SMARTLOCK
Model 50-20596E · Stryker Leibinger GmbH & Co. KG · DI 04546540732040
DZL — Screw, Fixation, Intraosseous · Class II · 21 CFR 872.4880
UDILibrary device dossier · generated 2026-09-12 · 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 |
| 2019-02 | 0 | 1.33 |
| 2019-03 | 0 | 1.63 |
| 2019-06 | 0 | 4 |
| 2019-07 | 0 | 1.5 |
| 2019-08 | 0 | 1 |
| 2019-09 | 0 | 2 |
| 2019-10 | 0 | 1.5 |
| 2019-11 | 0 | 2.25 |
| 2019-12 | 0 | 1.4 |
| 2020-01 | 0 | 1.7 |
| 2020-02 | 0 | 1.5 |
| 2020-03 | 0 | 1.5 |
| 2020-04 | 0 | 2 |
| 2020-06 | 0 | 1 |
| 2020-07 | 0 | 1 |
| 2020-08 | 0 | 2.29 |
| 2020-09 | 0 | 1.5 |
| 2020-10 | 0 | 1 |
| 2020-11 | 0 | 1 |
| 2020-12 | 0 | 1.43 |
| 2021-01 | 0 | 2.5 |
| 2021-02 | 0 | 2.5 |
| 2021-03 | 0 | 2 |
| 2021-04 | 0 | 2.8 |
| 2021-05 | 0 | 1.33 |
| 2021-06 | 0 | 3 |
| 2021-07 | 0 | 1 |
| 2021-08 | 0 | 1.67 |
| 2021-09 | 0 | 1.5 |
| 2021-10 | 0 | 1.25 |
| 2021-11 | 0 | 1 |
| 2021-12 | 0 | 2.75 |
| 2022-01 | 0 | 3 |
| 2022-02 | 0 | 1.5 |
| 2022-03 | 0 | 2 |
| 2022-04 | 0 | 2.5 |
| 2022-05 | 0 | 15.33 |
| 2022-06 | 0 | 1 |
| 2022-07 | 0 | 2 |
| 2022-08 | 0 | 4 |
| 2022-09 | 0 | 2 |
| 2022-10 | 0 | 7.83 |
| 2022-11 | 0 | 3.33 |
| 2022-12 | 0 | 7.35 |
| 2023-01 | 0 | 2.67 |
| 2023-02 | 0 | 2 |
| 2023-03 | 0 | 8.88 |
| 2023-05 | 0 | 2.33 |
| 2023-06 | 0 | 2.5 |
| 2023-07 | 0 | 2 |
| 2023-08 | 0 | 1 |
| 2023-09 | 0 | 2.75 |
| 2023-10 | 0 | 1.14 |
| 2023-11 | 0 | 1.33 |
| 2023-12 | 0 | 3.5 |
| 2024-01 | 0 | 5 |
| 2024-02 | 0 | 2.5 |
| 2024-03 | 0 | 1.33 |
| 2024-04 | 0 | 1.25 |
| 2024-05 | 0 | 2 |
| 2024-06 | 0 | 1 |
| 2024-07 | 0 | 2.5 |
| 2024-08 | 0 | 1 |
| 2024-09 | 0 | 3.33 |
| 2024-10 | 0 | 1.17 |
| 2024-11 | 0 | 1 |
| 2024-12 | 0 | 2 |
| 2025-01 | 0 | 2.4 |
| 2025-02 | 0 | 1 |
| 2025-04 | 0 | 1 |
| 2025-05 | 0 | 1 |
| 2025-06 | 0 | 2.5 |
| 2025-07 | 0 | 1.33 |
| 2025-08 | 0 | 2.33 |
| 2025-09 | 0 | 2 |
| 2025-10 | 0 | 2 |
| 2025-11 | 0 | 1.67 |
| 2025-12 | 0 | 1 |
| 2026-01 | 0 | 1 |
| 2026-02 | 0 | 1 |
| 2026-03 | 0 | 1 |
| 2026-04 | 0 | 1.4 |
| 2026-05 | 0 | 1 |
| 2026-06 | 0 | 1.67 |
Regulatory clearances
- None linked in the loaded window.
Predicate lineage
K122313 — cites (transitively): K050535 (d1), K061271 (d1) — cited as predicate by K141165, K143336, K173320, K231599, K240651, K252246
K240651 — cites (transitively): K050535 (d1), K122313 (d1), K133461 (d1), K171364 (d1), K172572 (d1), K221855 (d1), K231599 (d1), K980364 (d1), K061271 (d2), K123786 (d2), K014263 (d2), K022185 (d2), K031659 (d2), K080331 (d3)
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Stryker Leibinger GmbH & Co. KG
- NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
- NAI 2017-07-27 Stryker Leibinger GmbH & Co. KG · 0 citations
- NAI 2013-11-14 Stryker Leibinger GmbH & Co. KG · 0 citations