Klassic HD Low Profile Acetabular Insert with E-Link Poly
Model 3509.46.028 · TOTAL JOINT ORTHOPEDICS, INC. · DI 00814703015199
OQG — Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented · Class II · 21 CFR 888.3358
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 1.9 |
| 2019-02 | 0 | 2 |
| 2019-03 | 0 | 1.43 |
| 2019-04 | 0 | 1.67 |
| 2019-05 | 0 | 2 |
| 2019-06 | 0 | 1.77 |
| 2019-07 | 0 | 1.85 |
| 2019-08 | 0 | 1.47 |
| 2019-09 | 0 | 1.94 |
| 2019-10 | 0 | 1.63 |
| 2019-11 | 0 | 1.8 |
| 2019-12 | 0 | 1.69 |
| 2020-01 | 0 | 1.39 |
| 2020-02 | 0 | 1.61 |
| 2020-03 | 0 | 1.86 |
| 2020-04 | 0 | 1.37 |
| 2020-05 | 0 | 1.46 |
| 2020-06 | 0 | 1.26 |
| 2020-07 | 0 | 1.33 |
| 2020-08 | 0 | 1.47 |
| 2020-09 | 0 | 1.88 |
| 2020-10 | 0 | 1.24 |
| 2020-11 | 0 | 1.5 |
| 2020-12 | 0 | 1.7 |
| 2021-01 | 0 | 1.56 |
| 2021-02 | 0 | 1.38 |
| 2021-03 | 0 | 1.48 |
| 2021-04 | 0 | 1.49 |
| 2021-05 | 0 | 1.61 |
| 2021-06 | 0 | 1.52 |
| 2021-07 | 0 | 1.5 |
| 2021-08 | 0 | 1.41 |
| 2021-09 | 0 | 1.63 |
| 2021-10 | 0 | 1.63 |
| 2021-11 | 0 | 1.57 |
| 2021-12 | 0 | 1.76 |
| 2022-01 | 0 | 1.56 |
| 2022-02 | 0 | 1.41 |
| 2022-03 | 0 | 1.35 |
| 2022-04 | 0 | 1.49 |
| 2022-05 | 0 | 1.47 |
| 2022-06 | 0 | 1.54 |
| 2022-07 | 0 | 1.55 |
| 2022-08 | 0 | 1.46 |
| 2022-09 | 0 | 1.58 |
| 2022-10 | 0 | 1.28 |
| 2022-11 | 0 | 1.52 |
| 2022-12 | 0 | 1.52 |
| 2023-01 | 0 | 1.27 |
| 2023-02 | 0 | 1.26 |
| 2023-03 | 0 | 1.36 |
| 2023-04 | 0 | 1.54 |
| 2023-05 | 0 | 1.56 |
| 2023-06 | 0 | 1.42 |
| 2023-07 | 0 | 1.3 |
| 2023-08 | 0 | 1.33 |
| 2023-09 | 0 | 1.16 |
| 2023-10 | 0 | 1.14 |
| 2023-11 | 0 | 1.22 |
| 2023-12 | 0 | 1.4 |
| 2024-01 | 0 | 1.57 |
| 2024-02 | 0 | 1.12 |
| 2024-03 | 0 | 1.54 |
| 2024-04 | 0 | 1.33 |
| 2024-05 | 0 | 1.39 |
| 2024-06 | 0 | 1.39 |
| 2024-07 | 0 | 1.33 |
| 2024-08 | 0 | 1.37 |
| 2024-09 | 0 | 1.21 |
| 2024-10 | 0 | 1.3 |
| 2024-11 | 0 | 1.41 |
| 2024-12 | 0 | 1.16 |
| 2025-01 | 0 | 1.43 |
| 2025-02 | 0 | 1.26 |
| 2025-03 | 0 | 1.59 |
| 2025-04 | 0 | 1.58 |
| 2025-05 | 0 | 1.3 |
| 2025-06 | 0 | 1.59 |
| 2025-07 | 0 | 1.47 |
| 2025-08 | 0 | 1.39 |
| 2025-09 | 0 | 1.53 |
| 2025-10 | 0 | 1.54 |
| 2025-11 | 0 | 1.63 |
| 2025-12 | 0 | 1.89 |
| 2026-01 | 0 | 1.62 |
| 2026-02 | 0 | 1.3 |
| 2026-03 | 0 | 1.7 |
| 2026-04 | 0 | 1.88 |
| 2026-05 | 0 | 1.31 |
| 2026-06 | 0 | 1.38 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K180929 — cites (transitively): K100445 (d1), K141972 (d1), K143407 (d1), K161073 (d1), K173104 (d1), K030373 (d2), K062489 (d2), K073068 (d2), K082844 (d2), K052026 (d2), K103384 (d2), K000306 (d3), K042565 (d3), K062148 (d3) — cited as predicate by K213580, K220483, K221675
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — TOTAL JOINT ORTHOPEDICS, INC.
- NAI 2018-04-18 Total Joint Orthopedics, Inc. · 0 citations
- NAI 2018-04-18 Total Joint Orthopedics, Inc. · 0 citations