Stryker Leibinger GmbH & Co. KG
FREIBURG Baden-Wurttemberg, DE
STRYKER LEIBINGER GMBH & CO. KG appears in FDA device records in FREIBURG Baden-Wurttemberg, DE. FDA records list 22 510(k) clearances between and , 35 PMA records and one registered establishment. As of , FDA records show 25 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 22 510(k) clearances for Stryker Leibinger GmbH & Co. KG between 2009 and 2026. The busiest year on record is 2024, with 6. The most recent is 2026, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 2 |
| 2023 | 4 |
| 2024 | 6 |
| 2026 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261054 | RibPlate System | HRS | Substantially Equivalent | |
| K254233 | MEDPOR Customized Implant Kit | FWP | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K252871 | Spine Guidance 5.3 Software; Q Interbody Instruments; Elite Q Attachments; Elite Cutting Accessories | OLO | Substantially Equivalent | |
| K243491 | SternalPlate Expansion | HRS | Substantially Equivalent | |
| K241517 | Q Guidance System; Mako Spine System; | OLO | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K240651 | MRI Universal | JEY | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System | OLO | Substantially Equivalent | |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | DZL | Substantially Equivalent | |
| K231208 | Stryker Resorbable Fixation System | HBW | Substantially Equivalent | |
| K230733 | Stryker Resorbable Fixation System | JEY | Substantially Equivalent | |
| K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System | OLO | Substantially Equivalent | |
| K221855 | Universal CMF System | JEY | Substantially Equivalent | |
| K220593 | Spine Guidance Software, Stryker Q Guidance System | OLO | Substantially Equivalent | |
| K191916 | Stryker CMF MEDPOR Priority Customized Implant Kit | FWP | Substantially Equivalent | |
| K182425 | Universal Mesh - Sterile | GWO | Substantially Equivalent | |
| K162341 | Stryker OrthoMap Precision Knee system | OLO | Substantially Equivalent | |
| K141430 | VARIAX DISTAL RADIUS PLATING SYSTEM | HRS | Substantially Equivalent | |
| K093108 | STRYKER BIPOLAR FORCEPS | GEI | Substantially Equivalent | |
| K083009 | ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000 | OLO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 8010177 | 3002821504 | STRYKER LEIBINGER GMBH & CO. KG | BOTZINGER STRASSE 39-41, FREIBURG Baden-Wurttemberg D-79111 DE | 2026 | and 67 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- HRXArthroscope
- EHOBar, Preformed
- HTWBit, Drill
- HTTBurr, Orthopedic
- GEACannula, Surgical, General & Plastic Surgery
- FZOChisel, Surgical, Manual
- HXDClamp
- HQNConformer, Ophthalmic
- GXRCover, Burr Hole
- DZIDrill, Bone, Powered
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)
- DZJDriver, Wire, And Bone Drill, Manual
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- HBWFastener, Plate, Cranioplasty
- GENForceps, General & Plastic Surgery
- HTJGauge, Depth
- GDYGauze/Sponge, Internal, X-Ray Detectable
- GXDGenerator, Lesion, Radiofrequency
- FZXGuide, Surgical, Instrument
- HXKHolder, Needle; Orthopedic
- DZEImplant, Endosseous, Root-Form
- HPZImplant, Eye Sphere
- LRCInstrument, Ent Manual Surgical
- HAOInstrument, Surgical, Non-Powered
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- LFLInstrument, Ultrasonic Surgical
- FTDLamp, Surgical
- FTMMesh, Surgical
- EZXMesh, Surgical, Metal
- FTLMesh, Surgical, Polymeric
- GXPMethyl Methacrylate For Cranioplasty
- GEYMotor, Surgical Instrument, Ac-Powered
- HAWNeurological Stereotaxic Instrument
- DMGPapers, Ion
- HWQPasser
- HTYPin, Fixation, Smooth
- JEYPlate, Bone
- GWOPlate, Cranioplasty, Preformed, Alterable
- HRSPlate, Fixation, Bone
- JOFPolymer, Ent Synthetic, Porous Polyethylene
- GXIProbe, Radiofrequency Lesion
- FWPProsthesis, Chin, Internal
- KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- HSBRod, Fixation, Intramedullary And Accessories
- HWCScrew, Fixation, Bone
- DZLScrew, Fixation, Intraosseous
- HXXScrewdriver
- KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories
- LLZSystem, Image Processing, Radiological
- HWXTap, Bone
- HWTTemplate
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
- IRQUnit, Heating, Powered
- HTNWasher, Bolt Nut
- LRNWire, Surgical
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1885-2024 | 8000-021-002, Scopis ENT Software with TGS with Sofware Version: NOVA 3.6.0 RC16. Scopis is a next-generation solution for navigating functional endoscopic sinus surgery (FESS) offering surgeons highly advanced image guidance and visualization capabilities in a single system. The Stryker Electromagnetic Navigation Unit (8000-010-003) powered by Scopis ENT Software with TGS (8000-021-002), allows the analysis and identification of sinus cells in the complex patient anatomy and planning of the natural drainage pathways through the sinus cavity. During surgery, the planned pathways are overlaid in real-time onto the endoscopic image, providing a unique Scopis augmented reality technology. Guidance of endoscopic instruments may help perform a minimally invasive, accurate and selective surgery. | Unreleased software was installed on customer systems resulting in the visual feedback on the screen to show the points to be off from the physical reference point of the pointer or suction. | Class II | Open, Classified | |
| Z-1785-2024 | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleton. Catalog Number: 56-90614 | Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure | Class II | Open, Classified | |
| Z-1234-2023 | Patient-Fitted Temporomandibular (TMJ) Reconstruction Prosthesis | Device was shipped without having regulatory approval. | Class II | Open, Classified | |
| Z-0715-2022 | MEDPOR Titan OFW - MTB - Right - 1.0mm, Catalog number 81032 | Inside the packaging of one reported item a non-conforming product was found. Contrary to the design, the barrier layer was manufactured on the inferior side of the implant versus the superior side. | Class II | Terminated | |
| Z-1436-2021 | DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite. | Inability for the user to inject the paste from the syringe into the target location. | Class II | Terminated | |
| Z-2915-2018 | AXS PP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01548S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2914-2018 | AXS PP, 1X20MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01546S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2913-2018 | AXS PP, 1X14MM BURR HOLE COVER, 2 X 2-HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01544S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2912-2018 | AXS PP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01541S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2911-2018 | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01541S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2910-2018 | AXS PP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01540S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2909-2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01538S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2908-2018 | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01536S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2907-2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01534S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2906-2018 | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01532S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2905-2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01531S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2904-2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01530S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2903-2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01528S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2902-2018 | QUIKFLAP, 1X20MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01526S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2901-2018 | QUIKFLAP, 1X14MM BURR HOLE COVER, 2 X 2- HOLE PLATES, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01524S, for use on the cranium | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2900-2018 | QUIKFLAP, 3 X 2-HOLE PLATES WITH TAB, 1.5X4mm SELF DRILLING SCREWS, Part Number 12-01522S, for use on the cranium. | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2899-2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF TAPPING SCREWS, Part Number 12-01521S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher). | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-2898-2018 | QUIKFLAP, 3 X 2-HOLE DOG BONE PLATES WITH 1.5X4MM SELF DRILLING SCREWS, Part Number 12-01520S The Stryker QuickFlap Sterile Procedure Pack is intended for reconstruction, stabilization and/or rigid fixation of non-load bearing bony areas subsequent to craniotomy, craniectomy and cranial fractures in adults and adolescents (age 12 and higher). | After a three year term, there is a potential for the external packaging (sterile barrier) to become compromised. | Class II | Terminated | |
| Z-1150-2017 | 9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants | An incorrect sterility status on the label, non-sterile products labeled as sterile | Class II | Terminated | |
| Z-1149-2017 | QUINTUBE Monitor Pack (5 tubes/pk, 24 pk/case) (Non-Sterile) SPG Bulb Drain System, 4mm Flat w/Center Holes (Sterile) Accessories to TLS Surgical Drainage System | An incorrect sterility status on the label, non-sterile products labeled as sterile | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain