Stryker Leibinger GmbH & Co KG: FDA clearances and approvals
Stryker Leibinger GmbH & Co KG has 22 FDA 510(k) clearances (first 2009, latest 2026), plus 2 PMA decisions, across 10 product codes in 4 review panels. Median 510(k) review time: 90 days. Since 2017 its median was 90 days, against 104 days for all cleared 510(k)s in the same product codes. openFDA lists 25 product recalls by a recalling firm named Stryker Leibinger GmbH & Co KG.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 49 |
| 2015 | 0 | — |
| 2016 | 1 | 51 |
| 2017 | 0 | — |
| 2018 | 1 | 61 |
| 2019 | 1 | 29 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 111 |
| 2023 | 4 | 96 |
| 2024 | 6 | 90 |
| 2025 | 0 | — |
| 2026 | 4 | 92 |
Review time against the same product codes
Since 2017, Stryker Leibinger GmbH & Co KG's cleared 510(k)s took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 10 | 10 |
| HRS | Plate, Fixation, Bone | 3 | 3 |
| JEY | Plate, Bone | 3 | 3 |
| FWP | Prosthesis, Chin, Internal | 2 | 2 |
| DZL | Screw, Fixation, Intraosseous | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| HBW | Fastener, Plate, Cranioplasty | 1 | 1 |
| LZD | Joint, Temporomandibular, Implant | 1 | 0 |
| NQR | Sealant, Dural | 1 | 0 |
Review panels
- Orthopedic (13)
- Dental (5)
- Neurology (3)
- General and Plastic Surgery (3)
Most recent Stryker Leibinger GmbH & Co KG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261054 | RibPlate System | HRS | 2026-07-01 | 92 |
| K254233 | MEDPOR Customized Implant Kit | FWP | 2026-03-12 | 73 |
| K253623 | Spine Guidance 5.4 Software; Spine Guidance 5.4 Upgrade; Spine Guidance 5.4 Update; Spine Guidance 5.4 Software Enable; Spine Guidance 5.4 Sales Demo; Q Drill Tracker; NavLock Adapter; Elite Q Attacments; Elite Cutting Accessories; Maestro Air Motor | OLO | 2026-02-19 | 93 |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | OLO | 2026-02-06 | 149 |
| K243491 | SternalPlate Expansion | HRS | 2024-12-11 | 29 |
| K241517 | Q Guidance System; Mako Spine System; | OLO | 2024-08-27 | 90 |
| K241171 | Spine Guidance Software (Version 5.1); Consolidated Operating Room Equipment (CORE) 2 Console; CORE Q Footswitch; PI Drive 2 Motors; Elite Q Attachments and Cutting Accessories | OLO | 2024-07-25 | 90 |
| K240651 | MRI Universal | JEY | 2024-07-12 | 127 |
| K240662 | Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary Handpiece | OLO | 2024-06-06 | 90 |
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System | OLO | 2024-03-14 | 132 |
12 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P130014 | PMA | ADHERUS AUTOSPRAY DURAL SEALANT | 2015-03-30 |
| P980052 | PMA | TMJ CONCEPTS PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS | 1999-07-02 |
Recalls
25 product recalls in 7 recall events; 4 initiated in the last five years. Most recent: 2024-04-04.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Stryker Leibinger GmbH & Co KG have?
Stryker Leibinger GmbH & Co KG has 22 FDA 510(k) clearances (first 2009, latest 2026), plus 2 PMA decisions, across 10 product codes in 4 review panels.
How long does FDA take to clear Stryker Leibinger GmbH & Co KG's 510(k)s?
The median time from FDA receipt to decision across Stryker Leibinger GmbH & Co KG's cleared 510(k)s is 90 days. Since 2017: 90 days, versus 104 days for all cleared 510(k)s in the same product codes.
What devices does Stryker Leibinger GmbH & Co KG make?
Its most frequent FDA product codes are OLO (Orthopedic Stereotaxic Instrument, 10); HRS (Plate, Fixation, Bone, 3); JEY (Plate, Bone, 3).
Has Stryker Leibinger GmbH & Co KG had device recalls?
openFDA lists 25 product recalls in 7 recall events by a recalling firm whose name matches Stryker Leibinger GmbH & Co KG; the most recent began 2024-04-04. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 22 Stryker Leibinger GmbH & Co KG clearances with predicates and recalls
- Run predicate analysis for product code OLO, Stryker Leibinger GmbH & Co KG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.