Abakozi 15 ba mbere binjiza imisumari muri Espagne (2026 Igitabo cyamasoko)

Intangiriro

Isoko ryo kugura ibikoresho byubuvuzi murwego rwamagufwa ya Espagne ririmo ihindagurika ryihuse. Bitewe na manda zikaze zitangwa na minisiteri yubuzima ( Ministerio de Sanidad ) hamwe n’ubushobozi bwo kwegereza ubuyobozi abaturage serivisi z’ubuzima bwigenga ( Servicios de Salud Autonómicos ) - nka SERMAS (Madrid), SAS (Andalucía), Catsalut (Cataluña), hamwe n’itsinda rya SACYL (Castilla y León); Vithas - inama zitanga amasoko y'ibitaro zishyira imbere gushyiramo impanuro zitanga impuzandengo nziza yimikorere yubuvuzi, umutekano wigenga, hamwe ningengo yimishinga.

Mugihe ucunga amagufwa maremare, guhitamo neza umusumari wimisumari (IM) ningirakamaro mukugabanya ibibazo nyuma yibikorwa no gucunga ibiciro byinzego murwego rwa Licitaciones Públicas (Amasoko rusange). Aka gatabo kerekana urutonde rwambere 15 rwambere rukora imisumari muri Espagne, rwibanda kubikorwa byabo byambere, kumenyekanisha isoko, hamwe nikoranabuhanga ryibanze ryo gufasha injeniyeri yubuvuzi bw’ibinyabuzima, kubaga amagufwa, hamwe n’abashinzwe gutanga amasoko mu gufata ibyemezo bishingiye ku makuru.

Kwagura Tekinike: Gusobanukirwa Ibishushanyo Byihariye Byashushanyijeho Imisumari ya kijyambere

Mu isuzuma ryuzuye ry’amasoko y’ubuvuzi hirya no hino mu bigo byita ku buzima, amasoko y’ihungabana ya orthopedic 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 imbaho ​​zibitaro na komite zishinzwe kubaga koroshya ihahamuka, ni ngombwa gusobanukirwa ibyiciro byibanze byihariye byimisumari ya Intramedullary yiganjemo inzu yimyidagaduro igezweho:

1. Guhuza imisumari yimbere (Solid vs Cannulated)

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

• Imisumari ya Cannulated Intramedullary  : Iyi misumari igaragara hagati yubusa, ibemerera kwinjizwa hejuru yumugozi uyobora. Igishushanyo gifasha abaganga gukora insimburangingo yongeye kwaguka, yagura umuyoboro wa medullary, itanga umusumari munini, ukomeye, kandi igashyira ibice byavunitse amagufwa byaho byacitse kugirango byihute gukira.

• Imisumari ikomeye: Imisumari ikoreshwa 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 kuri 135, bigatuma imiyoboro iremereye cyane inyura mu musumari mu mutwe w’umugore, ikavunika ibice bya subtrochanteric cyangwa impande zombi.

• Anti-Rotation Helical Blade Sisitemu : Ikoreshwa cyane cyane 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 yavunitse hamwe nubunyangamugayo bworoshye, abaganga bagomba guhitamo ibinyuranyo byinjira kugirango binjizemo 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 mavuriro yigenga yo mu cyiciro cya 1 cya Espagne hamwe n’ibigo byinshi by’ihungabana bya kaminuza, Stryker ukomoka muri Amerika yubahwa cyane kubera ubuhanga bw’ubuhanga ndetse n’ubufasha bukomeye mu bucuruzi.

• Ibicuruzwa byibanze: Gusimburana hamwe, urubuga rufasha robot (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 imashini igezweho kandi igenewe ibikoresho.

2. DePuy Synthes (Johnson & Johnson MedTech)

DePuy Synthes ifite umwanya ushinze imizi mu nzego za Leta (SNS) ndetse n’ibitaro byigenga byo muri Espagne, ikoresha imyaka mirongo y’ubushakashatsi ku mavuriro ishyigikiwe 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) ikoresha uburyo bwo kuvura ibyuma byateguwe neza kugirango bivunagurwe bigoye kandi bivunika amagufwa maremare.

3. CZMEDITECH

Nimbaraga zizwi kwisi yose mubikoresho byubuvuzi bwamagufwa, CZMEDITECH yashyizeho uburyo bwagutse bwo gutanga isoko ku isoko ry’Uburayi bw’Amajyepfo, cyane cyane muri Espanye. Iyi sosiyete izwiho gukemura icyuho kiri hagati y’ubudage bwo mu rwego rwo hejuru n’ubudage bukora neza kandi bukora neza mu gukora inganda, iyi sosiyete itanga ihahamuka ry’ihungabana rifite ibyemezo mpuzamahanga by’ubuvuzi - harimo ISO 13485, CE ibyemezo bya CE - bituma iba umufatanyabikorwa mwiza w’ibitaro bikuru bya Hospitales Universitarios hamwe n’ubuvuzi bwigenga bushakisha uburyo bwo gutanga amasoko menshi mu mabwiriza agenga amasoko ya Leta y’Uburayi.

• Sisitemu yo guhahamuka ya orthopedic: Guhuza imbere Imisumari yimbere , 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.

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

• Ibikoresho byo kubaga ibikoresho & ibikoresho: Imyitozo yo hejuru ya orthopedic imyitozo, Oscillating Saws, hamwe nibikoresho byo kuboneza urubyaro.

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

• Core IM Nail Portfolio & Ihuza:

  • Femoral Intramedullary Nail: Yakozwe kuva murwego rwoherejwe na Titanium Alloy (Ti-6Al-4V ELI), igaragaramo uburyo bwiza bwo kugabanya anatomical curvature hamwe na planari nyinshi zifunga iboneza kugirango bitange gukosorwa gukomeye kumeneka ya shaft.

  • Tibial Intramedullary Nail: Yashizweho hamwe na progaramu igenda yegerana yingirakamaro yo gufunga hamwe numwirondoro wa kanseri, biteza imbere kubyara kare kandi byihuse gukira amagufwa.

  • Humeral Intramedullary Nail: Igisubizo cyihariye cyo hejuru-cyoroshye cyorohereza uburyo bworoshye bwo gutera, kugabanya ihungabana ryoroshye no kurinda cuff rotateur.

  • Antirotation ya Proximal Femoral Nail - PFNA : Ibiranga sisitemu ya pisitori ikozwe neza kubarwayi bakuze bafite amagufwa ya osteoporotic, 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 sisitemu nkuru yubuzima bwa metropolitani muri Espanye.

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

• Core Portfolio: Sisitemu Kamere Kamere igaragaramo imiterere ya anatomique yagenewe guhuza imiterere itandukanye y’abarwayi mu moko menshi y’uburayi.

5. Smith & Mwishywa plc

Hamwe nibikorwa bitaziguye hamwe n’ibikoresho bikomeye byo mu Burayi bw’iburengerazuba, Smith & Nephew ukorera mu Bwongereza ni indashyikirwa mu kuvura ibikomere 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 hepfo no gucunga imvune.

6. B. Braun Melsungen AG (Aesculap)

B. Braun ahagarariye isonga mu buhanga bw’Ubudage hamwe n’amateka akomeye hamwe n’amasosiyete muri Espagne (icyicaro gikuru i Rubí, Barcelona), B. Braun aha ibigo nderabuzima bya Espagne ibikoresho birebire bidasanzwe, byakozwe 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 Espanye.

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

• Core Portfolio: Ibikoresho byoroheje byashushanyije byahujwe nuburyo rusange bwo guhuza ibereye bikwiranye no kwiyubaka cyane.

8. Orthofix Medical Inc.

Orthofix ni indashyikirwa mu guhuza filozofiya yo mu gihugu imbere no hanze, itanga uburyo bwihariye bwo kuvugurura ibinyabuzima ku nzobere mu by'amagufwa muri Esipanye.

• 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 yibanze 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 Espagne.

• 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 vuba ihahamuka no kwiyubaka mu bice rusange 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 guhitamo icyambere cyo kwiyubaka hamwe no guhuza hamwe muri Espanye.

• 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 silver hamwe na tekinoroji yo gufunga antibacterial igamije kugabanya indwara ziterwa no guterwa.

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

• 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 karuboni-fibre, itanga igitekerezo cyihariye cyo kubaga amagufwa ya oncologiya ajyanye no kubaga amagufwa hirya no hino muri kanseri yihariye ya kanseri.

• Ibicuruzwa byibanze: Caribre fibre yashimangiye ibyapa bya polymer, 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, MicroPort ikwirakwiza uburyo buhendutse, bwinshi bwumutima nimiyoboro yumutima hamwe na orthopedic binyuze mumiyoboro yuburayi bwamajyepfo kugirango huzuzwe ingengo yimari y’ibitaro.

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

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

15. Wego Ortho (Itsinda rya Weigao)

Wego Ortho ni umwe mu mashyirahamwe manini y’ubuvuzi yo muri 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 iramba ihuza imisumari igenewe amasoko rusange yo mu karere muri Espanye.

MATRIX YO GUHITAMO UMUSARURO ──

Ibibazo Bikunze Kubazwa (Ibibazo)

Q1: Ese imisumari yimbere ikenewe kumasoko ya Espagne ikeneye CE Marking muri 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 Espagne igomba kuba ifite ikimenyetso cya CE cyemewe n’amabwiriza ya MDR . Icyiciro cya IIb nicyiciro cya gatatu cyimyitozo ngororamubiri ihura nisuzuma rikomeye ryamavuriro, ubugenzuzi bwibyangombwa bya tekiniki, hamwe nogukurikirana amavuriro nyuma yisoko (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 AEMPS yo muri Espanye?

Ndetse hamwe na CE ikora, ibikoresho byose byubuvuzi byatanzwe muri Espagne bigomba kumenyeshwa AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) binyuze kuri Aplicación de Comunicación de Comercialización de Productos Sanitarios (CCPS). Abatumiza mu mahanga n'abacuruzi baho bagomba kandi kuba bafite Licencia Previa de Funcionamiento de Instalaciones (Uruhushya rwo Gukora Ibikoresho), kugira ngo bagenzure neza imbere mu gihugu mbere yuko ibicuruzwa bitangirwa isoko mu masoko yo mu karere.

Q3: Kuki sisitemu ya Helical Blade (nka PFNA) ishyirwa imbere cyane muri serivisi zubuzima bwakarere (urugero, SERMAS, SAS)?

Espagne ifite kimwe mu byiringiro byo kubaho cyane hamwe n’imiterere ya demokarasi ishaje cyane mu Burayi, bikaviramo umutwaro munini wo kuvunika kwa osteoporotic. Imiyoboro gakondo ya lag akenshi inanirwa binyuze mumashini 'gukata ' mumagufwa adakomeye. Gushakisha sisitemu yateye imbere nka PFNA ya CZMEDITECH, ikoresha icyuma kigira imbaraga zo kwikuramo aho gutobora ingirangingo zamagufwa, byongera ihinduka ryikizunguruka kandi bikarinda cyane kwinjiza ibitaro bihenze no kuvugurura - ingingo zingenzi zerekana amanota mumasezerano rusange yo gutanga amasoko.

Q4: Nigute amategeko agenga amasoko ya Espagne (LCSP) agira ingaruka kumasoko yimisumari ya IM?

Mu mategeko agenga amasoko ya Leta ya Espagne ( Ley de Contratos del Sector Público - LCSP ), amasoko y'ibitaro bya leta ntashobora gushingira gusa ku giciro. Amasoko yubatswe hafi yamasoko ashingiye ku gaciro , aho ubuhanga bwa tekiniki (kubahiriza ibikoresho nka Grade 5 Titanium ASTM F136, ibikoresho bya ergonomique, gukurikirana, hamwe namakuru yubuvuzi) bingana na 50-60% byamanota yose. Inganda zitanga imiterere yubukorikori hamwe nibikoresho byiza (nka CZMEDITECH) bifite imbaraga zo guhatanira.

Q5: Ni ubuhe buryo bwo kugenzura bukenewe kugira ngo imisumari yimbere mu bitaro bya Esipanye?

Espagne yubahiriza byimazeyo gahunda ya UDI (Unique Device Identification) sisitemu ya EU. Buri musumari umwe wimisumari hamwe nu mugozi uhuza bigomba kwerekana sisitemu yo gukurikirana barcode (DataMatrix) itanga ibisobanuro byuzuye kuva uwabikoze kugeza kubuzima bwihariye bwa elegitoroniki (EHR). Abacuruzi baho bagomba gukomeza sisitemu itagira inenge / sisitemu yo gukurikirana kugirango ikore ibintu byihuse cyangwa ibimenyesha umutekano niba byashyizweho na AEMPS.

Q6: Ihuriro ry’ubuzima bwo muri Espagne rishobora guhuza imirongo myinshi y’ihungabana kuva ku ruganda rumwe rukora?

Nibyo, kandi ibi birashishikarizwa cyane kubiciro no gutezimbere ubuyobozi. Guhuriza hamwe umurongo w’ihungabana binyuze mu bafatanyabikorwa bonyine cyangwa abemerewe gukwirakwiza isoko imwe yemerera amatsinda y’ibitaro byo muri Esipanye (nka HM Hospitales cyangwa Quirónsalud) cyangwa ibigo byo kugura uturere kugira ngo bungukirwe nubukungu bwikigereranyo. Gushakisha biva mu ruganda rukomatanyije nka CZMEDITECH rwemerera umuyoboro wibitaro kubona Imisumari yumugore, Imisumari ya Tibial, ibyapa bifunga anatomique, hamwe nibikoresho byubuvuzi icyarimwe - koroshya imicungire yinyemezabuguzi yubuyobozi, kugabanya ibirenge bya karuboni bifitanye isano n’imizigo, 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 mu mateka yo mu cyiciro cya mbere cya Esipanye, icyifuzo cy’amafaranga cyiyongera kuri Sistema Nacional de Salud (SNS) cyatumye abantu bakora inganda zikomeye kandi zemewe ku isi. Abatanga nka CZMEDITECH batanga agaciro gakomeye kubice bya Espagne bigezweho by’ihungabana bahuza ibyemezo by’ubuvuzi by’uburayi (CE MDR) hamwe n’ibikoresho fatizo byo mu rwego rwo hejuru hamwe n’inganda zikora neza.

Umwanzuro

Mu gihe imigenzo gakondo y’umurage w’ibihugu by’i Burayi yo muri Amerika y'Amajyaruguru ikomeje kugira imigabane ikomeye ku isoko ry’amateka mu bigo byo mu cyiciro cya mbere cya Esipanye, icyifuzo cy’amafaranga cyiyongera kuri Sistema Nacional de Salud (SNS) cyatumye abantu bakora inganda zikomeye kandi zemewe ku isi. Abatanga nka CZMEDITECH itanga agaciro gakomeye kubice bya Esipanye bigezweho by’ihungabana muguhuza ibyemezo by’ubuvuzi by’iburayi (CE / ISO) hamwe n’ibikoresho fatizo byo mu rwego rwo hejuru byatewe n’inganda zikora neza.