Spinal Fixation Systems – Spine Implants

RD MEDICAL is dedicated to supply the best implants & instruments to the market and founded by mechanical and materials engineers who are experienced in designing and manufacturing fields, as well by the consultancy of clinical experts. Company serves as an OEM and takes part within biomedical industry with its innovative and high quality products. PRODORTH products are designed, manufactured and developed in our organization, the results of which are always appreciated by well-known surgeons.

PRODORTH began its journey with the principle of “Human First” and always proceed in this way.

Knowledge combined with technology and innovator approach

We respect the know-how and appreciate its value. Some of PRODORTH products are pending for patent.

We always see the great results of integrating advanced scientific methods to guarantee better health recovery experience.

About Us

Since the establishment of RD MEDICAL, communication and service quality have been significantly improved with distributors.

We always follow new approaches and develop advanced methods to accommodate our products with the top notch technologies of the field in order to guarantee the satisfaction and approval of surgeons. Therefore, research and development are major factors in our dynamic organization which requires our involvement in interdisciplinary studies. We also conducted meticulous researches to improve our products based on multiple experiences of attending surgical operations.

Our mission

Providing top notch detailed oriented products which contribute to the success of surgical operations and proved to be satisfactory to surgeons along with its effect on reducing the healing time of patients. We guarantee the continuity of the excellence of our products through working with a dynamic and experienced engineering team to satisfy the need of high-quality products and fast supply in the sector.

Our vision

We aim to provide our service to the worldwide medical sector and gain an international recognition of PRODORTH brand as one of the major surgical suppliers with the determination to enlarge our product line to accommodate the ever-rising need of the medical sector.

Quality Management

In our opinion, “A sustainable quality mentality” is the most critical fact for the permanency of a company. The main approach of RD MEDICAL is to maintain high quality products for the long run, an approach which aims at earning trust and building loyalty with our customers who we aim to serve for the long term.

All our manufacturing processes are followed up and managed in accordance with the medical device directive 93/42/EEC, ISO 13485:2016 and CE standards. At the same time, the transition to the 2017/745/EC Medical Device Regulation (MDR) is in progress.

Instead of using these certificates just as keys for trade, we prefer managing our business according the requirements of these systems. ISO 13485:2016 Quality Management System is efficiently adapted on the organization of RD MEDICAL and provides a 100% traceability from initial to final product.

Our main task with respect to Quality Management is ensuring a complete control in a reliable and continuous production quality with machining, polishing, washing, color anodizing and laser marking units within our organization.

Biomechanical and biocompatibility tests were performed in accordance with ASTM and ISO standards which are required to launch our products to the market reliably in addition, all Prodorth products are firstly used by our surgeons and only launched to market after the succesful clinical outcomes are obtained.

Any healthcare professional (e.g. surgeon using the products) who has a complaint or is dissatisfied with quality, identification, reliability, safety, efficacy and/or performance of Prodorth Systems, are responsible from informing either Prodorth or the distributor.

Simple Technigues, Sophisticated Solutions

We reflect the value of our brand to our products and we would like to see the doctors feel our effort of understanding and solving their problems.

High Quality and innovation are the first details you will notice about PRODORTH products.

R&D / Innovation

RD Medical has identified the problems during surgical operations and contacted surgeons on this issue. These feed-backs and internal discussions, analysis and wide researches provide new approaches which leads to new ideas.

Research and development, to guarantee the production of high quality products will be always the priority of RD Medical to which “R&D” initials were adopted.

There are patent pending products of PRODORTH such as “PLIF Cage with Screw”.

Product Specifications

Products & Raw materials

Material selection is one of the most important point for implants.

Titanium Alloy (Ti6Al4V-Grade 5 / ISO 5832-3 / ASTM F136) and PEEK (Polyether-ether-kethon / ASTM F2026) are used as raw materials for all PRODORTH products and these are all originated from EU and USA. Both material are biocompatible and adequate for long term use

(C = Permanent (> 30 days)).

PEEK material is a remarkable raw material with its unique properties;

•Biocompatible

•It does not cause any lesional problems.

•Has elastical and hardness features near to bone tissue.•Titanium alloy materials give an opaque image under X-Ray, besides PEEK materials is able to be viewed transparently. This provides a more efficient follow-up for the bone fusion through the implant material at post-operative duration

SPINE DEVICES – SPINE IMPLANTS

POSTERIOR FIXATION SYSTEMS

Thoracolumbar Pedicle Screws

· Prodorth Pedicle Screws have a unique design with V-Shaped highly sharp threads, as well as a polished surface which results in succesful clinical outcomes.

· As it's proven so far, there is a direct relationship between the profile and the design of the pedicle screws with the pull-out strength, hence a strict quality control process is performed on the threads during the production.

· Stronger connection with head part by milled surface feature.

· More reliable tightening with the torx design of setscrew. Reverse angled setscrew thread design.

· Easy initiative insertion.

· Mono threaded and double threaded options are availabe on request. Double threaded Pedicle Screws have been designed for reducing the number of turns required for a complete implantation which reduce the operation time in result.

· Titanium / Ti6Al4V (ASTM F 136) is used as raw materials for all PRODORTH pedicle screws and these are all originated only from reliable partners in USA.

Prodorth Posterior Fixation System is used for stabilizing the disorders in spine. The system is composed of different type of pedicle screws, rods, connectors and some other supplementary elements.

This system is completely manufactured from Ti6Al4V (ISO 5832-3) material. (Except the PEEK rods which are made of PEEK material/ASTM F2026)

PRODORTH Posterior Fixation System has been used since 2013 in domestic market (Turkey), 2014 in EU countries, and Asia-Pacific region and since 2015 in South America and Middle-East. We continue our journey by expanding in new markets with an increasing satisfaction from the surgeons.

Within recent years, the system has been developed and revised according to feed-backs from surgeons and customers, which led to establishing a reliable system that corresponds to the scientific requirements and the finest technical details demanded by surgeons.

Mechanism of Action for Prodorth Posterior Fixation Implant System is implantation of the system into the vertebras and connection with rods and transverse connectors which generates an efficient support to spine by a rigid construction in order to provide stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and chronic instabilities or deformities of the cervical, thoracic, lumbar, and sacral spine.

In other words, it provides stabilization to promote fusion following reduction of fracture/dislocation or trauma in the spinal junction and the spine.

INSTRUMENTS PROPERTIES

· Made of special stainless steel raw material with ultra high corrosion resistance and silicone appropriate for medical applications.

· Besides the high corrosion resistance, they are also appropriate for all kind of sterilization types including steam sterilization at high temperatures. (Up to 137° degree)

· Critical instruments such as screw drivers, nut drivers are offered double pieces in the container in case of any failure or falling on the floor. Hence the surgeon will be able to continue surgery without wasting time.

· Special designed rod cutters provides less burrs and easier cutting are available on request.

· Entire items of Prodorth Instrumentation are CE certified.

· We offer a completely suitable instruments for degenerative, as well as deformity cases. It's possible to add or exclude the required instruments according to our customers' needs.

ROD & CONNECTORS

Linear & Multiaxial

PRODORTH Connectors have been designed to provide the most stable construction with different sizes.

We offer mainly two types of connectors as “Linear Connectors” and “Multiaxial Connectors” as well as various designs considering the needs of our clients.

PLIF PEEK CAGES

Regular PLIF - Expandable PLIF - PLIF with Screw

Standard and Expandable types besides various sizes are available

· Made of PEEK (ASTM F2026) which is a polymer based composite material and Ti6Al4V (ASTM F 136) materials.

· Holding inferior and superior areas strongly with appropriate surface design.

· X-Ray Markers for easy visualization during implantation.

· Toothed surface design to prevent migration

· Easy to implant with sharp ended design.

· Stopping system during expansion.

· Sufficient space for fusion.

· Anatomical geometry

PLIF PEEK CAGE with THREAD

· PEEK material (ASTM F2026) and Titanium (ASTM F 136) is combined through the creation journey of ProMole. As it’s accepted by health authorities, PEEK does not cause any lesional problems in addition its elasticity and hardness features are quite near to bone tissue.

· Since ProMole has the titanium threads on the tip and the marker pins behind, surgeon can follow ProMole during surgery very efficiently.

· ProMole can be connected with its instruments very easily .

· Once the internal appratus of its inserter placed through the inserter, it can rotate the thread at the front.

· When the thread is rotated clockwise, ProMole will be pulling itself into the intervertebral area. Likewise it is able to be unscrewed by rotating the thread anticlockwise. These specifications of it provides a more reliable and easy implantation considering the traditional PLIF procedure

· PROMOLE® Cages provides a gradually placement.

· Toothed surface feature for best-holding the inferior and superior areas.

· PEEK material is originated from EVONIK Industries Germany.

· X-ray marker pins for the visibility.

· Various sizes are available on request.

TLIF PEEK CAGE

Rotatable Design

Prodorth TLIF Cage is intended for single use only and restore the degenerative disc pathologies.

Prodorth TLIF Cage is made of PEEK (ASTM F2026) which is a polymer based composite material and Ti6Al4V (ASTM F 136) material.

· PRODORTH Tlif Cages ® provides an uninterrupted guidance during operation.

· Circular toothed surface feature for a better holding on the inferior and superior areas.

· It has the capability of movement to both directions.

· It can be fixed by rotating the wheel behind Inserter, and it is easily released by loosening.

· This provides an easy positioning as required.

· After discectomy, the wheel is rotated clockwise while the TLIF cage is positioned upright and it’s placed into intervertebral area so on.

· After that the wheel is loosened and the ProDolphin is released as at the required position.

· All the procedure is performed by a single instrument.

CERVICAL DISC PROSTHESIS

One Piece Design

· Completely made of titanium and PEEK.

· PEEK material at the inner mechanism, provides a super-smooth surface for a perfect motion capability.

· PEEK cover which is shaped as a tube, has been positioned around the inner mechanism in order to prevent the bone-fusion through the inside of disc prosthesis.

· One-piece design.

· Dark anodized and rough surface options are available

· Physical capability of Flexion Extension - Lateral Bending – Rotation. Minimizing the scratching by the coating.

· Special design for the most effective movement ability

· Reliable construction for best-holding on endplates.

· Reliable and stable connection with the instrument. Appropriate for Smith-Robinson approach.

· Ti6Al4V (Grade 5) is used as raw materials for all PRODORTH disc prosthesis and these are all originated only from reliable partners in USA. PEEK material is supplied from EVONIK INDUSTRIES Germany. All certificates are available on request.

PRODORTH Cervical Disc Prosthesis is an implantation system used for eleminating the complaints of the patients which rise from the herniation at discs, traumas or any disorders on cervical spine.

PROCORAL V.2 is composed of 2 plates working separately and connected each other by a kind of a particular pin, besides a special designed PEEK system is used at the inner mechanism to obtain a more efficient movement capability.

Using ProCoral V.2 cervical disc prosthesis instead of traditional fusion cages minimize the Heterotopic Ossification, with its capability to make motions to various directions and in result it has more similar specifications to an healthy disc.

ProCoral V.2 is designed as Metal - PEEK - Metal (M-P-M) construction with various sizes and footprints. One piece design of it, provides an easier surgical tecnique as well as the great fixation with its inserter. Furthermore its wear resistance is pretty higher than competitors with its M-P-M design and for long-term, better results have been obtained on post-operative period. The Prodorth’s top-notch technology “PEEK tube” cover around the inner mechanism prevent the undesired bone fusion into the disc prosthesis.

CERVICAL ARTIFICIAL DISC – TOTAL DISC REPLACEMENT

· Completely made of titanium and PEEK.

· PEEK material at the inner mechanism, provides a super-smooth surface for a perfect motion capability.

· PEEK cover which is shaped as a tube, has been positioned around the inner mechanism in order to prevent the bone-fusion through the inside of disc prosthesis.

· One-piece design.

· Dark anodized and rough surface options are available

· Physical capability of Flexion Extension - Lateral Bending – Rotation. Minimizing the scratching by the coating.

· Special design for the most effective movement ability

· Reliable construction for best-holding on endplates.

· Reliable and stable connection with the instrument. Appropriate for Smith-Robinson approach.

CERVICAL PEEK CAGES

PROYSTER®

Cervical Peek Cage provides a great fixation with its blade, which makes it a "Stand-Alone Interbody Cage" possible to be used without a plate.

One of the best advantage of Proyster® is offering a very simple application which is usally found pretty user-friendly by the surgeons.

Proyster® Peek Cage with mono / double blade options and regular cervical peek cages are available on request.

· Toothed surface is designed to prevent migration.

· Anatomical geometry.

· X-Ray Markers provide an easy placement.

· Made of PEEK material, originated from EVONIK Industries Germany. Titanium alloy materials give opaque image under X-Ray, however PEEK materials is able to be seen transparently. This provides efficient following of the bone fusion through the implant at the intended periods.

· Blades for a more reliable holding between the endplates.

· Maximum Strong Construction / Fusion Space ratio.

· Various sizes and footprints are available.

CERVICAL CAGES

· Toothed surface is designed to prevent migration.

· Anatomical geometry.

· X-Ray Markers provide an easy placement.

· Blades for a more reliable holding between the endplates.

· Maximum Strong Construction / Fusion Space ratio.

· Various sizes and footprints are available.

Distributorship

One of the initial goals of PRODORTH is supplying highest quality implants with the finest conditions to our customers. Therefore we pay a great attention to our products, a policy which stems from our belief that all people deserve to receive a topnotch health care.

Thus we always aim to provide an excellent service to our customers as we are keen to establish a long term relationship with them.

PRODORTH services are available in various locations worldwide. Agents and distributors' information is kept confidential with us. For further information please don't hesitate to contact us.

Our customer service will be happy to answer all your queries.

Distribution details;

* Distribution zone

* Discount rates

* Training with your staff and technical support

* Contents of our goods

* Distribution contract

Please contact us.

Source: spine company, spine device, pedicle screw

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