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"""UNITED"" USTAR II Hip System"

Model 1115-3217 · UNITED ORTHOPEDIC CORP. · DI 04719872153962

KRO — Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer · Class II · 21 CFR 888.3510

KWL — Prosthesis, Hip, Hemi-, Femoral, Metal · Class II · 21 CFR 888.3360

LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented · Class II · 21 CFR 888.3358

LWJ — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented · Class II · 21 CFR 888.3360

UDILibrary device dossier · generated 2026-09-08 · 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.

12232019-01: 0 reports for this device; peer average 3.07/device2019-02: 0 reports for this device; peer average 2.7/device2019-03: 0 reports for this device; peer average 3.01/device2019-04: 0 reports for this device; peer average 2.78/device2019-05: 0 reports for this device; peer average 2.19/device2019-06: 0 reports for this device; peer average 1.85/device2019-07: 0 reports for this device; peer average 1.92/device2019-08: 0 reports for this device; peer average 2.22/device2019-09: 0 reports for this device; peer average 2.45/device2019-10: 0 reports for this device; peer average 2.69/device2019-11: 0 reports for this device; peer average 2.22/device2019-12: 0 reports for this device; peer average 2.53/device2020-01: 0 reports for this device; peer average 2.77/device2020-02: 0 reports for this device; peer average 2.58/device2020-03: 0 reports for this device; peer average 3.25/device2020-04: 0 reports for this device; peer average 2.34/device2020-05: 0 reports for this device; peer average 2.36/device2020-06: 0 reports for this device; peer average 2.13/device2020-07: 0 reports for this device; peer average 2.54/device2020-08: 0 reports for this device; peer average 1.98/device2020-09: 0 reports for this device; peer average 2.5/device2020-10: 0 reports for this device; peer average 2.52/device2020-11: 0 reports for this device; peer average 2.35/device2020-12: 0 reports for this device; peer average 2.32/device2021-01: 0 reports for this device; peer average 2.41/device2021-02: 0 reports for this device; peer average 2.02/device2021-03: 0 reports for this device; peer average 2.08/device2021-04: 0 reports for this device; peer average 2.14/device2021-05: 0 reports for this device; peer average 1.99/device2021-06: 0 reports for this device; peer average 2.62/device2021-07: 0 reports for this device; peer average 2.44/device2021-08: 0 reports for this device; peer average 2.41/device2021-09: 0 reports for this device; peer average 2.44/device2021-10: 0 reports for this device; peer average 2.2/device2021-11: 0 reports for this device; peer average 2.22/device2021-12: 0 reports for this device; peer average 2.45/device2022-01: 0 reports for this device; peer average 2.15/device2022-02: 0 reports for this device; peer average 2.24/device2022-03: 0 reports for this device; peer average 2.2/device2022-04: 0 reports for this device; peer average 2.25/device2022-05: 0 reports for this device; peer average 2.11/device2022-06: 0 reports for this device; peer average 2.35/device2022-07: 0 reports for this device; peer average 2.14/device2022-08: 0 reports for this device; peer average 2.24/device2022-09: 0 reports for this device; peer average 2.19/device2022-10: 0 reports for this device; peer average 2.19/device2022-11: 0 reports for this device; peer average 2.32/device2022-12: 0 reports for this device; peer average 2.25/device2023-01: 0 reports for this device; peer average 2.32/device2023-02: 0 reports for this device; peer average 2.21/device2023-03: 0 reports for this device; peer average 2.51/device2023-04: 0 reports for this device; peer average 2.35/device2023-05: 0 reports for this device; peer average 2.32/device2023-06: 0 reports for this device; peer average 2.37/device2023-07: 0 reports for this device; peer average 2.18/device2023-08: 0 reports for this device; peer average 2.2/device2023-09: 0 reports for this device; peer average 2.16/device2023-10: 0 reports for this device; peer average 1.72/device2023-11: 0 reports for this device; peer average 1.68/device2023-12: 0 reports for this device; peer average 1.78/device2024-01: 0 reports for this device; peer average 1.84/device2024-02: 0 reports for this device; peer average 2.09/device2024-03: 0 reports for this device; peer average 2.06/device2024-04: 0 reports for this device; peer average 1.83/device2024-05: 0 reports for this device; peer average 2.19/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1.83/device2024-08: 0 reports for this device; peer average 1.96/device2024-09: 0 reports for this device; peer average 2.29/device2024-10: 0 reports for this device; peer average 1.95/device2024-11: 0 reports for this device; peer average 1.79/device2024-12: 0 reports for this device; peer average 1.61/device2025-01: 0 reports for this device; peer average 1.9/device2025-02: 0 reports for this device; peer average 1.57/device2025-03: 0 reports for this device; peer average 1.81/device2025-04: 0 reports for this device; peer average 1.85/device2025-05: 0 reports for this device; peer average 1.75/device2025-06: 0 reports for this device; peer average 1.85/device2025-07: 0 reports for this device; peer average 1.91/device2025-08: 0 reports for this device; peer average 1.77/device2025-09: 0 reports for this device; peer average 1.87/device2025-10: 0 reports for this device; peer average 1.76/device2025-11: 0 reports for this device; peer average 1.86/device2025-12: 0 reports for this device; peer average 1.89/device2026-01: 0 reports for this device; peer average 2.08/device2026-02: 0 reports for this device; peer average 1.7/device2026-03: 0 reports for this device; peer average 2.03/device2026-04: 0 reports for this device; peer average 1.79/device2026-05: 0 reports for this device; peer average 1.74/device2026-06: 0 reports for this device; peer average 1.76/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.07
2019-0202.7
2019-0303.01
2019-0402.78
2019-0502.19
2019-0601.85
2019-0701.92
2019-0802.22
2019-0902.45
2019-1002.69
2019-1102.22
2019-1202.53
2020-0102.77
2020-0202.58
2020-0303.25
2020-0402.34
2020-0502.36
2020-0602.13
2020-0702.54
2020-0801.98
2020-0902.5
2020-1002.52
2020-1102.35
2020-1202.32
2021-0102.41
2021-0202.02
2021-0302.08
2021-0402.14
2021-0501.99
2021-0602.62
2021-0702.44
2021-0802.41
2021-0902.44
2021-1002.2
2021-1102.22
2021-1202.45
2022-0102.15
2022-0202.24
2022-0302.2
2022-0402.25
2022-0502.11
2022-0602.35
2022-0702.14
2022-0802.24
2022-0902.19
2022-1002.19
2022-1102.32
2022-1202.25
2023-0102.32
2023-0202.21
2023-0302.51
2023-0402.35
2023-0502.32
2023-0602.37
2023-0702.18
2023-0802.2
2023-0902.16
2023-1001.72
2023-1101.68
2023-1201.78
2024-0101.84
2024-0202.09
2024-0302.06
2024-0401.83
2024-0502.19
2024-0602
2024-0701.83
2024-0801.96
2024-0902.29
2024-1001.95
2024-1101.79
2024-1201.61
2025-0101.9
2025-0201.57
2025-0301.81
2025-0401.85
2025-0501.75
2025-0601.85
2025-0701.91
2025-0801.77
2025-0901.87
2025-1001.76
2025-1101.86
2025-1201.89
2026-0102.08
2026-0201.7
2026-0302.03
2026-0401.79
2026-0501.74
2026-0601.76
This device (reports/month)Average device in KRO, KWL, LPH, LWJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K190100 — cites (transitively): K002757 (d1), K013385 (d1), K023087 (d1), K052685 (d1), K070978 (d1), K082424 (d1), K100048 (d1), K100981 (d1), K110940 (d1), K111546 (d1), K122183 (d1), K123550 (d1), K130063 (d1), K152530 (d1), K070364 (d2), K070399 (d2), K073102 (d2), K080528 (d2), K090103 (d2), K043440 (d2), K864671 (d2), K001733 (d2), K022520 (d2), K050262 (d2), K061066 (d2), K062978 (d2), K070756 (d2), K101670 (d2), K103479 (d2), K990369 (d2), K993352 (d2), K994078 (d2), K021657 (d2), K051640 (d2), K082469 (d2), K093293 (d2), K103733 (d2), K960279 (d2), K103497 (d2), K110245 (d2), K112463 (d2), K121777 (d2), K122504 (d2), K090757 (d2), K030265 (d2), K082239 (d2), K010212 (d3), K042757 (d3), K013991 (d3), K043537 (d3), K050269 (d3), K052792 (d3), K921301 (d3), K003237 (d3), K042091 (d3), K061312 (d3), K083762 (d3), K100412 (d3), K063257 (d3), K071535 (d4), K082844 (d4) — cited as predicate by K221705, K243656, K252303

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

Manufacturer compliance record — UNITED ORTHOPEDIC CORP.

  • VAI 2026-03-12 United Orthopedic Corp. · 0 citations
  • VAI 2026-03-12 United Orthopedic Corp. · 0 citations