KLS Martin IPS Implants®
MODEL
IPS Implants®
HSN CODE
90185090
EAN UPC CODE
EAN - NA
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Brand:
KLS Martin India Pvt Ltd
Category:
Individual Patient Solutions
DETAILS
KLS Martin IPS Implants®
The right "customized" choice for every patient
Patient-specific implants, planning aids, and anatomical models are made from various materials using state-of-the-art fabrication technologies. Thanks to computer-based planning and functionalized patient-specific implants, preoperative planning can be implemented in surgery with unprecedented precision.
Based on the potential planning in our IPS CaseDesigner® software and subsequent case treatment and communication in the IPS Gate®, you will then receive an IPS® implant fabricated to your wishes. As a result, the IPS® product range offers a versatile service in terms of patient-specific implants.
Generative manufacturing process, additive manufacturing
Selective laser melting (SLM) is a 3D printing process in the context of a generative manufacturing process.
Titanium powder is fed from a high pressure chamber into a working chamber via a scraper or roller. A laser beam is reflected into the working chamber with a mirror where it falls on the titanium powder. The impact of the laser beam melts the powder (hence the term laser melting) and compresses it. Once the laser has processed one working plane, the working platform (table) is lowered and a new layer of titanium powder is applied. Thus the workpiece is manufactured layer after layer. As the performance density of the laser is extremely high, this leads to highly compressed three-dimensional workpieces. This manufacturing process allows the fabrication of patient-specific implants from additive manufactured titanium.
Selective laser sintering and stereolithography
Selective laser sintering and stereolithography also count as generative manufacturing processes. Selective laser sintering (SLS) follows the same functional principle as selective laser melting, the difference being that the starting materials used are all materials with thermoplastic properties. Resin powder (e.g. polyamide (PA)) is a frequently used material. Drill and marking guides or anatomical models are manufactured using this method.
In stereolithography (SLA), the workpiece is positioned in a photopolymer liquid bath (e.g. epoxy resin) in which it is slowly immersed deeper and deeper. During each step a laser passes over the starting material to harden it in thin layers in order to create the desired shape.
The stereolithography process is the 3D printing process which has so far been in use the longest, so that a considerable amount of
experience has been gained. In general this method is used for fabricating anatomical models.
Conventional manufacturing technologies
PEEK, titanium mesh and solid titanium implants are fabricated with proven conventional manufacturing processes. This includes deep-drawing, milling, turning, or machining.
Additive manufacturing titanium
Completely free surfaces can be generated without tools and devices. This allows for hitherto unprecedented options in surface design. Correction processes are no longer required.
Material: Ti-alloy Ti6Al4V
Specified according to: ASTM F136 -02a (ELI Grade 23)
Sterilization: steam sterilization at 132 °C
EN 285 / ANSIA / AAMI / ISO 11134 – 1993
Benefits
Complete freedom of design of the material and its surface
Exact precision fit
High stability
Open structures are possible
Fast
Limitations
If necessary, revision procedures are only possible with considerable effort
Intraoperative trimming is virtually impossible
PEEK - poly ether ether ketone
Brief information: PEEK is a high-strength, temperature-stable high performance polymer. Due to its physical properties, which closely resemble those of human cortical bone, it is the most commonly used plastic in orthopedics. Available in closed or pre-drilled designs.
Material: - poly ether ether ketone
Specified according to: ISO 10993, ASTM F 2026
Sterilization: steam sterilization at 132 °C
EN 285 / ANSIA / AAMI / ISO 11134 – 1993
Benefits
Very elastic, yet very hard and resistant at the same time
Optimal protective function for the patient
No increased thermal sensitivity
Low weight
Resistant to gamma irradiation and MRT imaging
Low formation of artefacts on X-ray images
Three-dimensional bone replacement
Limitations
Only limited accumulation potential of cells
Intraoperative adaptation or trimming is only possible at considerable effort
Requires osteosynthesis plates for fixation
Titanium mesh
Compared with conventional osteosynthesis materials, titanium mesh is deep-drawn three-dimensionally. A special thermal process provides a closed material structure and best mechanical strength. The mesh is form-stable and not pre-damaged. Titanium mesh has excellent biocompatibility and offers accumulation potential for bone cells.
Material: pure titanium
Specified according to: ISO 5832-2, ASTM F 67
Sterilization: steam sterilization at 132 °C
EN 285 / ANSIA / AAMI / ISO 11134 – 1993
Benefits
Best biocompatibility, best vascularization
Beneficial mechanical properties
Easy final adaptation is also possible during the surgical procedure
Good trimming properties
Accumulation potential for bone cells
Optimal material for involved nasal sinuses
Comparatively lower price levels
No osteosynthesis plates required for fixation
Limitations
No three-dimensional bone replacement
Tools required
Solid titanium
Solid titanium is a high-strength reconstruction alternative to titanium mesh. Although it has been largely replaced by titanium mesh over the past few years, it still offers some advantages in certain applications - e.g. in terms of mechanical protection.
Material: pure titanium
Specified according to: ISO 5832-3, ASTM F 67
Sterilization: steam sterilization at 132 °C
EN 285 / ANSIA / AAMI / ISO 11134 – 1993
Benefits
High-strength reconstruction alternative
Best mechanical protective function
Complete three-dimensional replica of the defect under consideration of bone thickness
No osteosynthesis plates required for fixation
Limitations
Increased thermal conductivity
Subsequent bending not possible
Subsequent trimming not possible
In six easy steps to your IPS Implants®
The first step to creating your IPS® Implant begins with the case generation in the IPS Gate® upload and communication portal into which the patient data and other case-related information is uploaded.
Following the created inquiry, the data are checked by an IPS® developer with regard to their quality.
On the assumption that the data are of high quality, he then starts preparing the case and creates a first three-dimensional model. Based on the potential information and wishes on case planning, which can be supplied in advance by the user, the IPS® developer prepares the case planning. Communication between the clinical user and the IPS® developer then commences via the chat module in the IPS Gate® (alternatively: E-mail). Together, the case planning and product designs are discussed, adapted, and if necessary, modified. This is either done via joint online web meetings or via markings by the surgeon.
When the user is finally satisfied with the case planning given in the 3D PDF or Case Report (PDF), he/she signs the written prescription to release the design for production. Simultaneously he/she receives the economic offer and confirms this by sending an official order. After that, the case is both technically and economically accepted and confirmed.
After manufacturing, the product is shipped in time to user via the fastest route.
Legal basis for IPS Implants®
According to the regulations of the MPG (Medical Device Act) §3 Sentence 8, a custom-made product is a medical device manufactured on prescription according to specific design specifications and which is intended for the exclusive use for a named patient. For this reason a separate inquiry is necessary in every case.
The written prescription is a release for the technical offer (design of the products). This is to be submitted in writing by the user at the same time as the required order for the economic offer if he/she agrees with the desired case planning.
Shipment is not permissible as a matter of principle without this mandatory regulatory document.
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