RegJoint™ is indicated for arthroplasties in small joints in hand and foot for patients suffering of rheumatoid arthritis or osteoarthritis. The specific target joints are metatarsal I-V, V (MTI I-V) in foot, carpometacarpal (CMC I) and metacarpophalangeal II-V (MCP II-V) joints in hand.
RegJoint™ is produced of bioabsorbable 96L/4D poly-L/D-lactide copolymer fibre. It is a round, porous, disc like implant. Diameter of the implant varies from 8.0 to 18.0 mm and thickness from 3.6 to 4.5 mm, sizes and reference numbers are in Table 2. The implant size in each case shall be as close to the joint size as possible. The scaffold allows bone grafting at the time of implantation and provides temporary support and guidance to soft tissue in-growth to allow a gradual optimized replacement of the implant with fibrous tissue, providing a flexible, but durable pseudojoint.
RegJoint™ loses its strength over 15 to 24 weeks in vivo, with complete strength loss and resorption within several years, depending on the patient variables. Installation of RegJoint™ implant does not require any specific instrumentation, but standard instrumentation including drills and surgical sutures are used. All surgical instruments need to be appropriately cleaned and sterilized before use in aseptic field in operation theatre. All surgical sutures and other materials need to be sterile.
RegJoint™ is sterilized by gamma irradiation and it is supplied sterile and ready for use in the operation. RegJoint™ must not be sterilized by any method by the user.
MED&CARE Sp. z o.o.
ul. Mławska 13
81-204 Gdynia, Poland
NIP 9581708968
REGON 386298925
phone: +48 58 776 22 75
fax: +48 58 350 97 57
mobile: +48 506 399 272
email: office@medandcare.pl
Number: PL 92 1020 1853 0000 9502 0124 1017
Bank PKO BP SA, I Oddział w Gdyni
Kod BIC (Swift): BPKOPLPW
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