Kuyavuya ukwazisa ukuba uluhlu olupheleleyo lwemveliso yeZATH lufumene imvume ye-CE. Ezi mveliso ziquka:
1. I-prosthesis yesinqe esingenazintsholongwane - Udidi lwesiThathu
2. Isikrufu seThambo lesinyithi esingenazintsholongwane/esingenazintsholongwane - Udidi IIb
3. Inkqubo Yokulungisa Umqolo Ongenazintsholongwane/Ongenazintsholongwane - Udidi IIb
4. Inkqubo yePlati yokuKhiya engenazintsholongwane/engenazintsholongwane - Udidi IIb
5. Isikrufu Esingenazintsholongwane/esingenazintsholongwane - Udidi IIb
6. Ikheyiji yokudibanisa umzimba engenazintsholongwane/engenazintsholongwane - Udidi IIb
7. Isakhelo sokuLungiselela sangaphandle esingenazintsholongwane/esingenazintsholongwane (esinephini) - Udidi IIb,
Ukuvunywa kwe-CE kubonisa ukuba uluhlu olupheleleyo lwemveliso ye-ZATH luhambelana nemigangatho nemigaqo efanelekileyo ye-EU, kwaye luvula indlela yokungena kwimarike yaseYurophu nakwezinye iindawo zehlabathi.
Ipotifoliyo yemveliso evunyiweyo iqulethe i-ZATH trauma (ipleyiti yokutshixa, isikrufu sethambo, isikrufu esine-cannulated kunye ne-external fixators), umqolo (iinkqubo zokubopha ngaphakathi komqolo kunye ne-fusion) kunye neenkqubo zokutshintsha amalungu (ii-hip joint). Kwangaxeshanye, ukongeza kwiimveliso ezidibeneyo, iimveliso ze-ZATH trauma kunye ne-spinal spine nazo ziyafumaneka kwiipakethe ezicociweyo, ezingenakunciphisa kuphela izinga losulelo kwizigulane, kodwa zikwaphucula izinga lokujika kwezinto ezisetyenzisiweyo kumaqabane ethu abasasazi. Okwangoku, i-ZATH yeyona mveliso yodwa yamathambo ehlabathini ebonelela ngepakethe ecociweyo kuyo yonke imveliso yayo.
Ukuphumelela kube kanye kwesatifikethi se-CE kumgca opheleleyo wemveliso akubonisi nje kuphela amandla obuchwephesha aqinileyo e-ZATH kunye nomgangatho ogqwesileyo, kodwa kukwabeka isiseko esiqinileyo sokuthatha amanyathelo angakumbi kwimarike yamazwe ngamazwe.
Ngokuphuhliswa kweminyaka engaphezu kwe-10, i-ZATH iseke ubudlelwane bentsebenziswano kumazwe amaninzi avela kwimimandla yaseYurophu, e-Asia, e-Afrika naseLatin America. Kungakhathaliseki ukuba iimveliso zokwenzakala okanye zomqolo, okanye iimveliso zokutshintshwa kwamalungu, zonke iimveliso ze-ZATH zifumana ukuqatshelwa okuphezulu ngamaqabane ayo aphesheya kunye noogqirha botyando kwihlabathi liphela.
Ngokuvunywa kwe-CE, siza kusebenzisa eli thuba ukuqala uhambo olutsha kwicandelo le-orthopedic kwihlabathi liphela.
Ixesha lokuthumela: Agasti-29-2022