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RingLoc Hip System

Model EP-108524 · Biomet Orthopedics, LLC · DI 00880304468962

JDI — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented · Class II · 21 CFR 888.3350

JWH — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer · Class II · 21 CFR 888.3560

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

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

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

OIY — Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive · Class II · 21 CFR 888.3560

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

OQH — Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented · Class II · 21 CFR 888.3350

OQI — Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented · Class II · 21 CFR 888.3353

UDILibrary device dossier · generated 2026-09-07 · 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 (3)

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.

Injury: 3

11232019-01: 0 reports for this device; peer average 2.85/device2019-02: 0 reports for this device; peer average 2.47/device2019-03: 0 reports for this device; peer average 2.56/device2019-04: 0 reports for this device; peer average 2.55/device2019-05: 0 reports for this device; peer average 2.1/device2019-06: 0 reports for this device; peer average 1.97/device2019-07: 0 reports for this device; peer average 1.96/device2019-08: 0 reports for this device; peer average 2.26/device2019-09: 0 reports for this device; peer average 2.31/device2019-10: 0 reports for this device; peer average 2.65/device2019-11: 0 reports for this device; peer average 2.61/device2019-12: 0 reports for this device; peer average 2.53/device2020-01: 0 reports for this device; peer average 2.71/device2020-02: 1 reports for this device; peer average 2.62/device2020-03: 0 reports for this device; peer average 2.89/device2020-04: 0 reports for this device; peer average 2.2/device2020-05: 0 reports for this device; peer average 2.08/device2020-06: 0 reports for this device; peer average 2.04/device2020-07: 0 reports for this device; peer average 2.52/device2020-08: 1 reports for this device; peer average 2.18/device2020-09: 0 reports for this device; peer average 2.38/device2020-10: 0 reports for this device; peer average 2.64/device2020-11: 0 reports for this device; peer average 2.5/device2020-12: 0 reports for this device; peer average 2.55/device2021-01: 0 reports for this device; peer average 2.4/device2021-02: 0 reports for this device; peer average 2.16/device2021-03: 0 reports for this device; peer average 2.23/device2021-04: 0 reports for this device; peer average 2.16/device2021-05: 0 reports for this device; peer average 2.11/device2021-06: 0 reports for this device; peer average 2.36/device2021-07: 0 reports for this device; peer average 2.3/device2021-08: 0 reports for this device; peer average 2.15/device2021-09: 0 reports for this device; peer average 2.35/device2021-10: 0 reports for this device; peer average 2.1/device2021-11: 0 reports for this device; peer average 2.13/device2021-12: 0 reports for this device; peer average 2.31/device2022-01: 0 reports for this device; peer average 2.03/device2022-02: 0 reports for this device; peer average 2.12/device2022-03: 0 reports for this device; peer average 2.1/device2022-04: 0 reports for this device; peer average 2.11/device2022-05: 0 reports for this device; peer average 2.15/device2022-06: 0 reports for this device; peer average 2.13/device2022-07: 0 reports for this device; peer average 2.08/device2022-08: 0 reports for this device; peer average 2.11/device2022-09: 0 reports for this device; peer average 2.17/device2022-10: 0 reports for this device; peer average 2.11/device2022-11: 0 reports for this device; peer average 2.2/device2022-12: 0 reports for this device; peer average 2.04/device2023-01: 0 reports for this device; peer average 2.13/device2023-02: 0 reports for this device; peer average 2.11/device2023-03: 0 reports for this device; peer average 2.24/device2023-04: 0 reports for this device; peer average 2.22/device2023-05: 0 reports for this device; peer average 2.2/device2023-06: 0 reports for this device; peer average 2.18/device2023-07: 0 reports for this device; peer average 2.04/device2023-08: 0 reports for this device; peer average 1.88/device2023-09: 0 reports for this device; peer average 1.85/device2023-10: 0 reports for this device; peer average 1.62/device2023-11: 0 reports for this device; peer average 1.63/device2023-12: 0 reports for this device; peer average 1.71/device2024-01: 0 reports for this device; peer average 1.69/device2024-02: 0 reports for this device; peer average 1.89/device2024-03: 0 reports for this device; peer average 1.89/device2024-04: 0 reports for this device; peer average 1.71/device2024-05: 0 reports for this device; peer average 1.98/device2024-06: 0 reports for this device; peer average 1.91/device2024-07: 0 reports for this device; peer average 1.75/device2024-08: 0 reports for this device; peer average 2.01/device2024-09: 0 reports for this device; peer average 1.97/device2024-10: 0 reports for this device; peer average 1.82/device2024-11: 0 reports for this device; peer average 1.79/device2024-12: 0 reports for this device; peer average 1.69/device2025-01: 0 reports for this device; peer average 1.98/device2025-02: 0 reports for this device; peer average 1.59/device2025-03: 0 reports for this device; peer average 1.73/device2025-04: 0 reports for this device; peer average 1.73/device2025-05: 0 reports for this device; peer average 1.68/device2025-06: 0 reports for this device; peer average 1.77/device2025-07: 0 reports for this device; peer average 1.71/device2025-08: 0 reports for this device; peer average 1.65/device2025-09: 0 reports for this device; peer average 1.69/device2025-10: 0 reports for this device; peer average 1.62/device2025-11: 0 reports for this device; peer average 1.73/device2025-12: 0 reports for this device; peer average 1.79/device2026-01: 0 reports for this device; peer average 1.78/device2026-02: 1 reports for this device; peer average 1.57/device2026-03: 0 reports for this device; peer average 1.9/device2026-04: 0 reports for this device; peer average 1.79/device2026-05: 0 reports for this device; peer average 1.68/device2026-06: 0 reports for this device; peer average 1.68/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.85
2019-0202.47
2019-0302.56
2019-0402.55
2019-0502.1
2019-0601.97
2019-0701.96
2019-0802.26
2019-0902.31
2019-1002.65
2019-1102.61
2019-1202.53
2020-0102.71
2020-0212.62
2020-0302.89
2020-0402.2
2020-0502.08
2020-0602.04
2020-0702.52
2020-0812.18
2020-0902.38
2020-1002.64
2020-1102.5
2020-1202.55
2021-0102.4
2021-0202.16
2021-0302.23
2021-0402.16
2021-0502.11
2021-0602.36
2021-0702.3
2021-0802.15
2021-0902.35
2021-1002.1
2021-1102.13
2021-1202.31
2022-0102.03
2022-0202.12
2022-0302.1
2022-0402.11
2022-0502.15
2022-0602.13
2022-0702.08
2022-0802.11
2022-0902.17
2022-1002.11
2022-1102.2
2022-1202.04
2023-0102.13
2023-0202.11
2023-0302.24
2023-0402.22
2023-0502.2
2023-0602.18
2023-0702.04
2023-0801.88
2023-0901.85
2023-1001.62
2023-1101.63
2023-1201.71
2024-0101.69
2024-0201.89
2024-0301.89
2024-0401.71
2024-0501.98
2024-0601.91
2024-0701.75
2024-0802.01
2024-0901.97
2024-1001.82
2024-1101.79
2024-1201.69
2025-0101.98
2025-0201.59
2025-0301.73
2025-0401.73
2025-0501.68
2025-0601.77
2025-0701.71
2025-0801.65
2025-0901.69
2025-1001.62
2025-1101.73
2025-1201.79
2026-0101.78
2026-0211.57
2026-0301.9
2026-0401.79
2026-0501.68
2026-0601.68
This device (reports/month)Average device in JDI, JWH, LPH, LWJ, LZO, MAY, OIY, OQG, OQH, OQI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K090103 — cited as predicate by K100048

K100048 — cites (transitively): K070364 (d1), K070399 (d1), K073102 (d1), K080528 (d1), K090103 (d1) — cited as predicate by K101336, K122529, K190100, K211877

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

Manufacturer compliance record — Biomet Orthopedics, LLC

Nothing in the loaded window.