Baetsi ba Lipekere ba 15 ba ka Sehloohong ba Intramedullary naheng ea Belgium (2026 Tataiso ea Theko)

Selelekela

Boemo ba theko ea lisebelisoa tsa bongaka lekaleng la masapo la Belgium le na le phetoho e potlakileng ea sebopeho. E tsamaisoa ke litaelo tse thata tsa ho boloka litšenyehelo tse tsoang ho Federal Public Service (FPS) Bophelo bo Botle ba Sechaba, Tšireletseho ea Lijo le Tikoloho le maemo a sithabetsang a phahameng a tsamaisoang ke marang-rang a mangata a sepetlele-joaloka ZNA/GZA (Antwerp), CHC (Liège), Grand Hôpital de Charleroi, le litsi tse etellang pele tsa thuto e phahameng joalo ka UZ Leuven le poraefete e ikemetseng ea St. liboto tsa thepa li etelletsa pele li-implants tse fanang ka tekanyo e nepahetseng ea ts'ebetso ea bongaka, ts'ireletso ea taolo, le tekanyetso ea tekanyetso.

Ha u laola ho robeha ha masapo a malelele, ho khetha molekane ea nepahetseng oa lipekere oa intramedullary (IM) ho bohlokoa bakeng sa ho fokotsa mathata a morao-rao le ho laola litšenyehelo tsa mekhatlo tlas'a moralo oa Belgian Overheidsopdrachten / Marchés Publics (Public Procurement Law). Tataiso ena e hlahisa Baetsi ba Lipekere ba 15 ba Intramedullary ba Belgium, ba tsepamisitse maikutlo ho li-portfolio tsa bona tsa mantlha, botumo ba 'maraka, le theknoloji ea mantlha ho thusa baenjiniere ba bongaka, lingaka tsa masapo le batsamaisi ba ketane ea phepelo ho etsa liqeto tse tsamaellanang le data.

Katoloso ea Theknoloji: Ho Utloisisa Meetso e Khethehileng ea Intramedullary Nail ho Modern Trauma Sourcing

Tlhahlobong e felletseng ea bongaka ho pholletsa le lits'ebeletso tsa bophelo bo botle tse etellang pele, ho reka ha masapo ho hloka kutloisiso e tebileng ea tekheniki ea mechini e kentsoeng. Lipekere tsa Intramedullary ha li sa le melamu ea tšepe e tloaelehileng; Opereishene ea sejoale-joale e hloka meralo e ikhethang ea biomechanical e lumellanang le tlhophiso e khethehileng ea fracture le pathology ea mokuli.

Ho thusa liboto tsa lipetlele le likomiti tsa ho buoa ho fokotsa ts'oaetso, ho bohlokoa ho utloisisa likarolo tse ikhethileng tsa Intramedullary Nails tse laolang liholo tsa sejoale-joale tsa masapo:

1. Lipekere tsa Intramedullary tse Kopantsoeng (Solid vs. Cannulated)

Khetho pakeng tsa meralo e tiileng le e kentsoeng ea manala e ama haholo ts'ebetso ea ho buoa le pholiso ea masapo a baeloji.

• Cannulated Intramedullary Nails  : Lipekere tsena li na le setsi se sekoti, se lumellang hore li kenngoe holim'a terata ea tataiso. Moralo ona o thusa lingaka tse buoang ho kenya reamed, e leng ho atolosa kanale ea medulla, e lumellang hore ho be le sepekere se seholoanyane, se matla, 'me se behe likaroloana tsa sebaka sa masapo ka ho toba sebakeng sa ho robeha ho potlakisa ho fola.

• Lipekere tse tiileng tsa Intramedullary: Haholo-holo li sebelisoa mekhoeng e sa reroang, hangata lipekere tse tiileng li khethoa maemong a matla a bulehileng kapa maemong a polytrauma ho fokotsa kotsi ea embolism ea mafura le ho fokotsa tšitiso ea phepelo ea mali ea endosteal.

2. Cephalomedullary Nails & Proximal Femoral Systems

Bakeng sa fractures e hlahang qetellong ea femur (sebaka sa noka), lipekere tse tloaelehileng tsa ho koala ha lia lekana. Litsamaiso tse khethehileng tsa cephalomedullary lia hlokahala ho sebetsana le meroalo e feteletseng ea 'mele.

• Litlhophiso tsa Locking Locking : Meralo ena e na le masoba a ikhethileng a ka morao ho likhato tse 130 ho isa ho tse 135, tse lumellang li-screw tse boima hore li fetele ka har'a lenala ka ho toba hloohong ea botšehali, ho boloka maqheka a subtrochanteric kapa a ipsilateral femoral shaft.

• Anti-Rotation Helical Blade Systems : E sebelisoa haholo ho robeha ha noka ea geriatric, litsamaiso tsena li nka sebaka sa li-screw tsa setso tse nang le lehare la khatello. Moralo ona o hatella lesapo le pota-potileng le hlakollang ho fapana le ho le tlosa, ho fokotsa haholo kotsi ea 'cut-out' ho lesapo la osteoporotic.

3. Retrograde vs. Anterograde Long-Bone Nails

Ho itšetlehile ka sebaka sa ho robeha le botšepehi ba lisele tse bonolo, lingaka tse buoang li tlameha ho khetha li-portal tsa ho kena tse fapaneng bakeng sa ho kenya manala.

• Anterograde Sourcing : Li-implants tse kentsoeng ho tloha qetellong ea proximal (mohlala, ho kena ka har'a trochanter bakeng sa ho robeha ha botšehali). Sena se hloka hore manala a khumame ka nepo ho tsamaisana le makhopho a tlhaho.

• Retrograde Sourcing : Li-implants tse kentsoeng ho tloha qetellong ea distal (mohlala, ho kena ka holim'a lengole feela). Lipekere tse khethehileng tsa retrograde femoral li na le mekhoa e ikhethang ea ho notlela distal ho boloka fractures e rarahaneng ea distal third supracondylar.

Li-Giants tsa Indasteri ea Lefatše le Li-brand tse etelletseng pele

1. Stryker Corporation

Sebapali se hlahelletseng marang-rang a liunivesithi tsa tier-1 tsa Belgium le litsing tsa khatello ea maikutlo tse phahameng haholo, Stryker e thehiloeng US e hlomphuoa haholo ka boenjiniere ba eona bo nepahetseng le tšehetso e matla ea khoebo.

• Lihlahisoa tsa mantlha: Liphetoho tse kopanetsoeng, li-platform tse thusoang ke liroboto (Mako), lisebelisoa tsa neurotechnology, le mekhoa e tsoetseng pele ea ho lokisa mahlomola.

• Core Portfolio: The Gamma4 Trochanteric Nail System le T2 Alpha Interlocking Nail System e fana ka botsitso bo tsoetseng pele ba mochini le litlhophiso tsa lisebelisoa tse lebisitsoeng.

2. DePuy Synthes (Johnson & Johnson MedTech)

Kaha DePuy Synthes e na le boemo bo tebileng ho mafapha a lipetlele tsa sechaba le tsa poraefete naheng ea Belgium, e sebelisa lilemo tse mashome tsa lipatlisiso tsa bongaka tse tšehelitsoeng ke AO Foundation.

• Lihlahisoa tsa mantlha: Mekhoa e felletseng ea ts'oaetso, litharollo tsa kaho e kopaneng, lisebelisoa tsa craniomaxillofacial, le li-biomaterials tsa mokokotlo.

• Core Portfolio: Setsebi sa Nail System le TFNA (Trochanteric Fixation Nail Advanced) li sebelisa mekhoa ea phekolo ea tšepe e ntlafalitsoeng bakeng sa ho robeha ha masapo a trochanteric le a malelele.

3. CZMEDITECH

E le setsi se tsebahalang lefatšeng ka bophara lisebelisoa tsa bongaka tsa masapo, CZMEDITECH e thehile sebaka sa phepelo se ntseng se hola 'marakeng oa Benelux, haholo-holo ka hare ho Belgium. E tsebahala ka ho koala lekhalo lipakeng tsa boenjiniere ba boemo bo holimo ba Jeremane le katleho e phahameng ea tlholisano ea tlhahiso, khamphani e fana ka sethala se felletseng sa ts'oaetso se tšoereng tumello e tiileng ea bongaka ea machabeng - ho kenyeletsoa ISO 13485, CE, litifikeiti - e leng se etsang hore e be molekane ea loketseng bakeng sa k'hamphani e kholo ea Hôpitaux Universitaires / Universitaires / Universitaire and Universitaire theko ea thepa tlas'a litaelo tsa European Public Procurement.

• Mekhoa ea Meriana ea Meriana ea Meriana: Ho Kopana ho Tsoetseng Pele Lipekere tsa Intramedullary , Anatomical Locking Plates & Screws, le Lits'ebetso tsa ho Lokisa ka Ntle.

• Litharollo tsa ho Lokisoa ha Mokokotlo : Anterior / Posterior Cervical & Thoracolumbar Systems, Interbody Fusion Cages, le Spinal Fixation Rods.

• Li-implants tsa Cranio-Maxillofacial (CMF) : Li-Plate tsa Titanium tsa boemo bo tlaase haholo le Mesh Systems bakeng sa ho tsosolosa sefahleho.

• Lisebelisoa le Lisebelisoa tsa Matla a ho Buoa: Li-Drill tsa Orthopedic tse sebetsang hantle haholo, li-Saw tse Oscillating, le lisebelisoa tsa lisebelisoa tse tšoanang tsa sterilization.

• Litšebeletso tse Ikemetseng tsa OEM/ODM : Ho etsa lisebelisoa tsa bongaka tsa ho qetela ho ea qetellong ho tsamaellana le litlhaloso tsa sepetlele sa lefats'e.

• Core IM Nail Portfolio & Lihokelo:

  • Femoral Intramedullary Nail: E entsoe ho tloha ho implant-grade Titanium Alloy (Ti-6Al-4V ELI), e nang le optimized anatomical curvature le multi-planar locking configurations ho fana ka tokiso e thata bakeng sa fractures e rarahaneng ea shaft.

  • Tibial Intramedullary Nail: E entsoe ka likhetho tse tsoelang pele tsa ho notlela tse matla le profil e kentsoeng, e khothaletsang ho jara boima ba 'mele le ho potlakisa pholiso ea masapo.

  • Humeral Intramedullary Nail: Tharollo e khethehileng e holimo-holimo e tsamaisang mokhoa o fokolang, o fokotsang tšitiso ea lisele tse bonolo le ho sireletsa cuff ea rotator.

  • Proximal Femoral Nail Antirotation - PFNA : E na le tsamaiso ea helical blade e ntlafalitsoeng bakeng sa bakuli ba geriatric ba nang le mehaho ea masapo a masapo, ho netefatsa ho hanyetsa ho phahameng khahlanong le ho khaola nakong ea trochanteric fracture fixation.

4. Zimmer Biomet Holdings, Inc.

Zimmer Biomet e kopanya li-platform tsa tlhokomelo ea bophelo bo botle ba dijithale ka theknoloji ea premium ea ho lokisa mesifa le masapo, e sebeletsang marang-rang a maholo a bophelo bo botle ho pholletsa le Brussels, Flanders le Wallonia.

• Lihlahisoa tsa mantlha: Metrics ea bophelo bo botle ba dijithale e tsamaellanang, ho nkela sebaka ka kopanelo, lisebelisoa tsa meriana ea lipapali, le li-implants tsa trauma.

• Core Portfolio: The Natural Nail System e na le li-curvature tsa anatomical tse etselitsoeng ho lumellana le mefuta e fapaneng ea li-morphology ho pholletsa le palo ea batho ba Europe.

5. Smith & Nephew plc

Ka ts'ebetso e sebetsang ka kotloloho le li-hubs tse matla tsa thepa ho pholletsa le Europe Bophirima, Smith & Nephew ea UK e ipabola ka tlhokomelo e tsoetseng pele ea maqeba le lits'ebetso tse khethehileng tsa maqeba.

• Lihlahisoa tsa mantlha: Litsamaiso tse tsoetseng pele tsa taolo ea maqeba, lisebelisoa tsa pono ea arthroscopy, le lisebelisoa tsa ts'oaetso ea masapo.

• Core Portfolio: The TRIGEN Interlocking Nail System e na le lisebelisoa tse khethehileng tsa bokaholimo tse ntlafalitsoeng bakeng sa taolo e matla ea maoto le matsoho a tlase.

6. B. Braun Melsungen AG (Aesculap)

E emela boenjiniere ba boemo bo phahameng ba Jeremane bo nang le khoebo e matla ka mokhoa o makatsang le maqhama a tebileng a lehae naheng ea Belgium (e nang le liofisi tsa bohlokoa Diegem), B. Braun e fana ka litsi tsa kliniki tsa Belgian tse nang le tlhophiso e tšoarellang ea nako e telele, e entsoeng ka mokhoa o nepahetseng.

• Lihlahisoa tsa mantlha: Mekhoa ea phekolo ea infusion, lisebelisoa tsa ho buoa, li-implants tsa mokokotlo, le lisebelisoa tsa ts'oaetso ea sebopeho.

• Core Portfolio: Targon Interlocking Nail System e fana ka ts'ebetso e phahameng ea ho notlela bakeng sa ho batla ho tsosolosoa ha marapo a malelele a femur le tibia.

7. Medtronic plc

Le hoja e le ea bohlokoa haholo ho li-pacemaker le lisebelisoa tsa mokokotlo, Medtronic's structural osteo-division e fana ka litlhoko tse rarahaneng tsa ho lokisa likotsi tse ngata ka har'a lihlopha tsa sepetlele sa Belgian.

• Lihlahisoa tsa mantlha: Lisebelisoa tsa mokokotlo, li-platform tsa ho sesa tse tsoetseng pele, lisebelisoa tsa neurosurgery, le li-implants tse khethehileng tsa ts'oaetso.

• Core Portfolio: Meralo ea lisebelisoa tse feto-fetohang tse kopantsoeng le litlhophiso tse hokahaneng tsa bokahohleng tse loketseng kaho e phahameng ea marapo.

8. Orthofix Medical Inc.

Orthofix e ipabola ka ho kopanya lifilosofi tsa ho lokisa kahare le kantle, e fana ka likhetho tse ikhethang tsa ntlafatso ea baeloji bakeng sa litsebi tsa masapo ho pholletsa le Belgium.

• Lihlahisoa tsa mantlha: Liforeimi tsa ho lokisa ka ntle, liphekolo tse matlafatsang ho hola ha masapo, le likopano tse khethehileng tsa intramedullary tsa ho lelefatsa maoto le matsoho.

• Core Portfolio: Litsamaiso tse khethehileng tsa bana le batho ba baholo ba nang le lipekere tse shebaneng le ho laola bofokoli bo matla ba intertrochanteric kapa shaft bone.

9. Acumed LLC

Acumed e shebana le ho nepahala ha tlhaho bakeng sa fractures e ka holimo, ho fana ka lisebelisoa tse khethehileng tse ratoang ke litsebi tsa matsoho le tsa maoto a ka holimo ho marang-rang a ka sehloohong a Belgium.

• Lihlahisoa tsa mantlha: Lipoleiti tsa ho notlela tsa anatomical, litsamaiso tse khethehileng tsa osteotomy, le lithupa tsa intramedullary tse lebisitsoeng holimo.

• Core Portfolio: Manala a ka tlase a humeral intramedullary le forearm rods tse etselitsoeng ho fokotsa ho kenella ha lisele tse bonolo.

10. Globus Medical, Inc.

Ka mor'a ho kopana ha morao tjena boemo bo phahameng le NuVasive, Globus Medical e atolositse ka potlako boemo ba eona ba mahlomola le ho tsosolosa marang-rang a lipetlele Europe Bophirimela.

• Lihlahisoa tsa mantlha: Litharollo tse felletseng tsa musculoskeletal, hardware e tsoetseng pele ea mokokotlo, le ts'ebetso ea ts'oaetso ea liroboto.

• Core Portfolio: The CAPTIVATE Trauma System, e nang le lisebelisoa tse lokiselitsoeng hantle tse etselitsoeng ho hokahana hantle ha femur le tibia.

11. Wright Medical Group NV (Khamphani ea A Stryker)

E sebetsa ka har'a lelapa la ts'oaetso ea Stryker, lefa la Wright Medical le tlaase le thepa ea maoto le maqaqailana e ntse e le khetho e ka sehloohong bakeng sa ho tsosolosoa ho rarahaneng le ho kopanya Belgium.

• Lihlahisoa tse ka Sehloohong: Li-implants tse ka holimo, ho nkeloa sebaka ka kakaretso ha maqaqailana, le li-graft tse tsoetseng pele tsa masapo a orthobiologic.

• Core Portfolio: Li-retrograde retrograde hindfoot le maqaqailaneng a fusion rod tse etselitsoeng liopereishene tse rarahaneng tsa arthrosis.

12. Aap Implantate AG

Aap Implantate ke moetsi oa Jeremane ea tsebahalang bakeng sa ho hlahisa liphahlo tsa silevera le mahlale a notlelang a antibacteria a etselitsoeng ho fokotsa ts'oaetso e amanang le implant.

• Lihlahisoa tsa mantlha: Lelapa le notlelang la LOQTEQ le li-implants tsa trauma tsa antibacteria tse koahetsoeng ka silevera.

• Core Portfolio: Lits'ebetso tse kentsoeng le tse tiileng tsa titanium tse hokahaneng tse hahiloeng ho fokotsa mathata a kamora ts'ebetso nakong ea ho kenella ha masapo a malelele.

13. CarboFix Orthopedics Ltd.

CarboFix ke pula-maliboho ho thekenoloji ea carbon-fiber, e fanang ka tlhahiso ea boleng bo ikhethang bakeng sa liopereishene tsa masapo tse amanang le oncology ho pholletsa le likarolo tse khethehileng tsa mofetše tsa Belgium.

• Lihlahisoa tsa mantlha: Lipoleiti tsa polymer tse matlafalitsoeng ka carbon fiber, lipekere tsa khabone ea sebopeho, le li-implants tsa trauma ea radiolucent.

• Core Portfolio: Piccolo Composite Nails, e lumellang litšoantšo tse hlakileng, tse se nang li-artifact nakong ea tatellano ea oncological le sepheo sa kalafo ea radiation.

14. MicroPort Scientific Corporation

Ka ho sebelisa lits'ebetso tse atolositsoeng tsa indasteri, MicroPort e tsamaisa likhetho tse theko e tlaase, tse phahameng haholo tsa pelo le methapo ea masapo ho pholletsa le liteishene tsa Europe Bophirima ho kopana le litekanyetso tse thata tsa lichelete tsa sepetlele.

• Lihlahisoa tsa mantlha: Li-stents tse fokolang tsa pelo, li-prostheses tse kopantsoeng, le lisebelisoa tse feletseng tsa ho lokisa mahlomola.

• Core Portfolio: Lits'ebetso tse hokahaneng tsa lipekere tsa intramedullary tse etselitsoeng mekhoa e pheta-phetoang, e bonolo ea ho kenya.

15. Wego Ortho (Weigao Group)

Wego Ortho ke e 'ngoe ea lik'hamphani tse kholo ka ho fetisisa tsa bongaka tsa Asia, tse fanang ka li-implants tse tšepahalang haholo tsa boemo ba bongaka tse fihlelang litlhoko tse matla tsa bongaka tsa Europe.

• Lihlahisoa tsa mantlha: Lisebelisoa tsa ho lokisa mokokotlo, lipoleiti tsa ts'oaetso ea sebopeho, li-prostheses tse kopantsoeng, le lisebelisoa tsa ho buoa tse nyopa.

• Core Portfolio: Lethathamo le pharaletseng la manala a tšoarellang a titanium a lohelletsoeng bakeng sa lithendara tsa sehlopha sa sepetlele sa sechaba sa Belgium.

Katoloso ea Theknoloji: Ho Utloisisa Meetso e Khethehileng ea Intramedullary Nail ho Modern Trauma Sourcing

Tlhahlobong e felletseng ea bongaka ho pholletsa le libaka tse etellang pele tsa tlhokomelo ea bophelo Europe, ho reka ha masapo ho hloka kutloisiso e tebileng ea botekgeniki ea mechini ea ho kenya letsoho. Lipekere tsa Intramedullary ha li sa le melamu ea tšepe e tloaelehileng; Opereishene ea sejoale-joale e hloka meralo e ikhethang ea biomechanical e lumellanang le tlhophiso e khethehileng ea fracture le pathology ea mokuli.

Ho thusa liboto tsa lipetlele le likomiti tsa ho buoa ho theola khatello ea maikutlo, ho bohlokoa ho utloisisa likarolo tse ikhethileng tsa Intramedullary Nails tse laolang liholo tsa sejoale-joale tsa Europe:

1. Lipekere tsa Intramedullary tse Kopantsoeng (Solid vs. Cannulated)

Khetho pakeng tsa meralo e tiileng le e kentsoeng ea manala e ama haholo ts'ebetso ea ho buoa le pholiso ea masapo a baeloji.

• Cannulated Intramedullary Nails: Lipekere tsena li na le setsi se sekoti, se li lumellang hore li kenngoe holim'a terata e tataisang. Moralo ona o thusa lingaka tse buoang ho kenya reamed, e leng ho atolosa kanale ea medulla, e lumellang hore ho be le sepekere se seholoanyane, se matla, 'me se behe likaroloana tsa sebaka sa masapo ka ho toba sebakeng sa ho robeha ho potlakisa ho fola.

• Lipekere tse tiileng tsa Intramedullary: Haholo-holo li sebelisoa mekhoeng e sa reroang, hangata lipekere tse tiileng li khethoa maemong a matla a bulehileng kapa maemong a polytrauma ho fokotsa kotsi ea embolism ea mafura le ho fokotsa tšitiso ea phepelo ea mali ea endosteal.

2. Cephalomedullary Nails & Proximal Femoral Systems

Bakeng sa fractures e hlahang qetellong ea femur (sebaka sa noka), lipekere tse tloaelehileng tsa ho koala ha lia lekana. Litsamaiso tse khethehileng tsa cephalomedullary lia hlokahala ho sebetsana le meroalo e feteletseng ea 'mele.

• Litlhophiso tsa Locking Locking: Meralo ena e na le masoba a ikhethileng a ka morao ho likhato tse 130 ho isa ho tse 135, tse lumellang li-screw tse boima hore li fetelle ka har'a sepekere ka kotloloho hloohong ea botšehali, ho boloka maqheka a subtrochanteric kapa a ipsilateral femoral shaft.

• Anti-Rotation Helical Blade Systems: E sebelisoa haholo ho robeha ha noka ea geriatric, litsamaiso tsena li nka sebaka sa li-screws tsa setso tse nang le lehare la khatello. Moralo ona o hatella lesapo le pota-potileng le hlakollang ho fapana le ho le tlosa, ho fokotsa haholo kotsi ea 'cut-out' ho lesapo la osteoporotic.

3. Retrograde vs. Anterograde Long-Bone Nails

Ho itšetlehile ka sebaka sa ho robeha le botšepehi ba lisele tse bonolo, lingaka tse buoang li tlameha ho khetha li-portal tsa ho kena tse fapaneng bakeng sa ho kenya manala.

• Anterograde Sourcing: Li-implants tse kentsoeng ho tloha pheletsong e haufi (mohlala, ho kena ka har'a trochanter bakeng sa ho robeha ha botšehali). Sena se hloka hore manala a khumame ka nepo ho tsamaisana le makhopho a tlhaho.

• Retrograde Sourcing: Li-implants tse kentsoeng ho tloha pheletsong e ka thoko (mohlala, ho kena ka holim'a lenonyeletso la lengole). Lipekere tse khethehileng tsa retrograde femoral li na le mekhoa e ikhethang ea ho notlela distal ho boloka fractures e rarahaneng ea distal third supracondylar.

── PRODUCT SELECTION MATRIX ──

Lipotso tse atisang ho botsoa (FAQ)

Q1: Na lipekere tsa intramedullary tse hlokahalang bakeng sa mmaraka oa Belgian li hloka ho tšoaea CE tlasa EU MDR?

E, ruri. Ka mor'a ts'ebetso e tiileng ea European Medical Device Regulation (MDR 2017/745), lipekere tsohle tsa intramedullary tse rekisoang Belgium li tlameha ho ba le letšoao la CE le nepahetseng tlas'a tataiso ea MDR . Li-implants tsa masapo tsa Sehlopha sa IIb le tsa Sehlopha sa III li tobane le tlhahlobo e matla ea kliniki, tlhahlobo ea litokomane tsa tekheniki, le ts'ebetso e matla ea kamora 'maraka (PMCF). Batsamaisi ba thepa ba tlameha ho etsa bonnete ba hore moetsi leha e le ofe oa machaba, ea kang CZMEDITECH, o fana ka Phatlalatso ea Conformity 'me o ngolisitsoe ka botlalo ka har'a database ea EUDAMED .

Q2: Ke litlhoko life tse ikhethileng tsa ho ingolisa le FAMHP / FAGG?

Leha ho na le CE Mark e sebetsang, sesebelisoa leha e le sefe sa bongaka se ajoang kapa se rekisoang ka hare ho Belgium se tlameha ho tsebisoa le ho ngolisoa polokelong ea litaba ea naha e laoloang ke FAMHP (Federal Agency for Medicines and Health Products) / FAGG (Federaal Agentschap voor Geneesmidelen en Gezondheidsproducten) . Barekisi, barekisi, kapa baemeli ba nang le tumello ea lehae ba tlameha ho ngolisa lihlahisoa ka portal ea inthaneteng pele ba ka nka karolo ka molao ho lithendara tsa marang-rang a lipetlele tsa sechaba.

Q3: Ke hobane'ng ha litsamaiso tsa Helical Blade (joaloka PFNA) li etelletsoa pele haholo marang-rang a sepetlele sa Belgian (mohlala, ZNA, UZ Leuven)?

Belgium e na le palo ea batho ba tsofalang ka potlako, e leng se lebisang keketsehong ea ho robeha ha litho tsa botšehali ho proximal proximal femoral. Likurufu tsa khale tsa lag hangata li hloleha ka 'cut-out' ea mochini lesapong le fokolang. Ho fumana lits'ebetso tse tsoetseng pele joalo ka CZMEDITECH's PFNA, e sebelisang lehare le matla la helical ho hatella ho fapana le ho phunya lisele tsa masapo, ho eketsa botsitso ba ho potoloha le ho thibela haholo ho bala lipetlele tse theko e boima le litokiso - litekanyetso tsa bohlokoa tsa lintlha ho lithendara tse kopaneng tsa marang-rang a lipetlele tse ngata.

Q4: Ho kopanngoa ha marang-rang a sepetlele sa Belgian ho ama joang ho fumana lipekere tsa IM?

Sebopeho sa mehleng ea kajeno sa Belgian se hlalosoa haholo ka ho kopanngoa ha lipetlele ho ea ka marang-rang a libaka (mohlala, marang-rang a 13 a kliniki Flanders le Wallonia). Marang-rang ana a etsa lithendara tse kholo, tse nang le libaka tse ngata tlasa melaoana ea Overheidsopdrachten / Marchés Publics , e shebaneng haholo le Theko e Thehiloeng ka Boleng . Lithendara li lekola boleng ba tekheniki (joalo ka ho latela melao ea Titanium ea Kereiti ea 5, lintlha tsa polokeho ea thepa e tala, le lisebelisoa tsa ergonomics) hammoho le ts'ebetso ea lichelete. Baetsi ba fanang ka lintlha tsa premium tsa mochini tse nang le ts'ebetso e ntlafalitsoeng (joalo ka CZMEDITECH) ba hlolisanoa haholo ho hapeng likonteraka tsena tsa lihlopha tsa lilemo tse ngata.

Q5: Ke taolo efe le taolo ea puo e hlokahalang bakeng sa li-implants ka har'a lipetlele tsa Belgian?

Belgium e tiisa ka thata tsamaiso ea UDI (Unique Device Identification) tlas'a taelo ea EU, e netefatsa hore ho na le ts'ebetso e feletseng ho tloha ho moetsi ho ea ho rekoto e khethehileng ea bophelo bo botle ba mokuli ( Elektronisch Patiëntendossier / Dossier Médical Électronique ). Ho feta moo, Litaelo tsohle tsa Tšebeliso (IFU), li-laible, le litataiso tsa ho buoa li tlameha ho lumellana ka thata le litlhoko tsa lipuo tse tharo tsa Belgium (Dutch, French, and English), ho itšetlehile ka sebaka sa sebaka seo marang-rang a sepetlele a leng ho sona.

Q6: Na marang-rang a sepetlele sa Belgian a ka kopanya mela e mengata ea mahlomola ho tsoa ho moetsi a le mong oa machaba?

E, 'me sena se khothaletsoa haholo bakeng sa litšenyehelo le ntlafatso ea tsamaiso. Ho kopanya mela ea mahlomola ka molekane a le mong ea tobileng kapa mofani ea lumelletsoeng oa mohloli o le mong ho lumella marang-rang a kopantsoeng a sepetlele sa Belgian ho rua molemo moruong o moholo. Ho fumana chelete ho tsoa ho moetsi o kopantsoeng joalo ka CZMEDITECH ho lumella marang-rang a sepetlele ho fumana lipekere tsa basali, lipekere tsa Tibial, lipoleiti tsa ho notlela tsa anatomical, le lisebelisoa tsa matla a bongaka ka nako e le 'ngoe-ho ntlafatsa tsamaiso ea li-invoice tsa tsamaiso, ho fokotsa likhahla tsa carbon tse amanang le thepa, le ho etsa bonnete ba hore lisebelisoa tsa ho buoa li lekana ho pholletsa le marang-rang a kamore ea ho sebetsa.

Qetello

Le ha lihlahisoa tsa setso tsa Amerika Leboea le Europe Bohareng li ntse li tsoela pele ho ba le likarolo tsa bohlokoa tsa mmaraka marang-rang a tier-1 a Belgium, likhatello tse ntseng li eketseha tsa lichelete mabapi le lichelete tsa bophelo bo botle ba sechaba li entse hore ho be le bahlahisi ba tsofetseng, ba netefalitsoeng lefatšeng ka bophara. Bafani ba rata CZMEDITECH e fana ka tlhahiso ea boleng bo matla haholo bakeng sa likarolo tsa morao-rao tsa Belgium ka ho bapisa litifikeiti tsa pele tsa bongaka tsa Europe (CE/ISO) le thepa e tala ea boemo bo holimo e nang le meaho e ntlafalitsoeng haholo ea tlhahiso.