Product Overview
Peb qhov hwm Femoral Stem Implants yog tsim los ua kom tau raws li qhov xav tau nruj ntawm thawj Tag Nrho Hip Arthroplasty (THA) thiab Kev Kho Hniav Kho Hniav. Tsim los ua kom muaj kev ruaj ntseg zoo tshaj plaws, kev ua haujlwm zoo tshaj plaws, thiab lub sijhawm ntev -kev sib xyaw ua ke lom neeg osseointegration, cov kev cog qoob loo no rov ua kom zoo dua qub hip sib koom ua ke biomechanics thiab txhim kho lub sijhawm ntev -cov neeg mob mus.
Tsim los ntawm biocompatible, kho mob-qib Titanium Alloy los yog Cobalt-Chromium Alloy, peb cov femoral stems feature siab heev saum npoo topography. Cov kev kho mob saum npoo zoo li no ua rau cov pob txha ingrowth thiab ua kom muaj kev ruaj ntseg, ruaj khov kho nyob rau hauv femoral kwj dej.
Khoom Specifications
|
Parameter |
Technical Specifications & Variations |
|
Khoom npe |
Kev kho mob-Qib Femoral Stem Implant |
|
Fixation Hom |
Cementless (Nias-Fit) / Cemented Options Muaj |
|
Khoom siv |
Titanium Alloy (Ti6Al4V ELI) / Cobalt-Chromium-Molybdenum (CoCrMo) |
|
Kev kho saum npoo |
Titanium Plasma Spray (TPS), Hydroxyapatite (HA) Txheej, Porous Txheej, Grit-Blasted Finish |
|
Neck Taper Specifications |
Standard 12/14 Taper |
|
Caj dab-Ncej lub kaum sab xis xaiv |
125 degree, 130 degree, 135 degree |
|
Offset Configurations |
Standard Offset / High Offset (Lateralized) |
|
Ntsig Sizing Range |
Comprehensive progressive sizing (Qhov Loj 1 txog Qhov Loj 12+) |
|
Txoj Kev Sterilization |
Gamma Irradiation / Ethylene Oxide (EO) Sterilization |
|
Ntim raws tu qauv |
Muab ob npaug rau - txheej sterile blister ntim nrog tiv thaiv sab nrauv thawv |
|
Txoj Cai Ua Raws Cai |
ISO 13485 Certified, Ua raws li International Orthopedic Standards |
Advanced Engineering & Design Features
Biomechanically Optimized Geometry
- Proximally Wedged Profile: Txhawb nqa zoo heev "haum-thiab-sill" cov yam ntxwv nyob rau hauv lub femoral metaphysis, kom ntseeg tau tias tam sim ntawd rotational thiab axial stability.
- Optimized Load Distribution: Ua tau zoo hloov lub cev lub cev mus rau qhov sib thooj femur, tiv thaiv cov pob txha proximal resorption thiab khaws cia cov pob txha ib txwm muaj.
- Txo Kev Nyuaj Siab Shielding: Qhov kev loj hlob ntawm qhov nruab nrab taper txo cov qia txhav distally, txo qhov mob ntawm ncej puab thiab tiv thaiv kev ntxhov siab -shielding nyhuv.
- Restoration of Biomechanics: Ntau qhov kev xaiv offset tso cai rau cov kws phais kom rov tsim kho tus neeg mob lub cev femoral offset thiab ceg ntev yam tsis hloov lub caj dab.
Premium Implant Metallurgy
- Ti6Al4V ELI Titanium Alloy: Siv rau cementless stems vim nws tsis tshua muaj modulus elasticity (ze rau tib neeg cov pob txha), superior biocompatibility, thiab zoo heev qaug zog tiv thaiv nyob rau hauv cyclic physiological loading.
- CoCrMo Alloy: Tshwj xeeb tshaj yog cov neeg kho tshuab lub zog thiab hnav tsis kam, ua rau nws xaiv cov khoom siv zoo tshaj plaws rau cemented femoral stems thiab articulating Cheebtsam.
- Corrosion Resistance: Ob qho kev xaiv alloy tsim ib qho kev ruaj khov oxide zaj duab xis txheej, tiv thaiv fretting corrosion thiab ion tso tawm hauv vivo.
Biological Fixation Systems
- Hydroxyapatite (HA) Txheej: Ib txheej txheej biocompatible osteoconductive crystalline uas txhawb nqa kev ua haujlwm osteoblast sai thiab ceev cov pob txha anchorage.
- Titanium Plasma Spray (TPS): Tsim kom muaj kev ntxhib los mos ntawm micro- ntxhib nto profile uas ua rau kom muaj kev sib txhuam coefficient ntawm cov pob txha cog thiab tus tswv tsev rau cov xovxwm thawj zaug zoo tshaj - haum stability.
- Porous Structure: Features interconnected porosity optimized rau sib sib zog nqus trabecular pob txha ingrowth, ua tiav kev ruaj ntseg ntev - lub sij hawm thib ob lom kho.
Modular System Compatibility
- Standardized 12/14 Taper: Ua tau zoo nrog ntau yam ntawm femoral taub hau, nrog rau cov Ceramic Heads siab heev thiab siab -Nitrogen Cobalt-Chromium Heads.
- Versatile Configurations: Muaj nyob rau hauv Standard, High Offset, Short Stem, thiab Revision formats kom haum txig rau ntau yam anatomical configurations.
Clinical Indications
Peb cov kab ke femoral tau qhia rau kev siv hauv kev phais mob uas cov pob txha pob txha txaus los yog tuaj yeem ua kom ntxiv, tshwj xeeb rau:
Advanced Primary Osteoarthritis (OA) ntawm pob qij txha.
Mob Rheumatoid Arthritis (RA) cuam tshuam nrog kev sib koom ua ke deformity.
Avascular Necrosis (AVN) ntawm lub taub hau femoral.
Acute Femoral Neck Fractures xav tau kev sib koom ua ke.
Kev loj hlob Dysplasia ntawm Hip (DDH).
Tom qab-Taumatic Arthritis lossis post-Taumatic Joint Reconstruction.
Kho Arthroplasty rau kev ua tsis tau tejyam yav dhau los lub duav, aseptic loosening, los yog yam ntxwv instability.
Cov txheej txheem tsim khoom & Cleanroom Excellence
Txhua lub femoral qia implant yog tsim nyob rau hauv lub xeev - ntawm - lub - art kho mob manufacturing chaw siv tag nrho integrated, computer- tswj ntau lawm workflows:
Precision Forging & Machining:Advanced multi-axis CNC milling chaw txheej txheem kev kho mob-qib raw cov ntaub ntawv rau hauv cov khoom seem uas muaj qhov tshwj xeeb nruj heev.
Surface Texture Processing:Khoos phib tawj- tswj cov tshuaj plasma thiab grit- cov khoom siv blasting siv cov khoom sib xws, rov ua dua tshiab thiab cov txheej txheem bioactive.
Ultrasonic validation ntxuav:Ib tug multi-theem ultrasonic tu txheej txheem tshem tawm tag nrho cov microscopic manufacturing residue los lav qhov zoo pristine nto.
Laser Traceability Marking:Stems tau cim tas mus li nrog ntau tus lej tshwj xeeb, qhov ntau thiab tsawg, thiab cov lej cim kom paub meej tag nrho kev taug qab thoob plaws hauv lub neej cog qoob loo.
Cleanroom Ntim:Cov khoom lag luam raug kaw hauv kev kho mob- qib ob- txheej txheem ntim khoom tsis muaj menyuam nyob hauv Chav Kawm 10,000 (ISO 7) cov chav huv huv.
Quality Assurance & Regulatory Compliance
Kev ua tau zoo yog lub hauv paus ncej ntawm peb cov kev tsim khoom orthopedic. Peb tswj xyuas cov txheej txheem nruj me ntsis ntawm txhua theem ntawm kev tsim khoom kom ntseeg tau tias kev ua tiav tag nrho nrog cov qauv kev cai thoob ntiaj teb:
System Certification:Cov chaw tsim khoom ua haujlwm ua raws li ISO 13485 cov qauv kev tswj hwm kev kho mob zoo.
Raw Material Verification:Txhua batch ntawm Titanium thiab Cobalt -Chromium alloy tuaj txog nrog cov ntaub ntawv pov thawj cov ntaub ntawv pov thawj validating tshuaj muaj pes tsawg leeg thiab txhua yam khoom.
Dimensional soj ntsuam:Advanced Coordinate Measuring Machines (CMM) tshuaj xyuas cov tapers tseem ceeb, cov ces kaum, thiab qhov ntev kom ntseeg tau tias muaj tseeb ua raws li cov qauv tsim.
Coating Validation:Kev ntsuam xyuas tsis tu ncua, kev ntsuam xyuas lub zog tensile, thiab kev txheeb xyuas qhov porosity kom ntseeg tau cov qauv ntawm HA thiab TPS txheej.
OEM & ODM kev daws teeb meem
Peb muab cov kev cai tsim khoom thiab cov ntawv sau ntiag tug raws li lub ntiaj teb orthopedic hom, distributors, thiab cov koom haum muab khoom:
Kev cai Laser Marking:Kev koom ua ke ntawm koj lub logo uas muaj tswv, tus lej xov tooj, thiab cov cai tswj hwm hauv cheeb tsam ncaj qha mus rau qhov chaw cog qoob loo.
Tailored Branding & Ntim:Tsim kom muaj lub ntsej muag tsis muaj menyuam, ntim cov thawv sab hauv, thiab cov ntawv qhia kev qhia uas phim koj cov npe lag luam cov lus qhia.
Nto hloov kho Flexibility:Muaj peev xwm kho cov txheej thickness, roughness, thiab kev pab them nqi raws li koj cheeb tsam kev lag luam xav tau.
Surgical Instrumentation Development:Tsim thiab tsim khoom ntawm cov khoom siv kho kom haum, kev sim, thiab kev ua kom tsis muaj menyuam.
Cov ntaub ntawv txhawb nqa:Muab cov ntaub ntawv qhia txog kev ua haujlwm, daim ntawv pov thawj cov ntaub ntawv, thiab cov ntawv tshaj tawm siv tau los txhawb koj cov haujlwm sau npe hauv zos.
FAQ
Q: Hom kev kho deg twg muaj rau koj cov cementless femoral stems?
A: Peb muab ntau yam kev xaiv saum npoo raws li qhov yuav tsum tau ua hauv kev kho mob, suav nrog Titanium Plasma Spray (TPS), Hydroxyapatite (HA) txheej, thiab dual- txheej txheej (TPS ua ke nrog HA) kom xa ob qho tib si tam sim ntawd kev ruaj ntseg thiab ceev ceev ntev -lub sij hawm lom pob txha ingrowth.
Q: Cov ntaub ntawv dab tsi yog siv rau hauv koj cov cemented femoral qia configurations?
A: Peb cov cemented femoral stems feem ntau yog tsim los ntawm hwm Cobalt-Chromium-Molybdenum (CoCrMo) alloy, uas muab lub zog qaug zog thiab polished nto tiav yuav tsum tau sib txuas nrog cov pob txha kho mob.
Q: Puas yog koj cov femoral stems sib haum nrog thib peb - tog femoral taub hau?
A: Peb cov implants siv tus qauv, siab heev 12/14 caj dab taper configuration. Thaum lawv ua tau zoo nrog kev lag luam- tus qauv 12/14 ceramic thiab hlau femoral taub hau, peb pom zoo kom siv peb cov khoom siv lub taub hau zoo sib xws rau kev ua haujlwm zoo.
Q: Koj tuaj yeem lav qhov zoo thiab tsis muaj menyuam ntawm cov khoom cog thaum lub sijhawm xa khoom?
A: Txhua lub qia femoral tau ua tiav cov txheej txheem kom tsis muaj menyuam siv Gamma Irradiation lossis Ethylene Oxide. Cov khoom raug muab ntim rau hauv hnyav- lub luag haujlwm, ob npaug - cov hnab ntim khoom tsis muaj menyuam uas muaj kev tiv thaiv kev ncaj ncees thoob ntiaj teb kev thauj mus los thiab khaws cia.
Q: Dab tsi yog lub txee lub neej ntawm koj cov sterile ntim femoral stems?
A: Nyob rau hauv qhov chaw cia kom zoo (txias, qhuav, thiab tiv thaiv los ntawm tshav ntuj ncaj qha), peb cov sterile ntim implants tuav lub txee lub neej ntawm 5 xyoo txij li hnub ua kom tsis muaj menyuam.
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