Top 15 Umusumari wo mu musokoro w'amagufa Abakora muri Porutugali (2026 Igitabo cyamasoko)

Intangiriro

Isoko ryo kugura ibikoresho byubuvuzi murwego rwamagufwa ya Porutugali ririmo kwihuta kwiterambere. Bitewe na manda zikaze zitangwa na minisiteri yubuzima ( Ministério da Saúde ) hamwe n’umuvuduko mwinshi w’ihungabana ucungwa n’inzego z’ubuzima zaho ( Unidades Locais de Saúde - ULS ) munsi y’ikigo cy’igihugu cyita ku buzima ( Serviço Nacional de Saúde - SNS ) - hakurya y’amatsinda y’ibitaro byigenga nka Luz Saúde, CUF, na Lusíadas imikorere yubuvuzi, umutekano ugenga, hamwe ningengo yimishinga.

Mugihe ucunga amagufwa maremare, guhitamo neza imisumari (IM) umufatanyabikorwa ni ingenzi mukugabanya ibibazo nyuma yibikorwa no gucunga ibiciro byinzego munsi ya Concursos Públicos (Amasoko rusange) hamwe nubuyobozi bushinzwe kugura, SPMS ( Serviços Partilhados do Ministério da Saúde ). Aka gatabo kerekana Top 15 Umusumari wo mu musokoro w'amagufa Abakora ibicuruzwa muri Porutugali, bibanda ku nshingano zabo z’ibanze, kumenyekana ku isoko, hamwe n’ikoranabuhanga ry’ibanze kugira ngo bafashe injeniyeri y’ibinyabuzima, abaganga babaga amagufwa, n’abashinzwe gutanga amasoko mu gufata ibyemezo bishingiye ku makuru.

Kwagura Tekinike: Gusobanukirwa Byihariye Umusumari wo mu musokoro w'amagufa Ibishushanyo muburyo bwo guhahamuka bigezweho

Mu isuzumabumenyi ryuzuye ry’ubuvuzi hirya no hino mu bigo nderabuzima, amasoko y’ihungabana arasaba gusobanukirwa byimbitse tekinike yubukanishi bwatewe. Imisumari yimbere ntabwo ikiri inkoni rusange yicyuma; kubaga bigezweho bisaba ibinyabuzima byihariye bya biomehaniki bihuye nuburyo bwihariye bwo kuvunika hamwe na patologi y'abarwayi.

Gufasha inama zibitaro hamwe na komite zishinzwe kubaga koroshya inkomoko y’ihungabana, ni ngombwa kumva ibyiciro by’ibanze byihariye bya Imisumari yo mu musokoro w'amagufa byiganje mu makinamico ya ortopedie:

1. Guhuza Imisumari yo mu musokoro w'amagufa (Igikomeye na Cannulated)

Guhitamo hagati yimisumari ikomeye kandi yometseho bigira ingaruka zikomeye kubikorwa byo kubaga no gukiza amagufwa.

• Cannulated Imisumari yo mu musokoro w'amagufa  : Iyi misumari igaragara hagati yubusa, ibemerera kwinjizwa hejuru yicyuma kiyobora. Igishushanyo gifasha abaganga gukora insimburangingo yongeye kwaguka, yagura umuyoboro wa medullary, ituma umusumari munini, ukomeye, kandi ugashyira ibice byavunitse amagufwa byaho byacitse kugirango byihute gukira.

• Igikomeye Imisumari yo mu musokoro w'amagufa : Byakoreshejwe cyane cyane mubuhanga budatekerejweho, imisumari ikomeye ikunze gutoranywa mubice byavunitse bikabije cyangwa indwara ya polytrauma kugirango bigabanye ibyago byo kwanduza amavuta no kugabanya ihungabana ryamaraso ya endosteal.

2. Cephalomedullary Imisumari & Sisitemu Yumugore

Kuvunika kugaragara kumpera yegereye ya femur (akarere ka hip), imisumari isanzwe ihuza ntabwo ihagije. Sisitemu yihariye ya cephalomedullary irasabwa gukemura imitwaro ikabije ya physiologique.

• Kwiyubaka Gufunga Iboneza : Ibi bishushanyo biranga umwobo wihariye wo gukurikiranwa hafi ya dogere 130 kugeza 135, bigatuma imiyoboro iremereye cyane inyura mumisumari mu mutwe wigitsina gore, ikavunika ibice bya subtrochanteric cyangwa impande zombi.

• Anti-Rotation Helical Blade Sisitemu : Ikoreshwa cyane cyane mu kuvunika ikibuno cya geriatricique, sisitemu isimbuza imigozi gakondo ya lag hamwe nicyuma cyo kwikuramo. Igishushanyo kigabanya amagufwa akikije aho kuyakuraho, kugabanya cyane ibyago byo guterwa 'gukata ' mumagufwa ya osteoporotic.

3. Retrograde na Anterograde Imisumari miremire

Ukurikije aho wavunitse hamwe nubunyangamugayo bworoshye, abaganga bagomba guhitamo ibinyuranyo byinjira kugirango binjizwemo imisumari.

• Isoko rya Anterograde : Implants zinjijwe kuva kumpera yegeranye (urugero, kwinjira muri trochanter kugirango avunike femur). Ibi bisaba kunama neza imisumari kugirango ihuze na anatomical curvatures.

• Retrograde Sourcing : Implants zinjijwe kuva kumpera ya kure (urugero, kwinjira hejuru yikivi). Imisumari yihariye ya retrograde femorale igaragaramo uburyo bwihariye bwo gufunga uburyo bwo kurinda ibice bya gatatu bya supracondylar.

Inganda zikomeye ku isi & Ibirango biyoboye

1. Isosiyete ya Stryker

Umukinnyi wiganje mu miyoboro yigenga ya Porutugali no mu bigo byinshi by’ibitaro bya kaminuza, Stryker ukorera muri Amerika yubahwa cyane kubera ubuhanga bw’ubuhanga ndetse n’ubufasha bukomeye mu bucuruzi.

• Ibicuruzwa byibanze: Gusimburana hamwe, porogaramu ifashwa na robo (Mako), ibikoresho bya neurotechnology, hamwe na sisitemu yo gukosora ihahamuka.

• Core Portfolio: Sisitemu ya Gamma4 Trochanteric Nail Sisitemu na T2 Alpha Interlocking Nail Sisitemu itanga iterambere ryimashini hamwe nibikoresho byabigenewe.

2. DePuy Synthes (Johnson & Johnson MedTech)

Ufite imyanya yashinze imizi mu nzego za Leta (SNS) ndetse n’ibitaro byigenga muri Porutugali, DePuy Synthes ikoresha imyaka mirongo y’ubushakashatsi ku mavuriro bushyigikiwe na AO Foundation.

• Ibicuruzwa byibanze: Sisitemu ihungabana yuzuye, ibisubizo byubaka byubaka, ibikoresho bya craniomaxillofacial, hamwe na biomateriali yumugongo.

• Core Portfolio: Impuguke ya Nail Sisitemu na TFNA (Trochanteric Fixation Nail Advanced) bakoresha uburyo bwo kuvura ibyuma byateganijwe neza kugirango bavunike amagufwa maremare kandi maremare.

3. CZMEDITECH

Nka mbaraga zizwi kwisi yose mubikoresho byubuvuzi bwamagufwa, CZMEDITECH yashyizeho uburyo bwagutse bwo gutanga isoko ku isoko ry’Uburayi bw’Amajyepfo, harimo na Porutugali. Iyi sosiyete izwiho gukemura icyuho kiri hagati y’Ubudage bwo mu rwego rwo hejuru kandi ikora neza cyane mu gukora inganda, isosiyete itanga uburyo bw’ihungabana bwuzuye bufite ibyemezo mpuzamahanga by’ubuvuzi - harimo ISO CE , 13485

CZMEDITECH Imirongo yibanze yibicuruzwa

• Sisitemu yo guhahamuka ya orthopedic: Guhuza imbere Imisumari yo mu musokoro w'amagufa , Anatomical Gufunga Amasahani & Imiyoboro, na Sisitemu yo gukosora hanze.

• Gukemura Uruti rw'umugongo : Imbere / Inyuma ya Cervical & Thoracolumbar Sisitemu, Imirongo ya Fusion Fage, hamwe na Rods Fixation Rods.

• Cranio-Maxillofacial ( CMF ) Implants : Ultra-low profile ya Titanium Plate na Urushundura Sisitemu yo kwiyubaka mumaso.

• Ibikoresho byo kubaga ibikoresho & ibikoresho: Gukora cyane Imashini ibora amagufa s, Oscillating Saws, hamwe nibikoresho byo guhuza ibikoresho.

• Customized OEM/ODM Serivise : Gukora ibikoresho byubuvuzi birangira-byanyuma bikwiranye nibitaro byisi.

• Core IM Nail Portfolio & Ihuza:

  • Femorale Umusumari wo mu musokoro w'amagufa : Yakozwe kuva Titanium Alloy yo mu rwego rwo hejuru (Ti-6Al-4V ELI), igaragaramo uburyo bwiza bwo kugabanuka hamwe na planari nyinshi zifunga ibishushanyo kugirango bitange gukosorwa gukomeye kuvunika.

  • Umusumari wo mu musokoro w'amagufa Tibial

  • Umusumari wo mu musokoro w'amagufa Humeral

  • Antirotation ya Proximal Femoral Nail - PFNA : Ibiranga sisitemu ya pisitori ikozwe neza kubarwayi bakuze bafite amagufwa ya osteoporotique, bigatuma barwanya cyane gucibwa mugihe cyo kuvunika kwa trocanteric.

Zimmer Biomet Holdings, Inc.

Zimmer Biomet ihuza urubuga rwubuvuzi bwa digitale hamwe na tekinoroji yo gutunganya imitsi ya musculoskeletal, ikora imiyoboro minini yubuzima bwa metero nkuru muri Porutugali.

• Ibicuruzwa byibanze: Guhuza ibipimo byubuzima bwa digitale, gusimburana hamwe, ibyuma byimiti ya siporo, hamwe no guhahamuka.

• Core Portfolio: Sisitemu Kamere Kamere igaragaramo imiterere ya anatomicale yagenewe guhuza imiterere itandukanye y’abarwayi hirya no hino mu mibare y’uburayi bw’iburengerazuba.

5. Smith & Mwishywa plc

Hamwe nibikorwa bitaziguye hamwe n’ibikoresho bikomeye byo muri Iberia, Smith & Nephew ukorera mu Bwongereza ni indashyikirwa mu kuvura ibikomere byateye imbere ndetse na sisitemu yihariye y’ihungabana.

• Ibicuruzwa byibanze: Sisitemu yambere yo gucunga ibikomere, ibikoresho byo kureba arthroscopi, hamwe nibikoresho byihungabana byamagufwa.

• Core Portfolio: TRIGEN Interlocking Nail Sisitemu igaragaramo ubuso bwihariye burangiza neza kugirango habeho ingingo zo hasi no gucunga imvune.

6. B. Braun Melsungen AG (Aesculap)

Uhagarariye isonga mu buhanga bw’Ubudage hamwe n’ibikorwa bikomeye by’ibigo n’ibikoresho muri Porutugali (icyicaro gikuru muri Queluz DE Baixo), B. Braun aha ibigo nderabuzima bya Porutugali ibikoresho birebire bidasanzwe, byakozwe neza n’ihungabana.

• Ibicuruzwa byibanze: Sisitemu yo kuvura infusion, ibikoresho byo kubaga, gutera umugongo, hamwe nibikoresho byihungabana byubaka.

• Core Portfolio: Targon Interlocking Nail Sisitemu itanga uburyo bwo gufunga neza kugirango isabe ko hubakwa amagufwa maremare maremare na tibia.

7. Medtronic plc

Nubwo yiganjemo cyane pacemakers hamwe nibikoresho byumugongo, Medtronic yuburyo bwa osteo-divisiyoneri itanga ibisabwa bigoye gukosora ihungabana ryinshi mubice byubuzima byo muri Porutugali.

• Ibicuruzwa byibanze: Ibyuma byumugongo, imiyoboro igezweho yo kugendana, ibikoresho byo kubaga neurosurgie, hamwe n’ihungabana ryihariye.

• Core Portfolio: Ibikoresho byoroheje byashushanyije bifatanyijemo ibishushanyo mbonera byose bikwiranye no kwiyubaka cyane.

8. Orthofix Ubuvuzi Inc.

Orthofix

• Ibicuruzwa byibanze: Amakadiri yo gukosora hanze, kuvura amagufwa yo gukura kwamagufwa, hamwe ninteko yihariye yo guteranya ingingo-kwagura inteko.

• Core Portfolio: Sisitemu yihariye y’abana n’abakuze sisitemu yo gutera imisumari yibanda ku gucunga inenge zikomeye za intertrochanteric cyangwa shaft.

9. Yemewe LLC

Acumed yibanze ku buryo budasanzwe bwo kuvunika hejuru, gutanga ibikoresho byihariye bitoneshwa nigitugu hamwe ninzobere-zo hejuru-zo mu bitaro byigenga bya Porutugali.

• Ibicuruzwa byibanze: Isahani yo gufunga Anatomique, sisitemu yihariye ya osteotomy, hamwe nintego yo hejuru-ikabije inkoni.

• Core Portfolio: Hasi-yerekana-humeral intramedullary imisumari hamwe ninkoni yintoki zagenewe kugabanya ingirabuzimafatizo zoroshye.

10. Globus Medical, Inc.

Nyuma yo guhuza kwamamaye cyane na NuVasive, Ubuvuzi bwa Globus bwaguye byihuse ihahamuka no kwiyubaka mu bice by’ubuvuzi byigenga mu Burayi bw’Amajyepfo.

• Ibicuruzwa byibanze: Ibisubizo byuzuye bya musculoskeletal, ibyuma byumugongo bigezweho, hamwe na robo-ifashwa no guhahamuka.

• Core Portfolio: CAPTIVATE Trauma Sisitemu, igaragaramo ibikoresho byoroheje bigenewe guhuza neza femur na tibia.

11. Itsinda ry'ubuvuzi rya Wright NV (Isosiyete ya Stryker)

Gukorera mu muryango w’ihungabana rya Stryker, umurage wa Wright Medical umurage wo hasi hamwe nibikoresho byamaguru-ibirenge bikomeje kuba amahitamo yambere yo kwiyubaka hamwe no guhuza hamwe muri Porutugali.

• Ibicuruzwa byibanze: Gutera hejuru hejuru, gusimbuza amaguru yose, hamwe no gutera amagufwa ya orthobiologic.

• Core Portfolio: Retrograde yihariye ya retfograde hamwe nudukoni twa fusion inkoni zagenewe kubaga arthrodezi igoye.

12. Aap Implantate AG

Aap Implantate ni uruganda rukorera mu Budage ruzwiho kwinjiza udushya twa feza hamwe na tekinoroji yo gufunga antibacterial igamije kugabanya indwara ziterwa no guterwa.

• Ibicuruzwa byibanze: LOQTEQ ifunga isahani yumuryango hamwe na antibacterial ihahamuka yatewe na silver.

• Core Portfolio: Sisitemu yo gufatanya kandi ikomeye ya titanium yubatswe kugirango igabanye ibibazo nyuma yibikorwa mugihe cyo kumara amagufwa maremare.

13. CarboFix Orthopedics Ltd.

CarboFix ni intangarugero mu ikoranabuhanga rya karubone-fibre, itanga igitekerezo cyihariye cyo kubaga amagufwa ya onkologiya ajyanye no kubaga amagufwa hirya no hino mu bigo byihariye bya kanseri bya Porutugali.

• Ibicuruzwa byibanze: Caribre fibre yashimangiye plaque plaque, imisumari ya karubone yubatswe, hamwe n’ihungabana rya radiolucent.

• Core Portfolio: Imisumari ya Piccolo, itanga amashusho asobanutse, adafite ibihangano mugihe cyo gukurikirana oncologiya no kuvura imirasire.

14. MicroPort Corporate Corporation

Gukoresha ibikorwa remezo byagutse mu nganda, MicroPort ikwirakwiza uburyo buhendutse, bwinshi cyane bwumutima nimiyoboro yimitsi ndetse na orthopedic muburyo bwu Burayi bwamajyepfo kugirango huzuzwe ingengo yimari y’ibitaro.

• Ibicuruzwa byibanze: Byoroheje byibasira umutima nimiyoboro yimitsi, prothèse hamwe, hamwe nibikoresho byuzuye byo guhahamuka.

• Core Portfolio: Guhuza imisumari yimisumari ikozwe muburyo bwo gusubiramo, byoroshye.

15. Wego Ortho (Itsinda rya Weigao)

Wego Ortho ni umwe mu mashyirahamwe manini y’ubuvuzi ya Aziya, atanga imiti y’ubuvuzi yizewe cyane yujuje ibyifuzo by’ubuvuzi by’i Burayi.

• Ibicuruzwa byibanze: Ibikoresho byo gukosora umugongo, ibyapa byihungabana byubatswe, prothèse ihuriweho, hamwe nibikoresho byo kubaga sterile.

• Core Portfolio: Ibarura ryinshi rya titanium irambye ihuza imisumari igenewe amasezerano yo gutanga amasoko rusange yo mukarere muri Porutugali.

MATRIX YO GUHITAMO UMUSARURO ──

Ibibazo Bikunze Kubazwa (Ibibazo)

Q1: Ese imisumari idasanzwe isabwa ku isoko rya Porutugali ikeneye CE Gushira akamenyetso kuri EU MDR?

Yego rwose. Nyuma y’ishyirwa mu bikorwa ry’amabwiriza y’ibikoresho by’ubuvuzi by’i Burayi (MDR 2017/745), imisumari yose yinjiye muri Porutugali igomba kuba ifite CE Ikimenyetso cyemewe na MDR . Icyiciro cya IIb nicyiciro cya III Ibikoresho byatewe mu magufa bahura nisuzuma rikomeye ryamavuriro, ubugenzuzi bwibyangombwa bya tekiniki, hamwe n’ubuvuzi bukurikira nyuma y’isoko (PMCF). Abashinzwe gutanga amasoko bagomba kwemeza ko uruganda mpuzamahanga rwose, nka CZMEDITECH , rutanga imenyekanisha ryuzuzanya kandi rwanditswe byuzuye mububiko bwa EUDAMED .

Q2: Nibihe bisabwa byihariye byo kwiyandikisha hamwe na INFARMED?

Ndetse hamwe na CE Ikimenyetso, ibikoresho byose byubuvuzi byatanzwe muri Porutugali bigomba kwandikwa kandi bikamenyeshwa INFARMED ( Autoridade Nacional do Medicamento e Produtos de Saúde, IP ) binyuze kumurongo wigihugu wandika ibikoresho byubuvuzi. Inzego zubucuruzi zaho zigomba kwemeza ko ibikoresho byashyizwe mububiko bwuzuye INFARMED mbere yuko ibicuruzwa bigurishwa byemewe cyangwa bigashyikirizwa amasoko y'ibitaro bya leta.

Q3: Kuki sisitemu ya Helical Blade (nka PFNA) ishyirwa imbere cyane muri Unidades Locais de Saúde (ULS)?

Porutugali ihura n’imiterere y’imibare ishaje cyane, bigatuma umubare munini w’imvune za osteoporotic proximal femorale (ikibuno) mu bitaro bya Leta. Imiyoboro gakondo ya lag akenshi inanirwa binyuze mumashini 'gukata ' muburyo bwamagufwa. Gushakisha sisitemu zateye imbere nka CZMEDITECH 'PFNA, ikoresha icyuma gifite imbaraga zo kwikuramo aho gutobora ingirangingo zamagufwa, byongera ihinduka ryimyanya ndangagitsina kandi bikarinda cyane ibitaro byinjira cyane - icyerekezo cyingenzi cyerekana ingengo yimari yubuvuzi bwa kijyambere ya ULS.

Q4: Nigute amasoko yibanze binyuze muri SPMS agira ingaruka kumasoko ya IM imisumari?

SPMS Serviços ( Partilhados do Ministério da Saúde ) icunga amasezerano yibanze, imyaka myinshi ( Acordos-Quadro ) kubikoresho byubuvuzi muri Porutugali. Amasoko ya Leta asuzuma ibyifuzo bishingiye ku guhuza ubumenyi bwa tekiniki (kubahiriza ibikoresho nka Grade 5 Titanium, gutekinika kwa mashini, hamwe na ergonomique) hamwe nubukungu bukora neza. Inganda zisi zishobora gutanga sisitemu zuzuye, zubahiriza amategeko mubikorwa byapiganwa bihiganwa cyane (nka CZMEDITECH ) byashyizwe muburyo bwiza bwo gutsindira amasezerano yubuzima rusange bushingiye ku mubare.

Q5: Ni ubuhe buryo bwo gukurikirana no kwerekana ibimenyetso ari itegeko imbere mu bibuga by'imikino bya Porutugali?

Porutugali yubahiriza byimazeyo sisitemu yu Burayi (Unique Device Identification) . Buri musumari winjiye hamwe na inter Sikulufu ifunga ugomba kwerekana kode ya kodegisi (DataMatrix) itanga ibisobanuro byuzuye kuva ku musaruro kugeza ku barwayi bafite ubuzima bwa digitale ( Registo de Saúde Eletrónico ). Byongeye kandi, ibirango byibicuruzwa nigitabo gikubiyemo amabwiriza ( Instruções de Utilização ) bigomba gutangwa neza mu Giporutugali kugira ngo byubahirize amabwiriza y’umutekano w’igihugu.

Q6: Amatsinda yibitaro bya Porutugali ashobora guhuza imirongo myinshi y’ihungabana kuva uruganda rumwe rukora?

Nibyo, kandi ibi birashishikarizwa cyane kubiciro no gutezimbere ubuyobozi. Guhuriza hamwe umurongo w’ihungabana binyuze mu bafatanyabikorwa bonyine batuma amatsinda y’ibitaro bya Porutugali (nka CUF cyangwa Luz Saúde) cyangwa ULS yo mu karere agura ibigo byunguka kugirango yungukire mubukungu bwikigereranyo. Gushakisha biva mu ruganda rukora nka CZMEDITECH rutuma umuyoboro wibitaro ushobora kubona Imisumari yumugore, Imisumari ya Tibial, ibyapa bifunga anatomiki, hamwe na Ibikoresho by'amashanyarazi byo kwa muganga icyarimwe - koroshya imicungire y inyemezabuguzi, kugabanya ibicuruzwa bitwara ibicuruzwa, no kwemeza ibikoresho bisanzwe byo kubaga bikorerwa kumurongo wibyumba bikoreramo.

Umwanzuro

Mu gihe ibirango gakondo by’umurage wo muri Amerika y'Amajyaruguru no mu Burayi bwo hagati bikomeje kugira imigabane ikomeye ku isoko ry’amateka mu bigo byo mu cyiciro cya mbere cya Porutugali, ubwiyongere bw’amafaranga bukenewe kuri Serviço Nacional de Saúde (SNS) bwatumye abantu bakora inganda zikomeye kandi zemewe ku isi. Abatanga nka CZMEDITECH CE ISO