
2019-1101
2019-1202
2020-0101.17
2020-0201.43
2020-0302.2
2020-0401
2020-0501
2020-0602.14
2020-0703.2
2020-0802.58
2020-0901.5
2020-1001.4
2020-1103.13
2020-1201.67
2021-0101.8
2021-0201
2021-0301.4
2021-0401.15
2021-0501.58
2021-0602.4
2021-0701.17
2021-0802
2021-0901.57
2021-1002
2021-1101.71
2021-1201.21
2022-0101.67
2022-0202.25
2022-0301
2022-0401
2022-0501
2022-0602.8
2022-0701
2022-0803
2022-0901
2022-1002.5
2022-1101.5
2022-1201
2023-0104.5
2023-0203
2023-0301.33
2023-0503
2023-0601
2023-0702
2023-0801.33
2023-1002
2023-1102.71
2024-0101.75
2024-0201.33
2024-0301.4
2024-0402
2024-0501.4
2024-0601
2024-0801
2024-0901
2024-1002
2024-1102
2024-1201
2025-0101.67
2025-0201.5
2025-0301.33
2025-0401.5
2025-0501.75
2025-0601
2025-0701.33
2025-0801.25
2025-0901.5
2025-1002
2025-1101.33
2025-1202
2026-0101
2026-0201.25
2026-0301.5
2026-0401.67
2026-0501.5
2026-0602
This device (reports/month)Average device in NPJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K133256 — cites (transitively): K093513 (d1), K131467 (d1), K122870 (d2), K080528 (d3), K091956 (d3), K094050 (d3), K103117 (d3), K103223 (d3), K112780 (d3), K113378 (d3), K113756 (d3), K120068 (d3), K120316 (d3), K020114 (d4), K032905 (d4), K040267 (d4), K042515 (d4), K052687 (d4), K100900 (d4), K905613 (d4), K932246 (d4), K030686 (d5), K923277 (d5), K932425 (d5), K932690 (d5), K932776 (d5), K933494 (d5), K933539 (d5) — cited as predicate by K161366, K193105

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

Manufacturer compliance record — Conformis, Inc.

  • Warning Letter 2019-12-10 Conformis Inc.
  • VAI 2026-01-13 Conformis Inc. · 1 citations
  • VAI 2023-03-09 Conformis, Inc. · 4 citations
  • NAI 2021-07-08 Conformis Inc. · 0 citations
  • VAI 2019-09-20 Conformis, Inc. · 2 citations
  • OAI 2019-09-20 Conformis Inc. · 4 citations
  • VAI 2018-09-07 Conformis, Inc. · 6 citations
  • VAI 2015-09-14 Conformis Inc. · 3 citations
  • NAI 2015-06-12 Conformis, Inc. · 0 citations
  • NAI 2013-03-18 Conformis, Inc. · 0 citations