stimOS Product Portfolio
Implants & Instruments / Surface Functionalization / Patient Specific Devices / Regulatory Services
stimOS offers its products and services to small, medium-sized but also to larger enterprises.
Mimicking Bone Technology
Surface Functionalization Support
With its new and sustainable surface functionalization technologies, stimOS offers the various market players the best technology currently available on the market. stimOS provides MBT both as a service but also in the form of licensing to industrial partners, offering solutions for manufacturers, in the sector of conventional and patient specific solutions. All our surface technologies meet the requiements of MDR and are certified according to the S.P.E.L standard.
spineFuse Implant System
Stealth Technology for Implants
spineFuse implants follow the patient’s anatomy of the spine and are designed to restore the natural shape of the spinal column. Sliding struts [1] on the implants body and it´s bullet nose [2] guarantee an easy insertion. The anatomical implant design [3] guarantees a perfect fit. Carved out bone-anchorage struts [4] allow bone cells to better adhere to the implant´s surface by providing ideal grip. MBT surface modification and finish [5] provide for an enlarged surface topography [6] resulting in optimal primary stability and best anchorage of the implant - avoiding migration and subsidence.
spineFuse Instruments
Sterile delivered Instrument Set
spineFuse instruments are designed to guarantee exact placement of spinFuse implants. Instrument sets can be provided sterile packed or for re-use.
Manufacturing Material Support
Additional Services from our Polymer Experts
We assist our customers in defining material specifications to choose the optimal polymer matching best the requirements for YOUR product: implant, instrument or surgical tool: The right choice of material makes the difference.
Product Qualification Support
Implementing International Quality Standards
Our regulatory specialists help YOU to qualify YOUR medical device. No matter if conventional implant, instrument or tool - or patient specific medical device, component or accessory, together we define the regulatory strategy to meet international standards and to comply with the requirements given by the Medical Device Regulation / MDR. To address patient specific implants and smart implant surfaces, stimOS has defined and set effective the quality standard S.P.E.L. (check here: S.P.E.L. Surface Technology / check here: S.P.E.L 3D Manufacturing) This was done in close cooperation with Notified Bodies and Certification Agencies to provide our customers best-in-class regulatory expertise.
Patient Specific Implants
stimOS Competence Center offering Best-in-Class Solutions
stimOS assists its customers in exactly defining and validating their 3D printing parameters to produce and market products qualified for the use as medical devices - serial or patient specific implants or instruments - or to be used as assisting tools in planning and executing surgery. stimOS Competence Center Services offer design and development work, printing services (together with leading industrial partners), surface modifications and certification services.
In a pilot project, we also applied S.P.E.L the newly introduced evidence level standard to all the development and analysis activities and calculated the level for the biomimetic surface functionalization technology: stimOS MBT. The scoring system is divided into 6 subsections: Design and development, manufacturing, mechanical testing, biocompatibility testing, animal study, clinical applicability.
MBT design and development planning and executing followed a defined approach according ISO 13485:2016 requirements. Verification activities started parallel to the development work, assisted by ISO 14971, ISO 62366 and ISO 10993 measurement methods.
The manufacturing process is verified and validiated according GLP standards. The company is an ISO 13485:2016 certified Legal Manufacturer. The next industrial upscale of the technology will be subject of the next yearly surveillance audit.
Mechanical testing followed a precise defined test and verification matrix. Each test followed an own rationale and test setup. Where possible, standard tests methods and accredited facilities have been used.
During design and development and during design transfer comparative cell tests have been performed by the company. Relevant cell lines have been used to prove the unique characteristics of MBT compared to standard and golden standard materials: Titanium coated PEEK, Ha-enhanced PEEK, PEEK.
A comparative animal model has been performed according GLP standards by Vetsuisse Zurich. The study protocol was approved by the veterinarians of the Kanton ZH. A comparative split mouth study set up was used.
Our modification method will not influence the applicability of the related medical device. Surgical technique, storage, packaging, cleaning, and sterilization requirements of the implant incorporating MBT are not affected by this high-performance technology.
For the technology in scope the overall evidence level (S.P.E.L.) can be indicated with 94,3 %.
Comparative Animal Model
stimOS GmbH I Vetsuisse University of Zurich I Charité Universitätsmedizin Berlin
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Study Setup
Initially, a total of 36 cylindrical implants with an external thread (diameter: 3.55 mm, length: 8 mm) were produced by turning from round rods of the following three implant materials: Pure Titanium, pure PEEK, HA enhanced PEEK (Invibio Ltd.).
The well described and reliable pelvic sheep model was used for the study because of the transferability to humans. The implants were installed in the cranial part of the left (n = 6) and right (n = 6) pelvis of each animal (Fig.1), whereas their position alternated on either side of the linea glutea of the iliac bone. The animals were sacrificed 8 weeks postoperatively and the n = 6 implants of each implant group were examined histologically.
The test implants made from pure PEEK have been functionalised using stimOS MBT technology. stimOS has already achieved ISO 13485:2016 certification by verification and validation of MBT processes. The technology has passed regulatory clearance.
>> see section below to study the animal model test results.
