Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Stryker Leibinger GmbH & Co KG · Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
142 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | 2026-07-01 | 92 | 0 |
| K254233 | MEDPOR Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2026-03-12 | 73 | 0 |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spi | Stryker Leibinger GmbH & Co KG | 2026-02-19 | 93 | 0 |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite | Stryker Leibinger GmbH & Co KG | 2026-02-06 | 149 | 0 |
| K243491 | SternalPlate Expansion | Stryker Leibinger GmbH & Co KG | 2024-12-11 | 29 | 0 |
| K241517 | Q Guidance System; Mako Spine System; | Stryker Leibinger GmbH & Co KG | 2024-08-27 | 90 | 0 |
| K241171 | Spine Guidance Software (Version 5.1); Consolidated Operatin | Stryker Leibinger GmbH & Co KG | 2024-07-25 | 90 | 0 |
| K240651 | MRI Universal | Stryker Leibinger GmbH & Co KG | 2024-07-12 | 127 | 0 |
| K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Inst | Stryker Leibinger GmbH & Co KG | 2024-06-06 | 90 | 0 |
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Expre | Stryker Leibinger GmbH & Co KG | 2024-03-14 | 132 | 0 |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker Leibinger GmbH & Co KG | 2023-08-24 | 84 | 0 |
| K231208 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023-08-14 | 109 | 0 |
| K230733 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | 2023-08-05 | 142 | 0 |
| K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Expre | Stryker Leibinger GmbH & Co KG | 2023-02-13 | 60 | 0 |
| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | 2022-11-09 | 135 | 0 |
| K220593 | Spine Guidance Software, Stryker Q Guidance System | Stryker Leibinger GmbH & Co KG | 2022-05-27 | 87 | 0 |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit | Stryker Leibinger GmbH & Co KG | 2019-08-15 | 29 | 0 |
| K182425 | Universal Mesh - Sterile | Stryker Leibinger GmbH & Co KG | 2018-11-06 | 61 | 1 |
| K162341 | Stryker OrthoMap Precision Knee system | Stryker Leibinger GmbH & Co KG | 2016-10-12 | 51 | 0 |
| K141430 | VARIAX DISTAL RADIUS PLATING SYSTEM | Stryker Leibinger GmbH & Co KG | 2014-07-18 | 49 | 0 |
| K093108 | STRYKER BIPOLAR FORCEPS | Stryker Leibinger GmbH & Co KG | 2010-06-22 | 264 | 0 |
| K083009 | ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, | Stryker Leibinger GmbH & Co KG | 2009-02-19 | 133 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda