Top 15 Umusumari wo mu musokoro w'amagufa Abakora 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 no kwegereza abaturage ubuyobozi bw’ihungabana ryinshi ryayobowe na serivisi zita ku buzima bw’abaturage ( Servicios de Salud Autonómicos ) - nka SERMAS (Madrid), SAS (Andalucía), Catsalut (Cataluña), hamwe na SACYL (Castilla y León). Vithas - akanama gashinzwe gutanga amasoko y'ibitaro gashyira imbere gushyirwaho bitanga impanuro nziza yimikorere yubuvuzi, umutekano wubuyobozi, hamwe ningengo yimishinga.

Mugihe ucunga amagufwa maremare, guhitamo neza umusumari wimisumari (IM) nibyingenzi mukugabanya ibibazo nyuma yibikorwa no gucunga ibiciro byinzego murwego rwa Licitaciones Públicas (Amasoko rusange). Aka gatabo kerekana Top 15 Umusumari wo mu musokoro w'amagufa Abakora muri Espagne, bibanda ku nshingano zabo z'ibanze, kumenyekana ku isoko, ndetse n’ikoranabuhanga ry’ibanze ryo gufasha abashakashatsi mu binyabuzima, abaganga b’amagufwa, hamwe n’abashinzwe gutanga amasoko mu gufata ibyemezo bishingiye ku makuru.

Kwagura Tekiniki: 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 na komite zishinzwe kubaga koroshya ihahamuka, ni ngombwa kumva ibyiciro byibanze byihariye bya Imisumari yo mu musokoro w'amagufa byiganje mu makinamico ya orthopedie:

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 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 imisumari isobanutse neza kugirango ihuze na anatomical curvatures.

• Retrograde Sourcing : Implants zinjijwe kuva kumpera ya kure (urugero, kwinjira hejuru yikivi). Imisumari yihariye ya retrograde imisumari 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 no mu bigo byinshi by’ihungabana bya kaminuza, Stryker ukorera 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 iterambere ryimashini hamwe nibikoresho byabigenewe.

2. DePuy Synthes (Johnson & Johnson MedTech)

Ufite imyanya yashinze imizi mu nzego za Leta (SNS) ndetse n’ibigo byigenga by’ibitaro byo muri Espagne, DePuy Synthes ikoresha imyaka mirongo y’ubushakashatsi ku mavuriro bushigikiwe 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

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’icyiciro cya mbere cy’Ubudage n’ubuhanga bwo gukora neza kandi ikora neza cyane mu gukora inganda, isosiyete itanga ihahamuka ry’ihungabana rifite ibyemezo mpuzamahanga by’ubuvuzi - harimo ISO 48 13485, CE ibyemezo-bituma iba umufatanyabikorwa mwiza kuri Hospitales Universitarios n’ibigo byita ku buzima byigenga bigamije kunoza amasoko menshi mu masoko y’uburayi.

• Sisitemu yo guhahamuka ya orthopedic: Guhuza imbere Imisumari yo mu musokoro w'amagufa , Anatomical Ibyuma bifunga & 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 ) Kwimura : 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.

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

• Core IM Nail Portfolio & Ihuza:

  • Femoral Umusumari wo mu musokoro w'amagufa : Yakozwe kuva Titanium Alloy yo mu rwego rwo hejuru (Ti-6Al-4V ELI), igizwe na anatomical curvature igororotse hamwe na planari nyinshi zifunga ibishushanyo kugirango bitange gukosorwa gukomeye kuvunika.

  • Tibial Umusumari wo mu musokoro w'amagufa : Yashizweho hamwe na progaramu igenda yegerana yingirakamaro yo gufunga hamwe nu mwirondoro wa kanseri, biteza imbere kubyara kare kandi byihuse gukira amagufwa.

  • Humeral Umusumari wo mu musokoro w'amagufa : Igisubizo cyihariye cyo hejuru-cyoroshye cyoroshya 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 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 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 ya Kamere igaragaramo imiterere ya anatomique yagenewe guhuza imiterere itandukanye y’abarwayi mu moko atandukanye 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 z’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)

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 kandi byakozwe neza.

• 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 kugirango bikosore ibikomere byinshi 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 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 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: Anatomical Ibyuma bifunga , sisitemu yihariye ya osteotomy, hamwe nintego yo hejuru-hejuru yinkoni.

• 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 guhitamo icyambere cyo kwiyubaka hamwe no guhuza hamwe muri Espanye.

• Ibicuruzwa byibanze: Gutera hejuru hejuru, gusimbuza amaguru yose, hamwe namagufwa ya orthobiologic yateye imbere.

• 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 Icyuma gifunga umuryango hamwe nifeza 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 onkologiya ajyanye no kubaga amagufwa hirya no hino mu bigo byihariye bya kanseri byo muri Esipanye.

• 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 iramba ihuza imisumari igenewe amasoko rusange yo mu karere muri Espanye.

MATRIX YO GUHITAMO UMUSARURO ──

Ibibazo Bikunze Kubazwa (Ibibazo)

Q1: Ese imisumari ikenewe kugirango isoko rya Espagne ikenera CE Kwandika munsi ya MDR ya EU?

Yego rwose. Nyuma y’ishyirwa mu bikorwa ry’amabwiriza y’ibikoresho by’ubuvuzi by’i Burayi (MDR 2017/745), imisumari yose yinjira mu bucuruzi yagurishijwe muri Espagne igomba kuba ifite CE Ikimenyetso cyemewe na MDR . Icyiciro cya IIb na Icyiciro cya III Ibikoresho byatewe mu magufa bahura n’isuzuma rikomeye ry’amavuriro, ubugenzuzi bw’ibyangombwa 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 AEMPS yo muri Espanye?

Ndetse hamwe na CE Mark, 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 mbere y’ibikorwa), bakemeza ko igenzurwa ry’imbere mu gihugu mbere yuko ibicuruzwa bitangwa mu buryo bwemewe n’amasoko 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 hejuru byubuzima hamwe n’imiterere ya demokarasi ishaje cyane mu Burayi, bikaviramo umutwaro munini wo kuvunika osteoporotic hafi ya femorale femorale. Imiyoboro gakondo ya lag akenshi inanirwa binyuze mumashini 'gukata ' mumagufwa adakomeye. Gushakisha sisitemu zateye imbere nka CZMEDITECH 'PFNA, ikoresha icyuma gifite imbaraga zo gukanda aho kwikuramo ibice byamagufwa, byongera ituze ryizunguruka kandi bikarinda cyane ibitaro bihenze no gusubiramo - ingingo zingenzi zerekana amanota mumasezerano rusange yo gutanga isoko.

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 ibyiza bya tekiniki (kubahiriza ibikoresho nka Grade 5 Titanium ASTM F136, ibikoresho bya ergonomique, gukurikirana, hamwe namakuru yubuvuzi) bingana na 50-60% byamanota yose. Abahinguzi batanga imiterere yubukorikori hamwe nibikoresho byiza (nka CZMEDITECH ) bafite imbaraga zo guhatanira.

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

Espagne yubahiriza byimazeyo UDI (Unique Device Identification) sisitemu ya EU. Buri musumari umwe winjiye hamwe na inter Sikulufu ifunga ugomba kwerekana sisitemu yo gukurikirana barcode (DataMatrix) itanga ibisobanuro byuzuye uhereye kubabikora kugeza kubuzima bwihariye bwa elegitoronike (EHR). Abagabuzi baho bagomba gukomeza ubufindo butagira 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 ituruka ku ruganda rumwe mpuzamahanga?

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 kugirango bungukirwe nubukungu bwikigereranyo. Gushakisha ibicuruzwa byakozwe nka CZMEDITECH bituma umuyoboro wibitaro ushobora kubona Imisumari yumugore, Imisumari ya Tibial, anatomical Ibyuma bifunga , na Ibikoresho by'amashanyarazi byo kwa muganga icyarimwe - kunonosora imicungire yimyemerere yubuyobozi, kugabanya ibirenge bya karuboni bifitanye isano n’imizigo, no kwemeza uburyo bwo kubaga ibikoresho bisanzwe biboneka kumurongo wibyumba bikoreramo.

Umwanzuro

Mu gihe ibirango gakondo by’umurage gakondo byo muri Amerika ya Ruguru hamwe n’Uburayi bwo hagati bikomeje kugira imigabane ikomeye ku isoko ry’amateka mu bigo byo mu cyiciro cya mbere cya Esipanye, kwiyongera kw’amafaranga kuri Sistema Nacional de Salud (SNS) byatumye 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’iburayi 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) cyateje imbere inganda zikora cyane, zemewe ku isi. Abatanga nka CZMEDITECH CE ISO