Unnamed device
Model 458.830S · SYNTHES (U.S.A.) LP · DI 10886982230201
HWC — Screw, Fixation, Bone · Class II · 21 CFR 888.3040
JDS — Nail, Fixation, Bone · Class II · 21 CFR 888.3030
UDILibrary device dossier · generated 2026-09-14 · 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 | 2.09 |
| 2019-02 | 0 | 1.61 |
| 2019-03 | 0 | 1.58 |
| 2019-04 | 0 | 2.05 |
| 2019-05 | 0 | 1.79 |
| 2019-06 | 0 | 1.82 |
| 2019-07 | 0 | 2.09 |
| 2019-08 | 0 | 2.02 |
| 2019-09 | 0 | 1.66 |
| 2019-10 | 0 | 1.73 |
| 2019-11 | 0 | 2.01 |
| 2019-12 | 0 | 2.48 |
| 2020-01 | 0 | 2.46 |
| 2020-02 | 0 | 2.13 |
| 2020-03 | 0 | 1.87 |
| 2020-04 | 0 | 1.87 |
| 2020-05 | 0 | 1.7 |
| 2020-06 | 0 | 2.08 |
| 2020-07 | 0 | 2.58 |
| 2020-08 | 0 | 2.42 |
| 2020-09 | 0 | 2.46 |
| 2020-10 | 0 | 2.19 |
| 2020-11 | 0 | 2.76 |
| 2020-12 | 0 | 2.38 |
| 2021-01 | 0 | 1.83 |
| 2021-02 | 0 | 2.25 |
| 2021-03 | 0 | 2.54 |
| 2021-04 | 0 | 2.67 |
| 2021-05 | 0 | 2.36 |
| 2021-06 | 0 | 2.17 |
| 2021-07 | 0 | 2.23 |
| 2021-08 | 0 | 2.28 |
| 2021-09 | 0 | 2.29 |
| 2021-10 | 0 | 2.06 |
| 2021-11 | 0 | 2.21 |
| 2021-12 | 0 | 2.32 |
| 2022-01 | 0 | 2.83 |
| 2022-02 | 0 | 2.24 |
| 2022-03 | 0 | 1.99 |
| 2022-04 | 0 | 1.9 |
| 2022-05 | 0 | 2.31 |
| 2022-06 | 0 | 2.25 |
| 2022-07 | 0 | 2.19 |
| 2022-08 | 0 | 2.47 |
| 2022-09 | 0 | 3.06 |
| 2022-10 | 0 | 3.01 |
| 2022-11 | 0 | 3.08 |
| 2022-12 | 0 | 5.07 |
| 2023-01 | 0 | 2.79 |
| 2023-02 | 0 | 2.96 |
| 2023-03 | 0 | 3.27 |
| 2023-04 | 0 | 2.8 |
| 2023-05 | 0 | 3.42 |
| 2023-06 | 0 | 3.07 |
| 2023-07 | 0 | 2.34 |
| 2023-08 | 0 | 2.16 |
| 2023-09 | 0 | 1.99 |
| 2023-10 | 0 | 2.09 |
| 2023-11 | 0 | 1.83 |
| 2023-12 | 0 | 2.39 |
| 2024-01 | 0 | 2.77 |
| 2024-02 | 0 | 1.81 |
| 2024-03 | 0 | 2.33 |
| 2024-04 | 0 | 2.1 |
| 2024-05 | 0 | 2.25 |
| 2024-06 | 0 | 2.26 |
| 2024-07 | 0 | 2.36 |
| 2024-08 | 0 | 2.11 |
| 2024-09 | 0 | 2.16 |
| 2024-10 | 0 | 2.21 |
| 2024-11 | 0 | 2.15 |
| 2024-12 | 0 | 2.73 |
| 2025-01 | 0 | 2.31 |
| 2025-02 | 0 | 2.26 |
| 2025-03 | 0 | 2.11 |
| 2025-04 | 0 | 2.87 |
| 2025-05 | 0 | 2.55 |
| 2025-06 | 0 | 2.02 |
| 2025-07 | 0 | 2.21 |
| 2025-08 | 0 | 2.41 |
| 2025-09 | 0 | 2.15 |
| 2025-10 | 0 | 2.53 |
| 2025-11 | 0 | 2.22 |
| 2025-12 | 0 | 2.86 |
| 2026-01 | 0 | 2.14 |
| 2026-02 | 0 | 2.46 |
| 2026-03 | 0 | 2.59 |
| 2026-04 | 0 | 2.16 |
| 2026-05 | 0 | 2.57 |
| 2026-06 | 0 | 2.33 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K000089 — cited as predicate by K113733, K120807, K160553, K160946, K171108, K192003, K201336, K201346
K040762 — cited as predicate by K111667, K131609, K143245, K160553, K171108, K180436, K191617, K192003, K193308, K201336, K210285, K230071
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — SYNTHES (U.S.A.) LP
Nothing in the loaded window.