TOGGLELOC XL WITH ZIPLOOP
Model 110005089 · Biomet Orthopedics, LLC · DI 00880304567641
JDR — Staple, Fixation, Bone · Class II · 21 CFR 888.3030
MBI — Fastener, Fixation, Nondegradable, Soft Tissue · Class II · 21 CFR 888.3040
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 (2)
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: 1 · Malfunction: 1
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2019-01 | 0 | 4.13 |
| 2019-02 | 0 | 2.1 |
| 2019-03 | 0 | 2.9 |
| 2019-04 | 0 | 3 |
| 2019-05 | 0 | 2.86 |
| 2019-06 | 0 | 2.59 |
| 2019-07 | 0 | 3.24 |
| 2019-08 | 0 | 2.96 |
| 2019-09 | 0 | 3.2 |
| 2019-10 | 0 | 3.04 |
| 2019-11 | 0 | 4.34 |
| 2019-12 | 1 | 4.49 |
| 2020-01 | 0 | 4.46 |
| 2020-02 | 0 | 3.89 |
| 2020-03 | 0 | 3.58 |
| 2020-04 | 0 | 4.87 |
| 2020-05 | 0 | 3.38 |
| 2020-06 | 0 | 3.53 |
| 2020-07 | 0 | 3.27 |
| 2020-08 | 0 | 3.89 |
| 2020-09 | 0 | 3.62 |
| 2020-10 | 0 | 4.03 |
| 2020-11 | 0 | 5.44 |
| 2020-12 | 0 | 4.74 |
| 2021-01 | 0 | 3.99 |
| 2021-02 | 0 | 3.69 |
| 2021-03 | 0 | 3.53 |
| 2021-04 | 0 | 3.41 |
| 2021-05 | 0 | 3.89 |
| 2021-06 | 0 | 3.83 |
| 2021-07 | 0 | 3.6 |
| 2021-08 | 0 | 3.87 |
| 2021-09 | 0 | 3.87 |
| 2021-10 | 0 | 3.99 |
| 2021-11 | 0 | 4.2 |
| 2021-12 | 0 | 4.04 |
| 2022-01 | 0 | 3.82 |
| 2022-02 | 0 | 3.26 |
| 2022-03 | 0 | 3.71 |
| 2022-04 | 0 | 3.61 |
| 2022-05 | 0 | 3.65 |
| 2022-06 | 0 | 3.53 |
| 2022-07 | 0 | 3.37 |
| 2022-08 | 0 | 4.16 |
| 2022-09 | 0 | 3.66 |
| 2022-10 | 0 | 4.25 |
| 2022-11 | 0 | 2.78 |
| 2022-12 | 0 | 3.64 |
| 2023-01 | 0 | 3.47 |
| 2023-02 | 0 | 3.05 |
| 2023-03 | 0 | 3.7 |
| 2023-04 | 0 | 4.01 |
| 2023-05 | 0 | 4.38 |
| 2023-06 | 0 | 4.35 |
| 2023-07 | 0 | 3.52 |
| 2023-08 | 0 | 4.08 |
| 2023-09 | 0 | 4.3 |
| 2023-10 | 0 | 4.29 |
| 2023-11 | 0 | 4.33 |
| 2023-12 | 0 | 5.06 |
| 2024-01 | 0 | 5.15 |
| 2024-02 | 0 | 4.52 |
| 2024-03 | 0 | 4.4 |
| 2024-04 | 0 | 4.78 |
| 2024-05 | 0 | 5.85 |
| 2024-06 | 0 | 6.97 |
| 2024-07 | 0 | 3.86 |
| 2024-08 | 0 | 4.14 |
| 2024-09 | 0 | 4.74 |
| 2024-10 | 0 | 4.36 |
| 2024-11 | 0 | 4.26 |
| 2024-12 | 0 | 4.11 |
| 2025-01 | 0 | 4.98 |
| 2025-02 | 0 | 4.47 |
| 2025-03 | 0 | 4.27 |
| 2025-04 | 0 | 4.65 |
| 2025-05 | 0 | 5.22 |
| 2025-06 | 0 | 5.06 |
| 2025-07 | 0 | 4.88 |
| 2025-08 | 0 | 4.82 |
| 2025-09 | 0 | 4.25 |
| 2025-10 | 0 | 4.53 |
| 2025-11 | 0 | 5.05 |
| 2025-12 | 0 | 5.73 |
| 2026-01 | 1 | 4.89 |
| 2026-02 | 0 | 5.3 |
| 2026-03 | 0 | 5.66 |
| 2026-04 | 0 | 5.42 |
| 2026-05 | 0 | 6.15 |
| 2026-06 | 0 | 5.99 |
Regulatory clearances
- K173278 SESE 2018-01-05 (k number procode)
Predicate lineage
K130033 — cites (transitively): K083070 (d1), K102982 (d1), K980155 (d2) — cited as predicate by K133606, K140324, K141263, K151004, K153186, K170440, K173278, K200028, K203121, K211770, K220260, K220650, K231857, K233531, K242091
K173278 — cites (transitively): K130033 (d1), K083070 (d2), K102982 (d2), K980155 (d3) — cited as predicate by K240947
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Biomet Orthopedics, LLC
Nothing in the loaded window.