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Dynasty

Model DLDMGH48 · Microport Orthopedics Inc. · DI 00192629259935

KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented · Class II · 21 CFR 888.3390

LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · 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 2026-09-12 · 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.

11232019-01: 0 reports for this device; peer average 2.4/device2019-02: 0 reports for this device; peer average 2.2/device2019-03: 0 reports for this device; peer average 2.48/device2019-04: 0 reports for this device; peer average 2.42/device2019-05: 0 reports for this device; peer average 1.94/device2019-06: 0 reports for this device; peer average 1.71/device2019-07: 0 reports for this device; peer average 1.65/device2019-08: 0 reports for this device; peer average 1.97/device2019-09: 0 reports for this device; peer average 1.98/device2019-10: 0 reports for this device; peer average 2.21/device2019-11: 0 reports for this device; peer average 1.95/device2019-12: 0 reports for this device; peer average 2.23/device2020-01: 0 reports for this device; peer average 2.61/device2020-02: 0 reports for this device; peer average 2.17/device2020-03: 0 reports for this device; peer average 2.66/device2020-04: 0 reports for this device; peer average 2.04/device2020-05: 0 reports for this device; peer average 1.98/device2020-06: 0 reports for this device; peer average 1.86/device2020-07: 0 reports for this device; peer average 2.24/device2020-08: 0 reports for this device; peer average 1.91/device2020-09: 0 reports for this device; peer average 2.4/device2020-10: 0 reports for this device; peer average 2.29/device2020-11: 0 reports for this device; peer average 2.08/device2020-12: 0 reports for this device; peer average 2.19/device2021-01: 0 reports for this device; peer average 2.25/device2021-02: 0 reports for this device; peer average 1.93/device2021-03: 0 reports for this device; peer average 1.93/device2021-04: 0 reports for this device; peer average 1.89/device2021-05: 0 reports for this device; peer average 1.9/device2021-06: 0 reports for this device; peer average 2.17/device2021-07: 0 reports for this device; peer average 2.21/device2021-08: 0 reports for this device; peer average 2.18/device2021-09: 0 reports for this device; peer average 2.34/device2021-10: 0 reports for this device; peer average 2.12/device2021-11: 0 reports for this device; peer average 1.94/device2021-12: 0 reports for this device; peer average 2.13/device2022-01: 0 reports for this device; peer average 1.98/device2022-02: 0 reports for this device; peer average 1.96/device2022-03: 0 reports for this device; peer average 2.01/device2022-04: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 2.12/device2022-06: 0 reports for this device; peer average 2.05/device2022-07: 0 reports for this device; peer average 1.99/device2022-08: 0 reports for this device; peer average 2.02/device2022-09: 0 reports for this device; peer average 2.11/device2022-10: 0 reports for this device; peer average 2.02/device2022-11: 0 reports for this device; peer average 2.09/device2022-12: 0 reports for this device; peer average 2.07/device2023-01: 0 reports for this device; peer average 2.33/device2023-02: 0 reports for this device; peer average 1.99/device2023-03: 0 reports for this device; peer average 2.1/device2023-04: 0 reports for this device; peer average 2.12/device2023-05: 0 reports for this device; peer average 2.02/device2023-06: 0 reports for this device; peer average 2.05/device2023-07: 0 reports for this device; peer average 1.96/device2023-08: 0 reports for this device; peer average 1.77/device2023-09: 0 reports for this device; peer average 1.79/device2023-10: 0 reports for this device; peer average 1.58/device2023-11: 0 reports for this device; peer average 1.55/device2023-12: 0 reports for this device; peer average 1.67/device2024-01: 0 reports for this device; peer average 1.69/device2024-02: 0 reports for this device; peer average 1.9/device2024-03: 0 reports for this device; peer average 1.82/device2024-04: 0 reports for this device; peer average 1.68/device2024-05: 0 reports for this device; peer average 1.89/device2024-06: 0 reports for this device; peer average 1.75/device2024-07: 0 reports for this device; peer average 1.62/device2024-08: 0 reports for this device; peer average 1.77/device2024-09: 0 reports for this device; peer average 1.79/device2024-10: 0 reports for this device; peer average 1.68/device2024-11: 0 reports for this device; peer average 1.74/device2024-12: 0 reports for this device; peer average 1.54/device2025-01: 0 reports for this device; peer average 1.91/device2025-02: 0 reports for this device; peer average 1.5/device2025-03: 0 reports for this device; peer average 1.79/device2025-04: 0 reports for this device; peer average 1.8/device2025-05: 0 reports for this device; peer average 1.7/device2025-06: 0 reports for this device; peer average 1.81/device2025-07: 0 reports for this device; peer average 1.78/device2025-08: 0 reports for this device; peer average 1.7/device2025-09: 0 reports for this device; peer average 1.63/device2025-10: 0 reports for this device; peer average 1.72/device2025-11: 0 reports for this device; peer average 1.76/device2025-12: 0 reports for this device; peer average 1.86/device2026-01: 0 reports for this device; peer average 1.88/device2026-02: 0 reports for this device; peer average 1.61/device2026-03: 0 reports for this device; peer average 1.83/device2026-04: 0 reports for this device; peer average 1.93/device2026-05: 0 reports for this device; peer average 1.66/device2026-06: 0 reports for this device; peer average 1.66/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.4
2019-0202.2
2019-0302.48
2019-0402.42
2019-0501.94
2019-0601.71
2019-0701.65
2019-0801.97
2019-0901.98
2019-1002.21
2019-1101.95
2019-1202.23
2020-0102.61
2020-0202.17
2020-0302.66
2020-0402.04
2020-0501.98
2020-0601.86
2020-0702.24
2020-0801.91
2020-0902.4
2020-1002.29
2020-1102.08
2020-1202.19
2021-0102.25
2021-0201.93
2021-0301.93
2021-0401.89
2021-0501.9
2021-0602.17
2021-0702.21
2021-0802.18
2021-0902.34
2021-1002.12
2021-1101.94
2021-1202.13
2022-0101.98
2022-0201.96
2022-0302.01
2022-0402
2022-0502.12
2022-0602.05
2022-0701.99
2022-0802.02
2022-0902.11
2022-1002.02
2022-1102.09
2022-1202.07
2023-0102.33
2023-0201.99
2023-0302.1
2023-0402.12
2023-0502.02
2023-0602.05
2023-0701.96
2023-0801.77
2023-0901.79
2023-1001.58
2023-1101.55
2023-1201.67
2024-0101.69
2024-0201.9
2024-0301.82
2024-0401.68
2024-0501.89
2024-0601.75
2024-0701.62
2024-0801.77
2024-0901.79
2024-1001.68
2024-1101.74
2024-1201.54
2025-0101.91
2025-0201.5
2025-0301.79
2025-0401.8
2025-0501.7
2025-0601.81
2025-0701.78
2025-0801.7
2025-0901.63
2025-1001.72
2025-1101.76
2025-1201.86
2026-0101.88
2026-0201.61
2026-0301.83
2026-0401.93
2026-0501.66
2026-0601.66
This device (reports/month)Average device in KWY, LZO, OQG (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K200011 — cites (transitively): K061844 (d1), K083116 (d1), K150522 (d1), K161190 (d1), K171181 (d1), K892398 (d1), K030555 (d2), K101336 (d2), K103233 (d2), K110555 (d2), K121874 (d2), K140669 (d2), K974558 (d2), K991990 (d2), K002149 (d2), K004043 (d2), K021349 (d2), K051348 (d2), K052026 (d2), K061547 (d2), K070785 (d2), K072656 (d2), K082924 (d2), K094035 (d2), K130376 (d2), K140043 (d2), K142119 (d2), K170444 (d2), K893685 (d2), K920593 (d2), K925512 (d2), K932222 (d2), P030027 (d2), K032396 (d3), K050327 (d3), K051588 (d3), K071535 (d3), K073102 (d3), K083762 (d3), K935484 (d3), K950827 (d3), K970501 (d3), K042037 (d3), K062995 (d3), K070364 (d3), K070399 (d3), K072020 (d3), K093644 (d3), K100048 (d3), K042051 (d3), K093235 (d3), K003016 (d3), K021346 (d3), K041586 (d3), K052915 (d3), K053588 (d3), K091423 (d3), K100866 (d3), K111698 (d3), K111699 (d3), K111910 (d3), K121221 (d3), K122382 (d3), K123434 (d3), K123688 (d3), K012091 (d3), K014236 (d3), K060358 (d3), K080663 (d3), K052996 (d3), K102975 (d3), K122770 (d3), K122798 (d3), K041114 (d3), K864626 (d3), K002379 (d4), K070369 (d4), K080528 (d4), K090103 (d4), K070479 (d4), K051995 (d4), K081090 (d4), K112080 (d4), K121544 (d4), K070592 (d4), K123686 (d4) — cited as predicate by K240046

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

Manufacturer compliance record — Microport Orthopedics Inc.

  • Warning Letter 2015-06-17 MicroPort Orthopedics Inc.
  • Warning Letter 2015-06-17 MicroPort Orthopedics Inc.
  • NAI 2023-02-08 MicroPort Orthopedics Inc. · 0 citations
  • NAI 2023-02-08 MicroPort Orthopedics Inc. · 0 citations
  • VAI 2018-06-29 MicroPort Orthopedics Inc. · 2 citations
  • VAI 2018-06-29 MicroPort Orthopedics Inc. · 2 citations
  • VAI 2015-08-19 MicroPort Orthopedics Inc. · 5 citations
  • VAI 2015-08-19 MicroPort Orthopedics Inc. · 5 citations