Abahlinzeki Besistimu Abaphezulu abayi-10 be-ACL Graft Fixation eNyakatho Afrika (2026)

Isingeniso

Ukwakhiwa kabusha kwe-anterior cruciate ligament kudinga ukulungiswa okuxhunyanisiwe, ukwakhiwa komhubhe, ukuxhunyelelwa nokulungiswa. Ngakho-ke umsabalalisi ohlola abahlinzeki kufanele abheke ngale kwentengo yenkinobho eyodwa yekhohlo noma isikulufu sokuphazanyiswa.

Ohlangothini lwezinsikazi, odokotela abahlinzayo bangase bakhethe inkinobho yekhorothi eguquguqukayo yeluphu noma iluphu egxilile. Ukulungiswa kwe-Tibial kungase kuhilele PEEK , isikulufu se-bioabsorbable, i-biocomposite noma i-metallic interference. Ezinye izinqubo zisebenzisa i-screw-and-sheath construct noma i-supplemental ligament staple. Ukulungiswa kwe-graft kudinga futhi izinsimbi ezizinikezele, amashubhu okulinganisa, iziqondiso, izintambo zokuqondisa, ama-reamer nama-sutures anamandla aphezulu.

Lo mhlahlandlela wango-2026 uqhathanisa abahlinzeki abayishumi besistimu yokuxhunyelelwa ye-ACL efanele eMorocco, Tunisia naseLibya. Ukuhlola kugxile ekuhlanganiseni okuphelele kwenqubo, ukucaciswa kokufakelwa, ukuhambisana kwamathuluzi, imibhalo yokulawula, inani elincane lama-oda kanye nokwesekwa kwabasabalalisi.

CZMEDITECH ibalwa kuqala ngoba yayo i-arthroscopy implants kanye nephothifoliyo yezinsimbi ihlanganisa izinkinobho ezilungisekayo nezingaguquki, PEEK izikulufu zokuphazamisa , a Isisekelo se-ligament kanye ne- Isethi yethuluzi lokwakha kabusha i-ACL/PCL.

Lona umhlahlandlela wokuthola usizo lokuhlela kunezinga elihloliwe lokwabelana ngemakethe. Ukufakwa akuqinisekisi ukubhaliswa, ukusatshalaliswa okugunyaziwe noma isitoko e-Morocco, Tunisia noma e-Libya.

Impendulo Esheshayo: Yibaphi Abahlinzeki Abanikeza I-ACL Graft Fixation Systems?

Abahlinzeki abayishumi abahloliwe kulo mhlahlandlela yilaba:

1. CZMEDITECH

2. I-Arthrex

3. USmith+Umshana

4. I-Stryker

5. I-Zimmer Biomet

6. I-DePuy Synthes Mitek

7. CONMED

8. I-Medacta

9. I-Biotek

10. SBM

CZMEDITECH ihlinzeka ngenhlanganisela efinyelelekayo yokulungiswa kwe-femoral, ukulungiswa kwe-tibial namathuluzi angasetshenziswa kabusha kubasabalalisi. Imikhiqizo yamazwe ngamazwe ngokuvamile ihlinzeka ngemfundo ebanzi yomtholampilo kanye nezinto eziningi zokufakelwa, kodwa amanani, ukufinyelela kwendawo kanye nokutholakala kwendawo kuyahlukahluka.

Ukuhlaziywa Kwemakethe Yokulungisa I-ACL yaseNyakatho Afrika

Idatha yomphakathi ehlukanisa ukuthengiswa kokulungiswa kokuxhunyelelwa kwe-ACL e-Morocco, Tunisia nase-Libya kusalokhu kunomkhawulo. Imibiko yezentengiselwano ivamise ukuhlanganisa izimila ze-ligament nemishini ye-arthroscopy, ama-braces, biologics, izifakelo zamahlombe kanye nemikhiqizo yokuvuselela.

Uhlolojikelele lwemboni lwango-2026 lulinganisela ukuthi ukufakwa kwemithi yezemidlalo emhlabeni wonke kanye nemakethe yezinsimbi kukhuphuke kusuka ku-USD 5.0 billion ngo-2018 kuya ku-USD 6.1 billion ngo-2024. Ibikezela ukuthi imakethe ingafinyelela ku-USD 8.8 billion ngo-2030, okumele ukukhula konyaka cishe okungama-6.2% ukusuka ku-2024 kuya ku-2030 futhi Lezi zibalo zase-Afrika akufanele zethulwe njengezibalo zomhlaba wonke. Amanani emakethe aqondene ne-ACL.

Idatha yeBhange Lomhlaba ibeka inani labantu base-Morocco bango-2024 cishe ezigidini ezingama-38.1 kanye nelaseTunisia cishe ezigidini eziyi-12.3. Idatha yabantu iyodwa ayilinganisi isidingo sokufakelwa kwe-ACL, kodwa isiza abasabalalisi baqonde isilinganiso esihlobene samanethiwekhi ezibhedlela angaba khona.

Abashayeli bemakethe

Abashayeli bezidingo abangaba khona zifaka:

• Ibhola kanye neminye imidlalo ezungezayo

• Ukukhula kwezibhedlela zamathambo ezizimele

• Ukutholakala okubanzi kwe-MRI

• Odokotela abahlinzayo abengeziwe abaqeqeshelwe i-arthroscopy

• Ukulimala komgwaqo nokulimala kwamadolo emsebenzini

• Intshisekelo ekwakhiweni kabusha okungangeneleli kancane

• Ukuthuthukiswa kwemitholampilo yemithi yezemidlalo

• Isidingo sasesibhedlela samaphakheji ezinqubo eziphelele

• Isidingo sezinye izindlela ezithengekayo zamasistimu e-premium

• Ukunwetshwa kokusabalalisa kwedivayisi yezokwelapha kwasendaweni

I-Morocco

I-Morocco inesibalo esikhulu sabantu abaningi futhi ingelinye lamanethiwekhi ezibhedlela ezibanzi phakathi kwezimakethe ezintathu okuhlosiwe. Amathuba angase agxile eCasablanca, Rabat, Marrakech, Tangier nakwezinye izikhungo zasemadolobheni.

NgoMashi 2026, i-Moroccan Agency for Medicines and Health Products yamemezela ukuqinisekiswa kokubhaliswa kwamadivayisi ezokwelapha angama-660 emhlanganweni kazwelonke wekhomishini yokubonisana. Lesi sibalo sifaka izigaba eziningi zedivayisi yezokwelapha futhi asimeleli izimila ze-ACL, kodwa sibonisa ukucubungula okusebenzayo kokulawula.

I-Tunisia

I-Tunisia inendawo yokusabalalisa emtholampilo neyokwelashwa, enesidingo esigxile eTunis, Sfax, Sousse nakwamanye amadolobha amakhulu. Izinto zobuchwepheshe zaseFrance zingabaluleka ngokukhethekile ekubhaliseni, ekuqeqesheni ukuthengisa kanye nokuxhumana esibhedlela.

I-Directorate of Pharmacy and Medicines yase-Tunisia ishicilela izinqubo kanye nohlu lokuhlola lwedosi yezobuchwepheshe yemishini yezokwelapha engaphansi kolawulo lobuchwepheshe lapho ithengwa kwamanye amazwe.

I-Libya

I-Libya iveza amathuba ngokuthenga komphakathi, izikhungo ezizimele kanye nabangenisa impahla ngaphandle abaqeqeshiwe basendaweni, kodwa ukuhlelwa kwezinto kanye nokuxhumana nokulawula kudinga ukuhlela ngokucophelela.

I-General Authority for Medical Equipment, Supplies and Devices ithi izinkampani kufanele ziqedele ukubhaliswa kwabahlinzeki kanye nokuthi imikhiqizo ihlolwe ngobuchwepheshe ngaphambi kokungenisa noma ukukhululwa emakethe. Futhi ihlinzeka ngezinqubo zokugunyaza ama-ejenti nabasabalalisi.

Isibikezelo Sesidingo Esinokwethenjelwa Kakhudlwana

Abasabalalisi kufanele balinganisele isidingo esivela ezibhedlela ezikhonjwayo nodokotela abahlinzayo:

Izibhedlela eziqondiwe × amakesi e-ACL onyaka × izimila ngekesi ngalinye × izinga lokuguqulwa langempela

Hlukanisa isibalo ngokuthi:

• I-ACL iqhathaniswa nokwakhiwa kabusha kwe-multiligament

• I-Autograft iqhathaniswa ne-allograft

• Okuncanyelwayo kokulungiswa kwe-Femoral

• Okuthandwayo kokulungiswa kwe-Tibial

• Isikulufu impahla

• Isikulufu ububanzi nobude

• Ithenda yomphakathi iqhathaniswa nesibhedlela esizimele

• Ukuhlinzwa okuyisisekelo kuqhathaniswa nokubuyekezwa

• Amasethi wezinsimbi ezidingekayo

Lokhu kukhiqiza isibikezelo se-oda lokuvula esiwusizo kakhulu kunokusebenzisa iphesenti lemakethe yomhlaba wonke kubantu bendawo.

Ukuqonda i-ACL Graft Fixation

Ukulungiswa kokuxhunyelelwa kwe-ACL kufanele kubambe isixhumi ngenkathi ukufakwa kwezinto eziphilayo kuqhubeka. Isu lokulungisa elikhethiwe lincike ohlotsheni lokuxhunyelelwa, indlela yomhubhe, ikhwalithi yamathambo, okuthandwa ngudokotela ohlinzayo kanye nezinkomba zedivayisi ezigunyaziwe.

Izingxenye zenqubo yokwakhiwa kabusha kwe-ACL

Isistimu ephelele kufanele ihlonze ngokucacile izingxenye zayo ezisebenziseka kabusha nezilahlwayo. Izibhedlela kumele zazi ukuthi yimiphi imikhiqizo efakiwe, ethengwe ngokuhlukana noma edingwa amasu akhethiwe kuphela.

I-Fixed-Loop vs Adjustable-Loop Cortical Buttons

Izinkinobho ze-Cortical zinikeza ukulungiswa okulengayo ngokuhlala ngokumelene ne-cortex yangaphandle kuyilapho iluphu ixhuma igraft ku-implant.

Izinkinobho ze-loop ezilungisekayo

Iluphu elungisekayo ivumela ubude beluphu ukuthi bushintshwe ngesikhathi sesu eligunyaziwe lokufakelwa. Kungase kwenze kube lula ukusungula izinto ngoba umsabalalisi akadingi ukuba nesitoko njengobude obuningi obunqunywe kusengaphambili.

Abathengi kufanele baqhathanise:

• Ubude benkinobho, ububanzi nokuqina

• Iluphu impahla

• Ubude belophu yokuqala

• Ububanzi bokulungisa

• Indlela yokukhiya

• Ukudonsa kanye nokupheqa ama-sutures

• Indlela yokulayisha igraft

• Ukuhambisana komhubhe

• Ukulandelana kokuqina

• Ukupakishwa kokufakelwa

Izinkinobho ze-loop engaguquki

I-fixed-loop implant inikezwa ubude belophu enqunywe kusengaphambili. Inikeza umqondo wokulinganisa oqondile, kodwa ubude obuthile bungadingeka ekuhlanganiseni.

Udokotela ohlinzayo kufanele abale izidingo ze-tunnel ne-loop ngaphambi kokufakelwa. Ubude belophu obungekho bungabambezela inqubo ngisho noma umsabalalisi enabanye osayizi bezinkinobho esitokweni.

Iluphu engaguquki kanye nokuqhathaniswa kweluphu elungisekayo

CZMEDITECH 's Ikhasi lenkinobho yokulungisa ikhohlo ye-ACL libala kokubili ukulungiselelwa okulungisekayo kanye ne-fixed-loop.

Ububanzi beluphu engaguquki obushicilelwe buhlanganisa:

• 15 mm

• 20 mm

• 25 mm

• 30 mm

Abathengi kufanele baqinisekise amakhodi omkhiqizo wamanje, okokusebenza kweluphu kanye nokupakishwa okuyinyumba ngaphambi kokubhalisa.

PEEK vs Bioabsorbable Isikulufu se-interference s

Izikulufu zokugxambukela zivikela i-graft ngaphakathi komhubhe wamathambo ngokuminyanisa okulawulwayo.

PEEK izikulufu zokuphazamisa

I PEEK iyi-polymer ene-radiolucent, engeyona i-bioabsorbable. Ihlala itshaliwe futhi akufanele ichazwe ngokuthi iyamunceka.

Izinzuzo ezingaba khona zokuthenga zihlanganisa:

• I-artifact yesithombe yensimbi eyehlisiwe

• Ukwakhiwa kwe-polymer unomphela

• Izinketho eziningi zobubanzi nobude

• Ukulungiswa okusekelwe ngezikulufu okujwayelekile

• Ukuhambisana nokugeleza komsebenzi wokwakha kabusha okujwayelekile lapho kuqinisekisiwe

I- CZMEDITECH PEEK isikulufu sokuphazamisa sethulwe ukuze kwakhiwe kabusha i-ACL/PCL ye-arthroscopic kanye nokulungiswa kokuxhunyelelwa.

Ububanzi bayo bosayizi obushicilelwe buhlanganisa:

• 6 × 20 mm

• 6 × 25 mm

• 7 × 25 mm

• 7 × 30 mm

• 8 × 25 mm

• 8 × 30 mm

• 9 × 25 mm

• 9 × 30 mm

• 10 × 25 mm

Ikhasi liqukethe ukungqubuzana kwenkundla yezinto ezibonakalayo: ulwazi lwalo oluhlelekile luthi insimbi engagqwali yezokwelapha, kuyilapho isihloko nencazelo yomkhiqizo kukhomba izinga lezokwelapha PEEK . Abasabalalisi kufanele bathole ishidi ledatha lobuchwepheshe lamanje kanye nesimemezelo sempahla ngaphambi kokubhalisa noma ukuhanjiswa kwethenda.

Izikulufu ze-Bioabsorbable kanye ne-biocomposite

Izikulufu ze-Bioabsorbable zisebenzisa ama-polymers aklanyelwe ukwehlisa izinga ngokuhamba kwesikhathi. Izinhlobonhlobo ze-Biocomposite zingase zihlanganise ama-polymer awonakaliswa nezinto ezisekelwe ku-calcium.

Abathengi kufanele bahlole:

• Ukwakheka kwezinto ezibonakalayo

• Iphrofayili yokwehlisa isithunzi

• Impilo yeshelufu

• Izimo zokugcina

• Ukuzwela kokupakisha

• I-torque yokufaka

• Umklamo womshayeli

• Ukuhambisana kwe-Guidewire

• Ukubhaliswa kwendawo

• Izimangalo zebhayoloji ezigunyaziwe

Ikhasi lika CZMEDITECH eliqinisekisiwe elisesidlangalaleni limboza PEEK isikulufu. Inkampani akumele ichazwe njengehlinzeka ngesikulufu sokuphazamiseka esingaba khona ngaphandle uma ikhathalogi yamanje namadokhumenti aqondene nomkhiqizo kuqinisekisa lokho kulungiselelwa.

Ukuphazamiseka - ukuqhathanisa kwesikulufu

Ukulungiswa kwe-Screw-and-Sheath

Isistimu ye-screw-and-sheath ibeka i-sheath phakathi kwe-graft nesikulufu sokuphazamiseka. Kuye ngomklamo, i-sheath ingasiza ukuhlukanisa imicu yokuxhunyelelwa futhi isabalalise ukucindezelwa ngaphakathi komhubhe.

I CZMEDITECH Uhlelo lwe-arthroscopy ukubuka konke kuchaza PEEK umqondo wokulungisa isiphazamiso ngesheath, ukuthintana okungu-360-degree eduze kokuxhunyelelwa nezici ezimelene nokuxegiswa. Nokho, izinkomba eziqondile zomkhiqizo kanye nezimangalo ezigunyaziwe zamanje kufanele ziqinisekiswe ngaphambi kokushicilelwa noma uku-oda.

Abasabalalisi kufanele babuze:

• Ingabe i-sheath inikezwa ngesikulufu?

• Ingabe zombili izingxenye zenziwa kusukela ku PEEK ?

• Ikuphi ukucushwa kwegraft okusekelwayo?

• Yimaphi amasayizi wesikulufu nosayizi weshethi abhanqiwe?

• Ingabe i-dilator ethile iyadingeka?

• Iyiphi i-guidewire nomshayeli ehambisanayo?

• Ingabe ama-screw-with-sheath systems ahlukene ama-SKU?

• Ingabe i-IFU ichaza ukucushwa kwe-sheath?

Isikulufu esinesheath akufanele sithathwe njengesishintsheka ngesikulufa esivamile sokuphazamisa ngaphandle uma umkhiqizi ehlinzeka ngokuhambisana okubhaliwe.

I-staple ye-ligament is

Isisekelo se-ligament singahlinzeka ngokulungiswa okungeziwe ngokuya ngesu likadokotela ohlinzayo kanye nenkomba egunyaziwe yomkhiqizo.

CZMEDITECH 's okuyisisekelo kwe-ligament kukhonjwa njengemodeli C006. Incazelo yayo yasesidlangalaleni isho ukulungiswa kwe-autograft, i-allograft kanye nezingxenye zokufakelwa futhi ichaza ibhuloho eliyisicaba elinama-anti-back-out serrations.

Ikhasi liqukethe izitatimende zezinto ezingahambisani: inkambu yomkhiqizo wayo ohlelekile ibala insimbi yezokwelapha, kuyilapho i-athikili eshumekiwe ibhekisela ku-titanium. Isitifiketi samanje sempahla kanye ne-IFU kufanele kusetshenziswe esikhundleni sendatshana yokumaketha lapho kulungiswa imibhalo yokubhalisa.

Isisekelo se-ligament asidingeki kukho konke ukwakhiwa kabusha kwe-ACL. Kufanele kuchazwe njengenketho yokulungisa eyengeziwe esikhundleni sengxenye evamile yazo zonke izinqubo.

Ukulungiselela Ukuxhunyelelwa

Ikhwalithi yokufakelwa iyodwa ayikwazi ukunxephezela ama-graft angalungiswanga kahle. Umphakeli ophelele kufanele asekele ukuvunwa, ukulinganisa, ukuthunga kanye nokuqinisa ngaphambi kokuxhunyelelwa.

Isistimu yokulungiselela ukuxhunyelelwa ingase ihlanganise:

• Ibhodi lokulungiselela

• Ama-clamps alungisekayo

• I-tendon stripper

• Amashubhu okulinganisa ama-graft

• I-gauge yobude

• Ama-sutures aphezulu

• Suture passer

• I-tensioning mechanism

• Iziqondiso ze-Femoral kanye ne-tibial

• Guidewires

• Ama-reamers angasetshenzisiwe

• Izikulufa

• Ithreyi yokuvala inzalo

CZMEDITECH 's Isethi yethuluzi lokwakha kabusha i-ACL/PCL ifakwe kuhlu njengemodeli Y1000-10 futhi ichazwa ngokufakwa kohlu nokulungiselela umhubhe. Ikhasi lakhona elisesidlangalaleni libala i-MOQ yesethi eyodwa.

Abahlinzeki Besistimu Yokulungisa Okuphezulu kwe-ACL Graft

Ukuqhathaniswa komhlinzeki weMorocco, Tunisia kanye neLibya

1. CZMEDITECH

CZMEDITECH inikeza iphothifoliyo ehlanganisiwe yokufakelwa-ne-instrument kubasabalalisi abakha umugqa womkhiqizo wokwakha kabusha we-ACL.

Imikhiqizo yayo efanele ihlanganisa:

• Izinkinobho zekhorotiki ezilungisekayo

• Izinkinobho zekhorotiki ye-loop engashintshi

• PEEK izikulufu zokuphazamisa

• Umqondo wokulungisa ukuphazamiseka okusekelwe emgodleni

• Izimpawu ze-ligament

• Ama-sutures aphezulu

• Amathuluzi okwakha kabusha i-ACL/PCL

• Amathuluzi okulungisa umhume nomhubhe

• OEM kanye nosekelo lwe- ODM

Inzuzo eyinhloko ukuhlanganiswa kokuthengwa kwempahla. Umsabalalisi angaxoxa ngokulungiswa kwe-femoral, ukulungiswa kwe-tibial, ukulungiswa okungeziwe kanye namathuluzi angasetshenziswa kabusha nomphakeli oyedwa.

Ikhasi le- CZMEDITECH elisesidlangalaleni PEEK lifaka kuhlu i-MOQ yocezu olulodwa, futhi ikhasi lalo lensimbi ye-ACL/PCL libala i-MOQ yesethi eyodwa. I-oda lokuvula elixubile lingase livale ubude bezinkinobho eziningi nosayizi bezikulufu, kuncike ekhotheshini.

Ngaphambi koku-oda, abasabalalisi kufanele bacele:

• Ikhathalogi yomkhiqizo yamanje

• Ikhodi yomkhiqizo kanye nosayizi we-matrix

• Izimemezelo ezibonakalayo

• Ukuqinisekisa ukuvala inzalo

• Amadokhumenti empilo yeshelufu

• I-French IFU namalebula lapho kudingeka khona

• Ithebula le-Implant–instrument elihambisanayo

• Gcwalisa uhlu lokusethwa kwezinsimbi

• Isimemezelo sokuvumelana

• Izitifiketi zamanje zekhwalithi

• OEM ukuba nokwenzeka

• Isikhathi sokuhola sokukhiqiza

• Ubuncane bempilo yeshelufu esele

• Ngemuva kokuthengisa kanye nenqubo yesikhalazo

2. I-Arthrex

I-Arthrex inikeza enye yezindawo ezibanzi kakhulu zokwakha kabusha i-ACL emhlabeni jikelele. Iphothifoliyo yayo ihlanganisa ukulungiswa kwe-femoral okuguquguqukayo kanye ne-fixed-loop, izinto ezimbalwa zokuphazamisa-isikulufa, ama-sutures kanye nezinhlelo eziphelele zokulungiselela ukuxhunyelelwa.

Amandla ayo amakhulu ukuhlanganiswa kwezinqubo, ukutshala okuhlukahlukene kanye nemfundo yodokotela abahlinzayo. Ukucatshangelwa komsabalalisi kufaka phakathi intengo ye-premium, amalungiselelo endawo kanye nokugcina i-inventory enkulu yokufakelwa.

3. USmith+Umshana

USmith+Nephew unikeza ukulungiswa kwe-femoral suspensory, izikulufu zokuphazanyiswa kwe-tibial, ama-sutures namathuluzi okwakha kabusha. Iphothifoliyo yayo ihlanganisa izinto eziyisikulufa ezihlukene kanye nemikhiqizo eqondene nenqubo ethile.

Umkhiqizo ungafanelana nezikhungo ze-arthroscopy ezisunguliwe ezifuna ukwesekwa okuhlelekile kwezobuchwepheshe. Abathengi kufanele baqinisekise ukubhaliswa kwamanje kanye nokutholakala kwendawo e-Morocco, Tunisia nase-Libya.

4. Stryker

I-Stryker inikeza izimila namathuluzi okwakhiwa kabusha kwe-ligament, okuhlanganisa ukulungiswa kwe-femoral okulungisekayo kanye nezinhlelo zokuphazanyiswa kwe-tibial.

Izibhedlela ezisebenzisa imishini ye-Stryker arthroscopy zingakwazisa ubudlelwano bokuthenga obuhlanganisiwe. Abasabalalisi kufanele abale isamba sezindleko zenqubo, okuhlanganisa imikhiqizo elahlwayo, amathuluzi nokuqeqeshwa.

5. I-Zimmer Biomet

I-Zimmer Biomet inikeza ukulungiswa kwe-ACL ngaphakathi komuthi wezemidlalo obanzi kanye nephothifoliyo yamathambo. Amasistimu ayo angafaka ukulungiswa kwe-cortical, ukulungiswa kokuphazamiseka, ukulungiswa kwe-graft kanye nezinsimbi zomhubhe.

Ukuba khona kwayo okuqinisekisiwe kwezifo zamathambo kungase kusize ukufinyelela esibhedlela, kodwa ukutholakala komkhiqizo nezinhlelo zomsabalalisi wendawo zidinga ukuqinisekiswa.

6. I-DePuy Synthes Mitek

I-DePuy Synthes I-Mitek inikeza izimila zemithi yezemidlalo, ama-sutures anamandla aphezulu namathuluzi okwakha kabusha i-ACL. Imikhiqizo etholakalayo ingabandakanya ukulungiswa kwe-femoral suspensory kanye ne PEEK noma izikulufu zokuphazanyiswa kwe-biocomposite.

Imibhalo yenkampani yamazwe ngamazwe ingasekela amaqembu okuthenga, kodwa abathengi kufanele bacele ikhathalogi esebenza ezweni ngalinye eliqondiwe.

7. CONMED

I-CONMED ihlanganisa ukulungiswa kwe-ligament nephothifoliyo ye-arthroscopy ebanzi. Ububanzi balo bungabandakanya izinkinobho ze-cortical ezilungisekayo, izikulufu zokuphazanyiswa, ama-sutures namathuluzi okwakha kabusha.

Lokhu kungase kuhambisane nezibhedlela ezikhetha ukunciphisa inani labathengisi be-arthroscopy. Ukuhambisana kusafanele kuqinisekiswe ezingeni lekhodi yomkhiqizo.

8. Medacta

I-Medacta ihlinzeka ngezinhlelo zemithi yamathambo neyezemidlalo ngemikhiqizo yokulungisa izinsikazi nezinsikazi ezimakethe ezisebenzayo.

Ingacatshangwa ngabasabalalisi abafuna ubambiswano olubanzi lwamathambo. Ukucushwa komkhiqizo okuqondile, ukubhaliswa kanye nokusekelwa kokuqeqeshwa kwendawo kufanele kuqinisekiswe.

9. Biotek

I-Biotek inikeza izinkinobho zokulungisa i-cortical, izikulufu zokuphazanyiswa namathuluzi okwakha kabusha imisipha. Ingase inikeze enye indlela egxile ezindlekweni yabasabalalisi.

Abathengi kufanele bahlole ukuqinisekiswa, ukuvala inzalo, imibhalo yezobuchwepheshe, ukumbozwa kosayizi, ukushintshwa kwezinsimbi nokuthembeka kokulethwa.

10. SBM

I-SBM igxile kakhulu kuma-biomaterials emithi yezemidlalo kanye nokulungiswa kwe-ligament. Ubuchwepheshe bayo be-interference-screw bungasebenza kubathengi abafuna izinketho ze-bioabsorbable noma eziyinhlanganisela.

Abasabalalisi kufanele banqume ukuthi ingabe uhlelo oluphelele lwe-femoral-and-tibial luyatholakala yini noma ukuthi imikhiqizo ye-SBM kufanele ibhangqwe yini nenkinobho ye-cortical yenye inkampani namathuluzi.

CZMEDITECH Isixazululo Somkhiqizo

Kunconyiwe CZMEDITECH Iphakheji yenqubo ye-ACL

Iphakheji yokuvula kufanele ibonise isidingo sangempela sikadokotela ohlinzayo. Ukugcina yonke i-screw diameter nobude benkinobho ngaphambi kokukhomba abasebenzisi kungase kudale uhlu lwamagama olungadingekile.

Umhlahlandlela Wokuthenga

1. Qinisekisa indlela yokuxhunyelelwa ekhethwayo

Buza odokotela abahlinzayo ukuthi bayayisebenzisa yini i-hamstring, i-quadriceps noma i-bone-tendon-bone grafts. I-graft ithinta ukulungiswa, ubukhulu bomhubhe nokulungiswa.

2. Qhathanisa izindleko zenqubo ephelele

Bandakanya inkinobho ye-cortical, isikulufu sokuphazamiseka, ama-sutures, izisetshenziswa ezilahlwayo namathuluzi asebenziseka kabusha. Intengo ephansi yokufakelwa ingase ifihle izindleko ezengeziwe zensimbi.

3. Dala i-matrix yokuhambelana kokufakelwa

Xhuma yonke inkinobho nesikulufu ku-loop yayo, i-guidewire, umshayeli, i-reamer nesifaki. Unganciki kuphela kumbala wephakheji.

4. Qinisekisa izinto zokwakha

Cela izimemezelo eziqondene nomkhiqizo wezinkinobho, amalophu, izikulufu nezisekelo. Xazulula ukungqubuzana kwewebhusayithi ngaphambi kokuthunyelwa kokulawula.

5. Buyekeza amaphakheji oyinyumba

Qinisekisa indlela yokuvala inzalo, ukuqinisekiswa kwephakheji, usuku lokuphelelwa yisikhathi kanye nobuncane bempilo yeshelufu esele ekulethweni.

6. Cela i-oda lokuvula elixubile

I-oda elixubile lenkinobho evame ukucelwa nosayizi bezikulufu liwusizo kakhulu kunenani elikhulu lokucushwa okukodwa.

7. Lungiselela imibhalo yesiFulentshi

Ikhathalogi yesiFulentshi, amalebula, ama-IFU kanye nezinto zokuqeqesha zingasekela i-Morocco ne-Tunisia. I-Libya ingase idinge isi-Arabhu noma imibhalo eyengeziwe eqondene nezwe elithile.

8. Qinisekisa ubunikazi bokubhalisa

Inkontileka yokusabalalisa kufanele ikhombe ukuthi ubani umnikazi wokubhaliswa kwendawo nokuthi kwenzekani kuyo uma ubudlelwano bezentengiso buphela.

9. Hlela ukuqeqeshwa

Ukuqeqeshwa kufanele kufake ukulungiswa kokuxhunyelelwa, ukwakhiwa komhubhe, ukuthunyelwa kwezinkinobho, ukuqinisa iluphu kanye nokufakwa kwezikulufu ngokuya nge-IFU egunyaziwe.

10. Chaza izibopho zangemuva kwemakethe

Umkhiqizi nomsabalalisi kufanele bavumelane ngokulandeleka, izikhalazo, izehlakalo ezimbi, izenzo zenkundla kanye nokukhumbula.

Ukucatshangelwa Kokulawula

I-Morocco

I-Morocco ilawula imishini yezokwelapha ngaphansi koMthetho No. 84-12 kanye nohlaka lwawo lokusebenzisa. Ulwazi lokubhalisa olusemthethweni lucela imibhalo yokuphatha neyobuchwepheshe, okuhlanganisa isimo esisemthethweni somkhiqizo ezweni odabuka kulo kanye nolwazi lokupakishwa nokulebula.

I-Tunisia

I-DPM yase-Tunisia inikeza izinqubo zokulawula ubuchwepheshe kanye nezinhla zokuhlola zamadokhumenti emishini yezokwelapha engenisiwe. Abangenisi kufanele baqinisekise umzila osebenzayo wokulawula ubuchwepheshe kanye nokugunyazwa ngaphambi kokuthunyelwa.

I-Libya

I-General Authority yase-Libya Yezisetshenziswa Zezokwelapha, Izimpahla kanye Namadivayisi inikeza ukubhaliswa kwabahlinzeki, ukuhlolwa komkhiqizo, izimvume zokungenisa ezweni kanye nokugunyazwa kwama-ejenti agunyaziwe.

Izidingo zokulawula zingashintsha. Isiqiniseko esibhaliwe esivela kuziphathimandla ezinekhono kanye nomthengisi wasekhaya oqeqeshiwe kufanele kutholwe ngaphambi kokuhlinzekwa ngokuhweba.

Isiphetho

Abasabalalisi baseNyakatho Afrika kufanele baqhathanise abahlinzeki be-ACL njengozakwethu benqubo abaphelele. Izinkinobho ze-Femoral, izikulufu ze-tibial, amasistimu we-sheath, ama-staples, ama-sutures namathuluzi okulungiselela ama-graft kufanele ahambisane ngokobuchwepheshe futhi asekelwe imibhalo efanele.

I CZMEDITECH inikeza iphakheji efanelekile yokuhlonza izinkinobho ezilungisekayo nezingaguquki, PEEK izikulufu zokuphazamisa , a isisekelo se-ligament kanye nezinsimbi zokwakha kabusha ezisebenziseka kabusha. Iphothifoliyo yayo ephelele yokwakhiwa kabusha kwe-ACL ingasiza abasabalalisi ukuthi banikeze usizo ezibhedlela zaseMorocco, Tunisia naseLibya ngobudlelwano obuhlanganisiwe bokuhlinzeka.

Ngaphambi koku-oda, qinisekisa ukucaciswa kwamanje, izinto zokwakha, amathuluzi ahambisanayo, ubunyumba, impilo yeshalofu, amadokhumenti okubhalisa, i-MOQ, isikhathi sokukhiqiza kanye nokutholakala kwezinga lezwe.

imibuzo ejwayelekile ukubuzwa

1. Iyini i-ACL graft fixation system?

Kuyisethi ehlanganisiwe yezigxivizo namathuluzi asetshenziselwa ukulungisa, ukudlulisa nokuvikela ukuxhunyelelwa phakathi nokwakhiwa kabusha kwe-ACL.

2. Uyini umehluko phakathi kwezinkinobho ze-cortical ezingaguquki nezilungisekayo?

Inkinobho yeluphu engaguquki inobude obunqunywe kusengaphambili. Inkinobho ye-loop elungisekayo ivumela ukuguqulwa kobude beluphu ngokuya ngesu layo eligunyaziwe.

3. Ingabe inkinobho ye-loop elungisekayo ifanele konke ukwakhiwa kabusha kwe-ACL?

Cha. Ukukhethwa kuncike ohlotsheni lokuxhunyelelwa, indlela yomhubhe, i-anatomy, okuthandwa ngudokotela ohlinzayo kanye nenkomba egunyaziwe yedivayisi.

4. Ingabe i PEEK iyinto emuncayo?

Cha. PEEK i-polymer engunaphakade, engeyona i-bioabsorbable.

5. Ingabe i CZMEDITECH inikeza isikulufu sokuphazamiseka esingaba yi-bioabsorbable?

Ikhasi lomkhiqizo womphakathi eliqinisekisiwe limboza isikulufu PEEK . Ukutholakala kwemodeli ye-bioabsorbable kufanele kuqinisekiswe ngekhathalogi yamanje kanye nemibhalo eqondene nomkhiqizo.

6. Iyini isistimu yokulungisa isikulufu ne-sheath?

Isebenzisa i-sheath phakathi kwe-graft nesikulufu ukuze ihlele i-graft futhi isabalalise ukulungiswa ngaphakathi komhubhe. Imiklamo iyahlukahluka ngomkhiqizi.

7. Kungani kungase kudingeke i-staple ye-ligament?

Isisekelo se-ligament singanikeza ukulungiswa okungeziwe uma kusekelwa inqubo ekhethiwe kanye nenkomba egunyaziwe. Akuphoqelekile kuyo yonke inqubo ye-ACL.

8. Luhlanganisani uhlelo lokulungiselela ukuxhunyelelwa?

Kungase kuhlanganise ibhodi lokulungiselela, ama-clamps, amashubhu okulinganisa, ama-tendon strippers, amathuluzi okulinganisa kanye nama-sutures anamandla aphezulu.

9. Iyiphi i-MOQ CZMEDITECH eshicilelayo?

Ikhethiwe CZMEDITECH amakhasi aklelisa i-MOQ yocezu olulodwa lwe PEEK isikulufu sokuphazamiseka kanye nesethi eyodwa ye Isethi yensimbi ye-ACL/PCL . I-MOQ yokugcina incike ekhotheshini.

10. Ingabe imikhiqizo efanayo ingathengiswa eMorocco, Tunisia naseLibya?

Hhayi ngokuzenzakalelayo. Ukubhaliswa, ukulebula, ukugunyazwa kongenisa impahla kanye nokuba khona kufanele kuqinisekiswe ngokwehlukana ezweni ngalinye.

Umshwana wokuzikhipha emthwalweni wezokwelapha nomthetho: Ukubhaliswa komkhiqizo, izinkomba ezigunyaziwe, imininingwane kanye nokutholakala kwezentengiso kuyahlukahluka ngezwe. Lesi sihloko senzelwe ochwepheshe bezokunakekelwa kwempilo, amathimba okuthengwa kwempahla yezokwelapha nabasabalalisi abagunyaziwe. Ihlinzeka ngolwazi olujwayelekile lokuthenga futhi ayihlanganisi iseluleko sezokwelapha, iziyalezo zokuhlinzwa noma esikhundleni semiyalelo yamanje yokusetshenziswa komkhiqizi.