Trauma Implants OEM: Yadda Ake Kera Farantin Kulle Tibiofibular Distal Wanda Masu Rarraba Za Su Amince

Idan kai mai rarrabawa ne da ke kimanta abokin tarayya na Trauma Implants OEM, mafi wahala ba shine samun masana'anta da ke iya injin faranti ba..

Yana nemo wanda zai iya kera hadadden farantin kulle jikin mutum akai-akai, rubuta shi cikin tsafta, da jigilar shi cikin dogaro - ba tare da 'mamaki' ba lokacin da kuka fara rajista, tayi, ko prep.

Wannan sakon ya rushe abin da 'mai kyau' yayi kama da yin amfani da farantin kulle tibiofibular mai nisa (sau da yawa ana haɗa shi tare da iyalai masu kulle fibula / ƙafar ƙafar ƙafa) a matsayin misali mai gudana-saboda yana haɗa murfin nama mai laushi na bakin ciki, juriya mai ƙarfi, da ƙimar kulle-rami ta hanyar da sauri ke fallasa tsarin masana'anta mara ƙarfi.

Mabuɗin ɗaukar hoto

• A 'cikakkun' farantin makullin tibiofibular nesa ba game da ikirarin tallace-tallace ba ne. Yana game da dacewa, ingancin mu'amalar kulle-kulle, sarrafa haɗarin gajiya, da ganowa.

• Ya kamata mai samar da ku ya iya yin bayani (da takarda) yadda suke sarrafa TC4 titanium (Ti-6Al-4V) , machining, kammalawa, tsaftacewa, da dubawa-yawanci bayan kuri'a.

• Don kasuwannin duniya, alamar Laser + zanen ganowa ta UDI da marufi mai tsabta ba su da kyau a samu — su ne tushen asali.

• Idan kuna son motsawa da sauri, saiti 10 mai wuya MOQ na iya zama mai ƙarfi mafi ƙarfi don isa ga samfuran da PO na farko ba tare da ɗaukar haɗarin da ba a yarda da shi ba.

Abin da farantin makullin tibiofibular mai nisa yana buƙatar yi (a cikin Ingilishi a sarari)

Yi tunanin farantin kulle kamar madaidaicin samfurin 'interface.' Farantin yana da mahimmanci-amma farantin + screw interface shine ainihin tsarin.

Shi ya sa manyan tsarin farantin idon kafa/fibula suna jaddada fasalulluka kamar ƙananan faranti na titanium , da aka haɗa da sifofin anatomically , da zaɓuɓɓukan kullewa na ci gaba da aka tsara don inganta gyarawa yayin da rage haushin nama mai laushi (duba bayyani na Zimmer Biomet na ALPS Fibula Plating System).

Lokacin da kuka ji 'distal tibiofibular locking plate,' yawanci kuna kimanta dangin farantin da ke buƙatar isar da abubuwa guda huɗu akai-akai-musamman idan kuna yin nunin na'ura mai ƙira ta tibiofibular makullin farantin nesa don shirin lakabin sirri:

1) Kwakwalwar halitta wanda ya dace ba tare da lankwasawa ba

'Anatomically contoured' ba da'awar da ba ta dace ba - gwajin maimaitawa ne.

Idan daidaiton kwane-kwane ya canza tsakanin kuri'a, kuna samun matsalolin ƙasa: tsayi KO lokaci, gunaguni na nama, rashin daidaituwar faranti, da mafi girma komowa / haɗarin koke.

Maɓallin Takeaway : Don irin wannan farantin karfe, makasudin masana'anta ba shine 'za ku iya yin shi sau ɗaya?' ' Shin za ku iya riƙe kwandon kowane lokaci?'

Don ganin yadda manyan tsare-tsare suka bayyana wannan buƙatu, Zimmer Biomet a sarari ya sanya tsarin ALPS Fibula Plating System a kusa da ƙananan bayanan martaba, hanyoyin magance fibula na zahiri.

2) Ƙananan bayanan martaba, saboda murfin nama mai laushi yana da iyaka

Yankunan fibula / idon sawu suna da ƙarancin ɗaukar hoto. 'Ƙananan bayanan martaba' yawanci shine ainihin abin da ake buƙata a ƙira a cikin yaren tsarin (sake, duba 'ƙananan bayanan martaba' a cikin Zimmer Biomet ALPS fibula system page).

Daga hangen nesa na OEM, ƙananan ƙirar ƙira suna haɓaka wahalar masana'antu saboda gefuna, radis, da lahani na ƙarshe sun zama mafi bayyane a asibiti kuma suna iya haifar da gunaguni.

3) Rukunin kullewa mai nisa wanda ke ɗaukar ƙananan guntu

Yawancin iyalai na nesa na fibula suna amfani da gungu mai nisa mai yawa. Misali mai amfani na yadda aka kwatanta wannan a kasuwa shine bayanin Orthobullets na farantin fibula mai nisa da ke nuna gungun ramuka mai nisa 7' wanda ke karɓar ƙulle-ƙulle mai canzawa kuma yana jaddada rage fushi yayin ɗaukar gutsuttsura (duba Pangea Distal Lateral Fibula plate page).

4) Ingancin kulle-kulle (saboda 'kulle' ba ya gafartawa)

Makulle ramukan tattara haɗarin masana'antu:

• thread form da surface mutunci

• daidaitaccen kusurwa na trajectories

• iko iko

• maimaitawa cikin kayan aiki da batches

Ga masu rarrabawa, wannan yana fassara zuwa tambaya guda ɗaya:

Pro Tukwici : Tambayi OEM yadda suke tabbatar da ingancin kulle-rami- ba kawai girma ba , amma aikin dubawa, sarrafa kayan aiki, da ma'aunin yarda.

Trauma Implants OEM masana'anta kwarara ('daidaitacce' jeri)

Abokin haɗin gwiwa mai ƙarfi na Trauma Implants OEM na iya bi da ku ta cikakkiyar masana'anta da fitarwa ba tare da fakewa a bayan tallace-tallacen ba.

A ƙasa akwai jerin ayyuka da yakamata ku yi tsammani don hadadden farantin kulle titanium.

(Idan kun kasance sababbi ga tantancewar mai siyarwa, wannan sashin ana nufin ninka shi azaman bayyani-Turanci bayyananne na masana'antar OEM da ke haifar da rauni ta orthopedic .)

Mataki na 1: Fara da titanium mai dacewa daidai (TC4 / Ti-6Al-4V)

Don faranti na rauni, titanium-sa-sasa shi ne tsoho don yawancin tsarin; misali, Zimmer Biomet a sarari ya lissafa kayan faranti kamar 'Ti-6Al-4V ELI' don ALPS fibula plates.

MOQ ɗin ku, lokacin jagora, da farashin ba su da matsala idan OEM ba za ta iya sarrafawa ba:

• takaddun shaida na kayan aiki da ganowa da yawa

• ilmin sunadarai / kayan aikin injiniya

• dubawa mai shigowa da rarrabuwa

Ba za a iya sasantawa ba don wannan shirin: dole ne a sanya abubuwan da aka sanyawa a matsayin TC4 titanium (Ti-6Al-4V) darajar likita.

Idan kana amfani da wannan farantin a matsayin ma'auni, bayyana shi a sarari a cikin abubuwan da kake buƙata: kana samo shirin Ti-6Al-4V (TC4) titanium locking shirin, ba madadin 'titanium-like' ba.

Mataki 2: Daidaitaccen mashin ɗin CNC wanda ke mutunta tsarin jiki da musaya na kullewa

Geometry na Anatomic plate tare da ingancin kulle-rami shine inda iyawar ta nuna.

Yaya 'mai kyau' yayi kama:

• barga, ingantattun hanyoyin injina don mahimman fasali (ramukan kullewa, gungu mai nisa, filayen kwandon faranti)

• saka idanu kayan aiki mai sarrafa kayan aiki don guje wa faɗuwa

• abubuwan da za a iya maimaitawa (don haka tarin ya zama iri ɗaya a cikin kuri'a)

Wannan kuma shine inda iƙirarin da'' ''za mu iya yin 5-axis'' da'awar ya zama abin aunawa: inji, kayan aiki, da tsare-tsaren dubawa waɗanda ke nuna maimaitawa-ba jerin kayan aiki kawai ba.

Mataki na 3: Ƙarfafawa da ƙare baki sune gajiya da sarrafa ƙararraki

Don ƙananan faranti, kammalawa ba kayan kwalliya ba ne. Yana shafar:

• haushin nama mai laushi (complaints)

• hadarin barbashi

• gajiya aiki (micro-notches iya kome)

Tambaya don gani:

• kammala ka'idojin yarda

• ka'idojin dubawa na gani

• samfurin lahani hotuna da ka'idojin rarrabawa

Mataki na 4: Tsaftacewa da sarrafa gurɓatawa kafin shiryawa

OEM tabbatacce ya kamata su iya yin bayanin sarrafa tsaftacewa (kuma, inda ya dace, tsarin tabbatarwa) ta hanyar da ta wuce bincike na asali.

Abin da kuke kula da shi azaman mai rarrabawa:

• ragowar (mai sanyaya, mai) da ɓangarorin ba 'kananan matsalolin' ba ne a cikin rajista da tantancewa.

• tsaftacewa da kulawa ya kamata su goyi bayan ingancin marufi

Mataki na 5: Dubawa, gwaji, da tunani 'mafi muni'.

Ko da a matakin TOFU, yana da daraja fahimtar ra'ayi ɗaya na ƙa'ida saboda yana motsa yadda manyan masu samar da kayayyaki ke tunani:

Jagorar FDA don faranti na gyaran karaya na kasusuwa yana jaddada zabar faranti mafi muni ga kowane yanki na jiki don gwajin injina (duba FDA PDF Orthopedic Fracture Fixation Plates guide).

Ba kwa buƙatar zama dakin gwaje-gwaje don amfani da wannan hangen nesa. Kawai kuna buƙatar tambaya:

• 'Wanne tsari ne mafi munin shari'arku ga wannan dangin faranti-kuma me yasa?''

• 'Wace shaida kuke da ita kan wannan mugun hali?'

Gargaɗi : Idan mai siyarwa ya nuna samfurin 'kyakkyawan kyan gani' guda ɗaya kawai kuma ba zai iya yin bayanin zaɓi mafi muni ba, ɗauki wannan azaman tuta mai balagagge.

Bukatun shirye-shiryen kasuwa waɗanda bai kamata masu rarraba su yi sulhu akai ba

Alamar Laser + UDI zane-zane

Don manyan kasuwanni masu yarda, kuna son masana'anta su goyi bayan:

• Likita-sa Laser marking

• cikakken UDI lambar zanen ganowa

A cikin sharuddan aiki, wannan UDI Laser alama ce ta ƙwanƙwasa ƙwanƙwasa ƙaƙƙarfan buƙatu: ikon yin alama da gano na'urori akai-akai, a zahiri, da kuma tantancewa.

Wannan ba alama ce kawai ba - yana da sarrafa sarkar wadata. Yana ɗaure ƙorafin ku kuma yana komawa zuwa yawan samarwa kuma, a ƙarshe, zuwa yawan albarkatun ƙasa.

Marufi mai tsaftataccen ɗaki + Gudanar da haifuwar Gamma/EO

Ko samfurin ƙarshe an aika bakararre ko marassa bakararre, ƙarfin OEM yakamata ya haɗa da:

• marufi mai tsaftataccen ɗaki (rufe, mai karewa, daidaito)

• sarrafa Gamma/EO Ƙarfin

Wannan shine bambanci tsakanin 'zamu iya jigilar sassa' da 'zamu iya tallafawa shirin dasa.'

TS EN ISO 13485 + CE - da tallafin lissafin don kasuwannin LATAM

Takaddun shaida ba taken ba ne. Tambayar mai rarraba ita ce: OEM na iya tallafawa takaddun takarda da horo da ake buƙata don shiga kasuwa?

Aƙalla, wannan shirin ya kamata a ɗaure shi da:

• TS EN ISO 13485 ingancin tsarin tsammanin

• Tsarin takaddun shaida na CE

Kuma don makasudin LATAM, OEM ɗinku yakamata su kasance cikin shiri don tallafawa takaddun fasaha na rajista azaman daidaitaccen ɓangaren haɗin gwiwa.

Lever kasuwanci mafi yawan OEMs marasa amfani: mai wuya 10 ya saita MOQ

Idan kuna gina sabon layi ko gwada sabon OEM, abubuwan saurin gudu.

Tsayayyen saiti 10 MOQ ba tayin kasuwanci bane kawai - kayan aikin sarrafa haɗari ne:

• za ku iya kimanta dacewa / gamawa / yin alama / marufi da wuri

• za ku iya tabbatar da ayyukan aiki na takardu kafin yin babban kaya

• za ku iya rage hanya zuwa saitin kima na farko ko likitan fiɗa

Idan kuna son fahimtar yadda ƙaramin MOQ ke haɓaka umarni na farko, wannan jagorar na ciki yana da amfani mai amfani: Kaddamar Your Orthopedic Brand tare da 10-Set MOQ.

Jerin abubuwan dubawa na OEM masu rarrabawa (abin da za a tambaya kafin yin samfur)

Ci gaba da sauƙi. Kafin ka nemi samfurori don shirin kulle tibiofibular na nesa, nemi:

1. Bayanin kayan aiki : TC4 titanium (Ti-6Al-4V) + takaddun takaddun kayan misali

2. Samfurin ganowa : misali na ƙididdige ƙima + aikin UDI + hotuna samfurin alamar laser

3. Bayanin masana'anta : machining + gamawa + tsaftacewa + kwararar dubawa (shafi ɗaya)

4. Shaidar dubawa : jeri mai mahimmanci + yadda ake tabbatar da ingancin kulle-rami

5. Zaɓuɓɓukan marufi : samfurin marufi mai tsafta da ƙayyadaddun bayanai

6. Gudanar da Haifuwa : Bayanin iyawar Gamma/EO (ikon, sarrafawa)

7. Takaddun shaida : ISO 13485 da CE takaddun shaida + Bayanin iyaka

8. Tallafin lissafin LATAM : jerin takaddun da aka saba bayarwa don rajista

Don ƙarin tambayoyin sayayya za ku iya sake amfani da su a cikin tsarin rauni, duba: Tambayoyi 10 Masu Rarraba Orthopedic Suke Yi Lokacin Samar da Masu Bayar da Rarraba Rarraba.

FAQ

1) Menene MOQ ɗin ku don shirin kulle tibiofibular mai nisa?

Don yawancin ingantattun jagorancin masu rarrabawa, saiti 10 MOQ wuri ne mai amfani saboda yana ba ku damar yin bitar dacewa / gamawa, keɓancewar ramuka, yin alama, da takaddun bayanai kafin yin babban ƙira. Idan kuna buƙatar tsarin samfuri daban-daban (misali, saitin hagu/dama, tsayin tsayin daka), daidaita madaidaicin lissafin daidaitawa a rubuce kafin PO na farko.

2) Menene kuke buƙata daga gare mu don fara samfurori da sauri?

Don tafiya da sauri ba tare da ingantattun abubuwan mamaki ba, shirya:

• zane ko takardar ƙayyadaddun samfur (ko jerin dangin farantin da kuke so)

• Kasuwar (s) da aka yi niyya da hanyar rajista (misali CE, buƙatun LATAM na gida)

• Bukatun lakabi / ganowa (lambar kuri'a, UDI, harshe)

Sa'an nan OEM ya kamata tabbatar da: jagorar lokaci , m girma , tsarin dubawa , da abin da za a bayar a cikin samfurin fakitin (certs, rahotanni, hotuna).

3) Menene darajar titanium yakamata mu saka wa waɗannan faranti?

Don irin wannan nau'in farantin rauni, ƙididdige TC4 titanium (Ti-6Al-4V) tare da cikakkun buƙatu don takaddun shaida, ganowa da yawa, da sarrafawar dubawa mai shigowa. Idan kuna da fifiko don darajar ELI (wanda aka fi sani da shi a kasuwa), bayyana shi a sarari a matakin RFQ don OEM na iya daidaita abubuwan da ake samu da takaddun shaida.

4) Waɗanne takaddun shaida ne suka fi mahimmanci yayin zabar Trauma Implants OEM?

Aƙalla, yakamata ku yi tsammanin tsarin kula da ingancin ingancin ISO 13485 wanda ke rufe iyakokin da suka dace (shigar da / ko kayan aiki). Ga kasuwanni da yawa, horon takaddun takaddun CE shima yana da mahimmanci. Idan kuna niyya ga Amurka, lura cewa FDA 510k takamaiman samfuri ne , don haka tambayi yadda OEM ke goyan bayan fakitin ƙaddamar da ku (misali, goyan bayan gwaji, ganowa, da shirye-shiryen takardu) maimakon ɗaukan masana'anta 510k.

5) Ta yaya za mu tabbatar da ingancin kulle-rami fiye da sauƙi mai sauƙi?

Nemi shaidar cewa mai siyarwar yana sarrafa maɓallan kullewa azaman tsari, gami da:

• duba fasali masu mahimmanci (siffar zaren, daidaiton saman, yanayi/kwasa)

• saka idanu kayan aiki da ka'idojin yarda

• go/no-go ko duba aikin dubawa inda ya dace

Har ila yau a nemi bayanan binciken samfurin da ƙayyadaddun ƙayyadaddun ƙayyadaddun lahani don burrs, lalata zaren, da lahani na saman.

6) Wadanne takardun dubawa ya kamata su zo tare da samfurori?

Ƙaƙƙarfan fakitin samfurin yawanci ya haɗa da:

• misalan takaddun shaida na kayan aiki da bayanin ganowa da yawa

• rahoton binciken ma'auni mai mahimmanci (tare da auna sakamako, ba jerin abubuwan dubawa kawai ba)

• hotuna na gungu na kulle-rami da gefuna da aka gama

• misalan alamar alama / gano idan an buƙata (lambar yawa, aikin UDI)

Idan OEM ba za ta iya samar da waɗannan don samfurori ba, alama ce ta duban ku na farko na iya zama da wahala fiye da buƙata.

Matakai na gaba

Idan kuna kimanta abokan hulɗar Trauma Implants OEM kuma kuna son daidaita binciken ku na ciki, gina kan wannan babban albarkatu: Ƙarshen Jagora: Maƙerin Kulle Faranti.

Kuna son lissafin shirye-shiryen kwafi? Amsa tare da kasuwar da aka yi niyya (US-kawai vs US + LATAM) kuma zan tsara wannan zuwa takaddar ƙimar OEM mai shafi ɗaya da zaku iya rabawa tare da ƙungiyar ku.

Ɗayan ƙarin albarkatun da ke da alaƙa (idan kuna gina cikakken layin rauni): Masu Bayar da Rarraba Rarraba Rarraba Rarraba.