Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Ceramic Femoral Head

Model 1203-5222 · UNITED ORTHOPEDIC CORP. · DI 04719886890839

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

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

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.

12332019-01: 0 reports for this device; peer average 3.28/device2019-02: 0 reports for this device; peer average 2.81/device2019-03: 0 reports for this device; peer average 3.24/device2019-04: 0 reports for this device; peer average 3.02/device2019-05: 0 reports for this device; peer average 2.32/device2019-06: 0 reports for this device; peer average 1.95/device2019-07: 0 reports for this device; peer average 1.97/device2019-08: 0 reports for this device; peer average 2.25/device2019-09: 0 reports for this device; peer average 2.66/device2019-10: 0 reports for this device; peer average 2.91/device2019-11: 0 reports for this device; peer average 2.35/device2019-12: 0 reports for this device; peer average 2.67/device2020-01: 0 reports for this device; peer average 3.06/device2020-02: 0 reports for this device; peer average 2.67/device2020-03: 0 reports for this device; peer average 3.4/device2020-04: 0 reports for this device; peer average 2.41/device2020-05: 0 reports for this device; peer average 2.28/device2020-06: 0 reports for this device; peer average 2.25/device2020-07: 0 reports for this device; peer average 2.62/device2020-08: 0 reports for this device; peer average 2.1/device2020-09: 0 reports for this device; peer average 2.68/device2020-10: 0 reports for this device; peer average 2.59/device2020-11: 0 reports for this device; peer average 2.48/device2020-12: 0 reports for this device; peer average 2.46/device2021-01: 0 reports for this device; peer average 2.7/device2021-02: 0 reports for this device; peer average 2.12/device2021-03: 0 reports for this device; peer average 2.11/device2021-04: 0 reports for this device; peer average 2.19/device2021-05: 0 reports for this device; peer average 1.99/device2021-06: 0 reports for this device; peer average 2.69/device2021-07: 0 reports for this device; peer average 2.37/device2021-08: 0 reports for this device; peer average 2.47/device2021-09: 0 reports for this device; peer average 2.43/device2021-10: 0 reports for this device; peer average 2.24/device2021-11: 0 reports for this device; peer average 2.14/device2021-12: 0 reports for this device; peer average 2.43/device2022-01: 0 reports for this device; peer average 2.16/device2022-02: 0 reports for this device; peer average 1.94/device2022-03: 0 reports for this device; peer average 2.32/device2022-04: 0 reports for this device; peer average 2.22/device2022-05: 0 reports for this device; peer average 2.13/device2022-06: 0 reports for this device; peer average 2.43/device2022-07: 0 reports for this device; peer average 2.11/device2022-08: 0 reports for this device; peer average 2.24/device2022-09: 0 reports for this device; peer average 2.24/device2022-10: 0 reports for this device; peer average 2.18/device2022-11: 0 reports for this device; peer average 2.24/device2022-12: 0 reports for this device; peer average 2.27/device2023-01: 0 reports for this device; peer average 2.49/device2023-02: 0 reports for this device; peer average 2.28/device2023-03: 0 reports for this device; peer average 2.57/device2023-04: 0 reports for this device; peer average 2.38/device2023-05: 0 reports for this device; peer average 2.26/device2023-06: 0 reports for this device; peer average 2.3/device2023-07: 0 reports for this device; peer average 2.08/device2023-08: 0 reports for this device; peer average 1.96/device2023-09: 0 reports for this device; peer average 1.96/device2023-10: 0 reports for this device; peer average 1.73/device2023-11: 0 reports for this device; peer average 1.63/device2023-12: 0 reports for this device; peer average 1.75/device2024-01: 0 reports for this device; peer average 1.78/device2024-02: 0 reports for this device; peer average 2.13/device2024-03: 0 reports for this device; peer average 1.95/device2024-04: 0 reports for this device; peer average 1.74/device2024-05: 0 reports for this device; peer average 1.92/device2024-06: 0 reports for this device; peer average 1.86/device2024-07: 0 reports for this device; peer average 1.73/device2024-08: 0 reports for this device; peer average 1.8/device2024-09: 0 reports for this device; peer average 2.07/device2024-10: 0 reports for this device; peer average 1.86/device2024-11: 0 reports for this device; peer average 1.79/device2024-12: 0 reports for this device; peer average 1.56/device2025-01: 0 reports for this device; peer average 1.97/device2025-02: 0 reports for this device; peer average 1.53/device2025-03: 0 reports for this device; peer average 1.86/device2025-04: 0 reports for this device; peer average 1.82/device2025-05: 0 reports for this device; peer average 1.74/device2025-06: 0 reports for this device; peer average 1.85/device2025-07: 0 reports for this device; peer average 1.9/device2025-08: 0 reports for this device; peer average 1.71/device2025-09: 0 reports for this device; peer average 1.75/device2025-10: 0 reports for this device; peer average 1.73/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 1.97/device2026-02: 0 reports for this device; peer average 1.6/device2026-03: 0 reports for this device; peer average 1.88/device2026-04: 0 reports for this device; peer average 1.84/device2026-05: 0 reports for this device; peer average 1.57/device2026-06: 0 reports for this device; peer average 1.71/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103.28
2019-0202.81
2019-0303.24
2019-0403.02
2019-0502.32
2019-0601.95
2019-0701.97
2019-0802.25
2019-0902.66
2019-1002.91
2019-1102.35
2019-1202.67
2020-0103.06
2020-0202.67
2020-0303.4
2020-0402.41
2020-0502.28
2020-0602.25
2020-0702.62
2020-0802.1
2020-0902.68
2020-1002.59
2020-1102.48
2020-1202.46
2021-0102.7
2021-0202.12
2021-0302.11
2021-0402.19
2021-0501.99
2021-0602.69
2021-0702.37
2021-0802.47
2021-0902.43
2021-1002.24
2021-1102.14
2021-1202.43
2022-0102.16
2022-0201.94
2022-0302.32
2022-0402.22
2022-0502.13
2022-0602.43
2022-0702.11
2022-0802.24
2022-0902.24
2022-1002.18
2022-1102.24
2022-1202.27
2023-0102.49
2023-0202.28
2023-0302.57
2023-0402.38
2023-0502.26
2023-0602.3
2023-0702.08
2023-0801.96
2023-0901.96
2023-1001.73
2023-1101.63
2023-1201.75
2024-0101.78
2024-0202.13
2024-0301.95
2024-0401.74
2024-0501.92
2024-0601.86
2024-0701.73
2024-0801.8
2024-0902.07
2024-1001.86
2024-1101.79
2024-1201.56
2025-0101.97
2025-0201.53
2025-0301.86
2025-0401.82
2025-0501.74
2025-0601.85
2025-0701.9
2025-0801.71
2025-0901.75
2025-1001.73
2025-1101.76
2025-1201.86
2026-0101.97
2026-0201.6
2026-0301.88
2026-0401.84
2026-0501.57
2026-0601.71
This device (reports/month)Average device in KWY, LPH (reports/device/month)

Regulatory clearances

  • K221675 SESE 2022-11-04 (k number procode)

Predicate lineage

K221675 — cites (transitively): K003237 (d1), K062978 (d1), K103497 (d1), K110245 (d1), K111546 (d1), K112463 (d1), K122185 (d1), K123550 (d1), K132207 (d1), K151316 (d1), K152439 (d1), K162957 (d1), K163193 (d1), K172251 (d1), K180929 (d1), K183312 (d1), K022520 (d2), K043537 (d2), K050262 (d2), K050269 (d2), K052792 (d2), K101670 (d2), K103479 (d2), K921301 (d2), K994078 (d2), K001733 (d2), K061066 (d2), K070756 (d2), K990369 (d2), K993352 (d2), K042091 (d2), K061312 (d2), K083762 (d2), K100412 (d2), K061253 (d2), K092386 (d2), K093472 (d2), K093846 (d2), K101229 (d2), K103662 (d2), K121777 (d2), K122504 (d2), K132455 (d2), K013211 (d2), K060707 (d2), K800207 (d2), K964769 (d2), K152530 (d2), K073570 (d2), K100445 (d2), K141972 (d2), K143407 (d2), K161073 (d2), K173104 (d2), K042992 (d2), K091508 (d3), K071535 (d3), K082844 (d3), K030373 (d3), K062489 (d3), K073068 (d3), K063257 (d3), K030265 (d3), K082239 (d3), K052026 (d3), K103384 (d3), K000306 (d4), K042565 (d4), K062148 (d4) — cited as predicate by K242249, K242315, K243466

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