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ACTERA

Model HES-034-0011-01 · Conformis, Inc. · DI M572HES0340011011

MEH — Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate · Class II · 21 CFR 888.3353

OQG — Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented · Class II · 21 CFR 888.3358

UDILibrary device dossier · generated 2026-09-16 · 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.

01122019-01: 0 reports for this device; peer average 1.76/device2019-02: 0 reports for this device; peer average 1.62/device2019-03: 0 reports for this device; peer average 1.71/device2019-04: 0 reports for this device; peer average 1.91/device2019-05: 0 reports for this device; peer average 1.63/device2019-06: 0 reports for this device; peer average 1.35/device2019-07: 0 reports for this device; peer average 1.44/device2019-08: 0 reports for this device; peer average 1.59/device2019-09: 0 reports for this device; peer average 1.53/device2019-10: 0 reports for this device; peer average 1.57/device2019-11: 0 reports for this device; peer average 1.68/device2019-12: 0 reports for this device; peer average 1.57/device2020-01: 0 reports for this device; peer average 1.54/device2020-02: 0 reports for this device; peer average 1.56/device2020-03: 0 reports for this device; peer average 1.85/device2020-04: 0 reports for this device; peer average 1.48/device2020-05: 0 reports for this device; peer average 1.34/device2020-06: 0 reports for this device; peer average 1.41/device2020-07: 0 reports for this device; peer average 1.63/device2020-08: 0 reports for this device; peer average 1.48/device2020-09: 0 reports for this device; peer average 1.67/device2020-10: 0 reports for this device; peer average 1.55/device2020-11: 0 reports for this device; peer average 1.49/device2020-12: 0 reports for this device; peer average 1.58/device2021-01: 0 reports for this device; peer average 1.54/device2021-02: 0 reports for this device; peer average 1.42/device2021-03: 0 reports for this device; peer average 1.46/device2021-04: 0 reports for this device; peer average 1.52/device2021-05: 0 reports for this device; peer average 1.54/device2021-06: 0 reports for this device; peer average 1.58/device2021-07: 0 reports for this device; peer average 1.47/device2021-08: 0 reports for this device; peer average 1.39/device2021-09: 0 reports for this device; peer average 1.8/device2021-10: 0 reports for this device; peer average 1.55/device2021-11: 0 reports for this device; peer average 1.51/device2021-12: 0 reports for this device; peer average 1.5/device2022-01: 0 reports for this device; peer average 1.42/device2022-02: 0 reports for this device; peer average 1.45/device2022-03: 0 reports for this device; peer average 1.42/device2022-04: 0 reports for this device; peer average 1.44/device2022-05: 0 reports for this device; peer average 1.6/device2022-06: 0 reports for this device; peer average 1.55/device2022-07: 0 reports for this device; peer average 1.47/device2022-08: 0 reports for this device; peer average 1.6/device2022-09: 0 reports for this device; peer average 1.64/device2022-10: 0 reports for this device; peer average 1.52/device2022-11: 0 reports for this device; peer average 1.63/device2022-12: 0 reports for this device; peer average 1.4/device2023-01: 0 reports for this device; peer average 1.32/device2023-02: 0 reports for this device; peer average 1.41/device2023-03: 0 reports for this device; peer average 1.58/device2023-04: 0 reports for this device; peer average 1.72/device2023-05: 0 reports for this device; peer average 1.64/device2023-06: 0 reports for this device; peer average 1.76/device2023-07: 0 reports for this device; peer average 1.75/device2023-08: 0 reports for this device; peer average 1.6/device2023-09: 0 reports for this device; peer average 1.65/device2023-10: 0 reports for this device; peer average 1.35/device2023-11: 0 reports for this device; peer average 1.31/device2023-12: 0 reports for this device; peer average 1.4/device2024-01: 0 reports for this device; peer average 1.5/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 1.75/device2024-04: 0 reports for this device; peer average 1.56/device2024-05: 0 reports for this device; peer average 1.93/device2024-06: 0 reports for this device; peer average 1.74/device2024-07: 0 reports for this device; peer average 1.46/device2024-08: 0 reports for this device; peer average 1.79/device2024-09: 0 reports for this device; peer average 1.66/device2024-10: 0 reports for this device; peer average 1.54/device2024-11: 0 reports for this device; peer average 1.39/device2024-12: 0 reports for this device; peer average 1.37/device2025-01: 0 reports for this device; peer average 1.58/device2025-02: 0 reports for this device; peer average 1.37/device2025-03: 0 reports for this device; peer average 1.68/device2025-04: 0 reports for this device; peer average 1.62/device2025-05: 0 reports for this device; peer average 1.4/device2025-06: 0 reports for this device; peer average 1.64/device2025-07: 0 reports for this device; peer average 1.55/device2025-08: 0 reports for this device; peer average 1.42/device2025-09: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 1.49/device2025-11: 0 reports for this device; peer average 1.61/device2025-12: 0 reports for this device; peer average 1.81/device2026-01: 0 reports for this device; peer average 1.61/device2026-02: 0 reports for this device; peer average 1.4/device2026-03: 0 reports for this device; peer average 1.82/device2026-04: 0 reports for this device; peer average 1.74/device2026-05: 0 reports for this device; peer average 1.42/device2026-06: 0 reports for this device; peer average 1.52/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.76
2019-0201.62
2019-0301.71
2019-0401.91
2019-0501.63
2019-0601.35
2019-0701.44
2019-0801.59
2019-0901.53
2019-1001.57
2019-1101.68
2019-1201.57
2020-0101.54
2020-0201.56
2020-0301.85
2020-0401.48
2020-0501.34
2020-0601.41
2020-0701.63
2020-0801.48
2020-0901.67
2020-1001.55
2020-1101.49
2020-1201.58
2021-0101.54
2021-0201.42
2021-0301.46
2021-0401.52
2021-0501.54
2021-0601.58
2021-0701.47
2021-0801.39
2021-0901.8
2021-1001.55
2021-1101.51
2021-1201.5
2022-0101.42
2022-0201.45
2022-0301.42
2022-0401.44
2022-0501.6
2022-0601.55
2022-0701.47
2022-0801.6
2022-0901.64
2022-1001.52
2022-1101.63
2022-1201.4
2023-0101.32
2023-0201.41
2023-0301.58
2023-0401.72
2023-0501.64
2023-0601.76
2023-0701.75
2023-0801.6
2023-0901.65
2023-1001.35
2023-1101.31
2023-1201.4
2024-0101.5
2024-0201.5
2024-0301.75
2024-0401.56
2024-0501.93
2024-0601.74
2024-0701.46
2024-0801.79
2024-0901.66
2024-1001.54
2024-1101.39
2024-1201.37
2025-0101.58
2025-0201.37
2025-0301.68
2025-0401.62
2025-0501.4
2025-0601.64
2025-0701.55
2025-0801.42
2025-0901.5
2025-1001.49
2025-1101.61
2025-1201.81
2026-0101.61
2026-0201.4
2026-0301.82
2026-0401.74
2026-0501.42
2026-0601.52
This device (reports/month)Average device in MEH, OQG (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K231178 — cites (transitively): K192198 (d1), K202484 (d1), K221104 (d1), K162719 (d2), K190904 (d2), K210581 (d2), K042992 (d3), K111863 (d3), K112802 (d3), K160025 (d3), K161668 (d3), K102795 (d3), K160907 (d3), K170339 (d3), K202472 (d3), K073449 (d4), K093533 (d4), K030047 (d4), K030055 (d4), K031454 (d4), K042989 (d4), K050124 (d4), K052996 (d4), K070369 (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), K010170 (d4), K041906 (d4), K042842 (d4), K052792 (d4), K094035 (d4), K102487 (d4), K142161 (d4), K142404 (d4), K152704 (d4), K150862 (d4), K153217 (d4), K001991 (d4), K011489 (d4), K013352 (d4), K023453 (d4), K030122 (d4), K123991 (d4), K193398 (d4), K082358 (d5), K032396 (d5), K050327 (d5), K051588 (d5), K071535 (d5), K073102 (d5), K083762 (d5), K935484 (d5), K950827 (d5), K042037 (d5), K042051 (d5), K062995 (d5), K101336 (d5), K070554 (d5), K812672 (d5), K903084 (d5), K140423 (d5), K140833 (d5), K140257 (d5), K143226 (d5), K001911 (d5), K192919 (d5), K070364 (d6), K070399 (d6), K072020 (d6), K083116 (d6), K093644 (d6), K100048 (d6), K110415 (d6), P010014 (d6), K120068 (d6), K122033 (d6), K122991 (d6), K131019 (d6), K131467 (d6), K111433 (d6), K113369 (d6), K032295 (d6), K041825 (d6), K093746 (d6), K121393 (d6), K123159 (d6), K141585 (d6), K951987 (d6), K000306 (d6), K031495 (d6), K192191 (d6), K071071 (d7), K962557 (d7), K080528 (d7), K090103 (d7), K101433 (d7), K060370 (d7), K073286 (d7), K933785 (d7), K936159 (d7), K960279 (d7), K094050 (d7), K112780 (d7), K032683 (d7), K041106 (d7), K042515 (d7), K051229 (d7), K072531 (d7), K100897 (d7), K953274 (d7), K954909 (d7), K962137 (d7), K103117 (d7), K113378 (d7), K120316 (d7), K120058 (d7), K122870 (d7), K040267 (d8), K052687 (d8), K030623 (d8), K040166 (d8), K082500 (d8), K943462 (d8), K961685 (d8), K101681 (d8), K091956 (d8), K103223 (d8), K113756 (d8) — cited as predicate by K252067

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