CE - FDA Certified
Our products are approved by the FDA and CE.
Stating the high quality of our products.
Patented Products
The ULC cap of our screws is patented.
Safer Products
The locking system with our ULC Cap is safer for patients because it reduces drastically the loosening due to stress and movements of the patient.
Easy to Install
We make the life of medical doctors easier. This ULC cap is really easy to instal. Surgeons will never go back to older screws after using ours.
STANDARDS APPLIED TO OUR HIP SYSTEM
| No. | Regulation & Standard No., Name | |
| 1 | Council Directive 93/42/EEC as amended by 2007/47/EC concerning medical devices(05 Sep. 2007) | |
| 2 | EN ISO 13485:2012 | Medical devices — Quality management systems — Requirements for regulatory purposes |
| 3 | EN ISO 14971:2012 | Medical devices — Application of risk management to medical devices |
| 4 |
EN ISO 15223-1:2012 |
Symbols for use in the labeling of medical devices |
| 5 | EN 1041:2008 | Information supplied by the manufacturer of medical devices |
| 6 | EN ISO 10993-1: 2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| 7 | EN ISO 10993-3: 2009 | Biological evaluation of medical devices — Part 3:Tests for genotoxity,carcinogenicity and reproductive toxicity |
| 8 | EN ISO 10993-5:2009 | Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity |
| 9 | EN ISO 10993-6:2009 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation |
| EN ISO 10993-10:2009 | Biological evaluation of medical devices — Part 10:Tests for irritation and delayed-type hypersensitivity. | |
| 10 | EN ISO 10993-12:2009 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| 11 | EN ISO 10993-18:2009 | Biological evaluation of medical devices — Part 18: Chemical characterization of materials. |
| 12 | EN ISO 11137-1:2006 | Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| 13 | EN ISO 11137-2:2012 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| 14 | EN ISO 11607-1:2009 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| 15 | EN ISO 11737-1:2006 | Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products |
| 16 | EN ISO 11737-2:2009 | Sterilization of medical devices — Microbiological methods — Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| 17 | EN ISO 14155-1:2011 | Clinical investigation of medical devices for human subjects — Part 1: General requirements |
| 18 | EN ISO 14155-2:2011 | Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans |
| 19 | ISO 14242-1:2012 | Implants for surgery — Wear of total hip-joint prostheses — Part 1: Loading and displacement parameters for wear-testing machines and corresponding environmental conditions for test |
| 20 | ISO 14242-2:2000 | Implants for surgery — Wear of total hip-joint prostheses — Part 2: Methods of measurement |
| 21 | EN ISO 14630:2009 | Non-active surgical implants — General requirements |
| 22 | EN ISO 16061:2009 | Instrumentation for use in association with non-active surgical implants — General requirements |
| 23 | EN ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| 24 | EN ISO 21534:2009 | Non-active surgical implants — Joint replacement implants — Particular requirements |
| 25 | EN ISO 21535:2009 | Non-active surgical implants — Joint replacement implants-Specific requirements for hip-joint replacement implants |
| 26 | EN 1041:2008 | Information supplied by the manufacturer of medical devices |
| 27 | EN 556-1:2001 | Sterilization of medical devices — Requirements for medical devices to be designated ‘Sterile’ — Part 1: Requirements for terminally sterilized medical devices |
| 28 | EN 556-2:2003 | Sterilization of medical devices — Requirements for medical devices to be designated ‘Sterile’ — Part 2: Requirements for aseptically processed medical devices |
| 29 | ISO 7206-4:2010 | Implants for surgery — Partial and total hip joint prostheses — Part 4: Determination of endurance properties and performance of stemmed femoral components |
| 30 | ISO 7206-6:2010 | Implants for surgery — Partial and total hip joint prostheses — Part 6: Determination of endurance properties of head and neck region of stemmed femoral components |
| 31 | MEDDEV 2.4/1 rev.9(June 2010) | Classification of medical devices |
| 32 | MEDDEV 2.7/1 rev.3(Dec. 2009) | Clinical evaluation: Guide for manufacturers and notified bodies |
| 33 | MEDDEV 2.12/1 rev.6(Dec. 2009) | Guidelines on medical device vigilance system |
| 34 | MEDDEV 2.12/2(May 2004) | Clinical Evaluation – Post Market Clinical Follow-up |
| 35 | ASTM F1044 | Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings. |
| 36 | ASTM F1147 | Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings |
| 37 | ASTM F 1160d | Standard Test Method for Shear and Bending Fatigue Testing of Calcium Phosphate and Metallic Medical and Composite Calcium Phosphate/Metallic Coatings |
| 38 | ASTM F136-08e1 | Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) |
| 39 | ASTM F1820d | Standard Test Method for Determining the Axial Disassembly Force of a Modular Acetabular Device. |
| 40 | ASTM F1929 | Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration |
| 41 | ASTM F1980 | Standard Guide for Accelerated Aging of Sterile Medical Device Packages |
| 42 | ASTM F2003-02 | Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air. |
| 43 | ASTM F2009-2000 | Standard Test Method for Determining the Axial |
| 44 | ASTM F2102-01e1 | Standard Guide for Evaluating the Extent of Oxidation in Ultra-High-Molecular-Weight Polyethylene Fabricated Forms Intended for Surgical Implants. |
| 45 | ASTM F543 | Standard Specification and Test Methods for Metallic |
| 46 | ASTM F648 | Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
| 47 | ASTM F75 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Castings and Casting Alloy for Surgical Implants (UNS R30075) |
| 48 | ASTM F799 | Standard Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants (UNS R31537, R31538, R31539) |
| 49 | ASTM F88 | Standard Test Method for Seal Strength of Flexible Barrier Materials |
| 50 | ASTM F981-04(2010) | Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone |