KLS Martin IPS Implants®

MODEL

IPS Implants®

HSN CODE

90185090

EAN UPC CODE

EAN - NA

Brand: KLS Martin India Pvt Ltd
Category: Individual Patient Solutions
 
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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