PyroDisk™ Interpositional CMC Implant
Choosing the Pyrocarbon Interpositional CMC implant helps you to limit uncertainty during your CMC replacement cases for young and demanding patients.
The PyroDisk™ CMC implant is a biarticular convex disc made of PyroCarbon,designed to resurface the thumb carpometacarpal (CMC) joint damaged by arthritis.The implant and CMC joint are stabilized by the flexor carpi radialis tendon, transferred and passed through the trapezium,through the implant, and into the first metacarpal.
Features & benefits
- Minimal bone resection which helps to preserve the trapezium.
- No Thumb shortening.
- Open pathway to revision.
Available in 6 sizes:
|Size||A. Disk Diameter||B. Disk Height|
After cyclical testing to 5,000,000 cycles, PyroCarbon demonstrated minimal wear into cortical bone*. The other materials exhibited extensive bone wear at 375,000 cycles with Cobalt Chrome, 50,000 – 75,000 cycles with Titanium and 25,000 cycles with Zirconia.¹
* Laboratory testing on bovine bone
PyroCarbon is Bone Friendly
The elastic modulus of PyroCarbon is similar to cortical bone resulting in biomechanical compatibility with bone. Unlike surgical grade metals, PyroCarbon transfers load from implant to bone more effectively, thus reducing stress shielding and potential bone resorption.²
The PyroDisk™ CMC implant is intended to replace the joint between the first metacarpal and the trapezium in cases of rheumatoid arthritis, traumatic arthritis,osteoarthritis or post fracture deformation or bone loss which present as either a painful, unstable thumb, or a thumb with limited range of motion.
- Inadequate bone stock or soft tissue coverage
- Previous open fracture or infection in the joint
- Skeletal immaturity
- Physical interference with or by other prostheses during implantation or use
- Procedures requiring modification of the prosthesis
- Skin, bone, circulatory and/or neurological deficiency at the implantationsite
Regulatory and Legal Information
class I and IIa and IIb devices.
Ascension Orthopedics, inc.
8700 Cameron road Suite 100
Austin, Texas 78754 • USA
Ascension Orthopedics Ltd.
Biopark, Broadwater Road
Walwyn Garden City
Herts, AL7 3AX • United Kingdom
Availability of these products might vary from a given country or region to another, as a result of speciﬁc local regulatory approval or clearance requirements for sale in such country or region.
• Consult product labels and inserts for any indications, contraindications, hazards, warnings, precautions and instructions for use.
• Non contractual document. Integra reserves the right, without prior notice, to modify the products in order to improve their quality.
• Warning: Applicable laws restrict these products to sale by or on the order of a physician.
Please contact Integra customer service should you need any additional information on devices classiﬁcation. All the medical devices mentioned on this document are CE marked according to European council directive 93/42/ EEC on medical devices and its relatives, unless speciﬁcally identiﬁed as “NOT CE MARKED”.
PyroDisk is a trademark of Integra LifeSciences Corporation or its subsidiaries in the USA and/or other countries. ©2016 Integra LifeSciences Corporation. All rights reserved.
Last modifcation date: 04/2016. 0491143-1-EN
Document for use in Europe, Middle-East & Africa only.
For complete product information, please see the Instructions for Use accompanying each product.