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OPS™ FHA

Model 1205-0001 · OPTIMIZED ORTHO PTY LTD · DI 09351327000374

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

LZO — Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented · Class II · 21 CFR 888.3353

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

PLW — Acetabular Cup Orientation System · Class II · 21 CFR 888.3350

UDILibrary device dossier · generated 2026-09-15 · 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 2.28/device2019-02: 0 reports for this device; peer average 2.1/device2019-03: 0 reports for this device; peer average 2.3/device2019-04: 0 reports for this device; peer average 2.27/device2019-05: 0 reports for this device; peer average 1.86/device2019-06: 0 reports for this device; peer average 1.64/device2019-07: 0 reports for this device; peer average 1.59/device2019-08: 0 reports for this device; peer average 1.99/device2019-09: 0 reports for this device; peer average 1.88/device2019-10: 0 reports for this device; peer average 2.13/device2019-11: 0 reports for this device; peer average 1.93/device2019-12: 0 reports for this device; peer average 2.12/device2020-01: 0 reports for this device; peer average 2.43/device2020-02: 0 reports for this device; peer average 2.18/device2020-03: 0 reports for this device; peer average 2.68/device2020-04: 0 reports for this device; peer average 2.03/device2020-05: 0 reports for this device; peer average 1.89/device2020-06: 0 reports for this device; peer average 1.83/device2020-07: 0 reports for this device; peer average 2.3/device2020-08: 0 reports for this device; peer average 1.88/device2020-09: 0 reports for this device; peer average 2.28/device2020-10: 0 reports for this device; peer average 2.25/device2020-11: 0 reports for this device; peer average 2.03/device2020-12: 0 reports for this device; peer average 2.11/device2021-01: 0 reports for this device; peer average 2.14/device2021-02: 0 reports for this device; peer average 1.88/device2021-03: 0 reports for this device; peer average 1.89/device2021-04: 0 reports for this device; peer average 1.89/device2021-05: 0 reports for this device; peer average 1.86/device2021-06: 0 reports for this device; peer average 2.19/device2021-07: 0 reports for this device; peer average 2.19/device2021-08: 0 reports for this device; peer average 2.14/device2021-09: 0 reports for this device; peer average 2.36/device2021-10: 0 reports for this device; peer average 2.12/device2021-11: 0 reports for this device; peer average 1.9/device2021-12: 0 reports for this device; peer average 2.05/device2022-01: 0 reports for this device; peer average 1.93/device2022-02: 0 reports for this device; peer average 1.98/device2022-03: 0 reports for this device; peer average 2.01/device2022-04: 0 reports for this device; peer average 1.98/device2022-05: 0 reports for this device; peer average 2.12/device2022-06: 0 reports for this device; peer average 2.02/device2022-07: 0 reports for this device; peer average 2.02/device2022-08: 0 reports for this device; peer average 2.1/device2022-09: 0 reports for this device; peer average 2.17/device2022-10: 0 reports for this device; peer average 2.08/device2022-11: 0 reports for this device; peer average 2.17/device2022-12: 0 reports for this device; peer average 1.98/device2023-01: 0 reports for this device; peer average 2.26/device2023-02: 0 reports for this device; peer average 2.03/device2023-03: 0 reports for this device; peer average 2.13/device2023-04: 0 reports for this device; peer average 2.24/device2023-05: 0 reports for this device; peer average 2.1/device2023-06: 0 reports for this device; peer average 2.26/device2023-07: 0 reports for this device; peer average 2.21/device2023-08: 0 reports for this device; peer average 1.99/device2023-09: 0 reports for this device; peer average 2.03/device2023-10: 0 reports for this device; peer average 1.68/device2023-11: 0 reports for this device; peer average 1.66/device2023-12: 0 reports for this device; peer average 1.74/device2024-01: 0 reports for this device; peer average 1.75/device2024-02: 0 reports for this device; peer average 2.04/device2024-03: 0 reports for this device; peer average 2.05/device2024-04: 0 reports for this device; peer average 1.86/device2024-05: 0 reports for this device; peer average 2.35/device2024-06: 0 reports for this device; peer average 2.06/device2024-07: 0 reports for this device; peer average 1.75/device2024-08: 0 reports for this device; peer average 2.12/device2024-09: 0 reports for this device; peer average 2.07/device2024-10: 0 reports for this device; peer average 1.83/device2024-11: 0 reports for this device; peer average 1.76/device2024-12: 0 reports for this device; peer average 1.63/device2025-01: 0 reports for this device; peer average 1.93/device2025-02: 0 reports for this device; peer average 1.57/device2025-03: 0 reports for this device; peer average 1.78/device2025-04: 0 reports for this device; peer average 1.83/device2025-05: 0 reports for this device; peer average 1.73/device2025-06: 0 reports for this device; peer average 1.84/device2025-07: 0 reports for this device; peer average 1.8/device2025-08: 0 reports for this device; peer average 1.75/device2025-09: 0 reports for this device; peer average 1.66/device2025-10: 0 reports for this device; peer average 1.71/device2025-11: 0 reports for this device; peer average 1.76/device2025-12: 0 reports for this device; peer average 1.87/device2026-01: 0 reports for this device; peer average 1.89/device2026-02: 0 reports for this device; peer average 1.7/device2026-03: 0 reports for this device; peer average 1.94/device2026-04: 0 reports for this device; peer average 1.88/device2026-05: 0 reports for this device; peer average 1.74/device2026-06: 0 reports for this device; peer average 1.79/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.28
2019-0202.1
2019-0302.3
2019-0402.27
2019-0501.86
2019-0601.64
2019-0701.59
2019-0801.99
2019-0901.88
2019-1002.13
2019-1101.93
2019-1202.12
2020-0102.43
2020-0202.18
2020-0302.68
2020-0402.03
2020-0501.89
2020-0601.83
2020-0702.3
2020-0801.88
2020-0902.28
2020-1002.25
2020-1102.03
2020-1202.11
2021-0102.14
2021-0201.88
2021-0301.89
2021-0401.89
2021-0501.86
2021-0602.19
2021-0702.19
2021-0802.14
2021-0902.36
2021-1002.12
2021-1101.9
2021-1202.05
2022-0101.93
2022-0201.98
2022-0302.01
2022-0401.98
2022-0502.12
2022-0602.02
2022-0702.02
2022-0802.1
2022-0902.17
2022-1002.08
2022-1102.17
2022-1201.98
2023-0102.26
2023-0202.03
2023-0302.13
2023-0402.24
2023-0502.1
2023-0602.26
2023-0702.21
2023-0801.99
2023-0902.03
2023-1001.68
2023-1101.66
2023-1201.74
2024-0101.75
2024-0202.04
2024-0302.05
2024-0401.86
2024-0502.35
2024-0602.06
2024-0701.75
2024-0802.12
2024-0902.07
2024-1001.83
2024-1101.76
2024-1201.63
2025-0101.93
2025-0201.57
2025-0301.78
2025-0401.83
2025-0501.73
2025-0601.84
2025-0701.8
2025-0801.75
2025-0901.66
2025-1001.71
2025-1101.76
2025-1201.87
2026-0101.89
2026-0201.7
2026-0301.94
2026-0401.88
2026-0501.74
2026-0601.79
This device (reports/month)Average device in LWJ, LZO, MEH, PLW (reports/device/month)

Regulatory clearances

  • K190834 SESE 2019-07-22 (k number procode)

Predicate lineage

K190834 — cites (transitively): K093472 (d1), K110087 (d1), K111481 (d1), K122305 (d1), K123705 (d1), K130128 (d1), K130343 (d1), K131647 (d1), K152893 (d1), K100412 (d2), K111863 (d2), K132788 (d2), K071535 (d3), K082844 (d3), K083762 (d3), K030047 (d3), K030055 (d3), K031454 (d3), K042989 (d3), K050124 (d3), K052996 (d3), K070369 (d3), K073449 (d3), K102795 (d3), K110555 (d3), K810120 (d3), K861114 (d3), K861433 (d3), K911685 (d3), K920639 (d3), K920640 (d3), K921181 (d3), K921277 (d3), K921301 (d3), K926107 (d3), K954417 (d3), K970501 (d3), K991990 (d3), K093806 (d3), K121115 (d3), K082358 (d4), K090988 (d4), K093533 (d4), K032396 (d4), K042037 (d4), K042051 (d4), K062995 (d4), K101336 (d4), K022949 (d4), K024096 (d4), K041119 (d4), K042962 (d4), K072022 (d4), K083393 (d4), K091445 (d4), K101074 (d4), K040962 (d5), K050981 (d5), K090390 (d5), K050327 (d5), K070364 (d5), K070399 (d5), K072020 (d5), K083116 (d5), K093644 (d5), K100048 (d5), K073102 (d6), K080528 (d6), K090103 (d6) — cited as predicate by K192656, K193042

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

Manufacturer compliance record — OPTIMIZED ORTHO PTY LTD

Nothing in the loaded window.