Manufacturers have emerged, mainly in Mexico, Türkiye, China, and India (see table 46). They offered lower-priced options suited for LMICs contexts. Many of these suppliers have obtained internationally recognized certificates of quality, including ISO conformity, approved by the US FDA and the European Commission (CE marking). Small companies like Camfore and Aosuo concentrate on LMIC markets by producing generics (i.e. copies of components developed decades ago, now free from IP protection), or strive to develop innovative products and services with competitive pricing for the broader market, exemplified by companies like ST&G.
Emerging manufacturers make products classified into three categories:
Table 46: Emerging prostheses suppliers
Supplier (Country) | Description | LMIC Presence | Manufacturing Sites | Products | Quality |
---|---|---|---|---|---|
ALIMCO i (India) |
NGO under the Ministry of Social Justice and Empowerment. It has helped establish 170 Limb Fitting Centres in India | India and export experience in Afghanistan, Angola, Bangladesh, Cambodia, Nepal, Jordan, Iraq, Sri Lanka, United Arab Emirates, Uzbekistan etc. | India |
|
ISO 9001 |
Beijing Jingbo (China) |
Leading prostheses supplier in China | 40+ countries globally, including Africa and Asia | China Annual capacity: - 100,000 prosthetic parts - 20,000 prosthetic jointsii |
|
CE, ISO10328, ISO9001 |
Camfore (China) iii |
Manufacturer of prostheses, focus on export | Mainly Asia | China |
|
CE, FDA, ISO |
Center for Assistive Technology (India) |
Manufacturer of P&O products, tools & machineries | India and other emerging countries | Bangalore, India |
|
Information not available |
Circleg (Switzerland) iv |
Supplier of polycentric knee, dynamic foot, pylon and cover for LMICs market |
Supply across LMICs. Kenya is the hub for supplying African continent |
Nairobi Kenya and Zurich Switzerland |
|
CE, ISO 10328, EU MDR |
College Park (USA) |
Prostheses supplier since 1988, acquired by Ossur in 2020 | 50+ countries including countries in Asia, Africa, Middle Eastv | USA |
|
ISO 13485 |
Supplier (Country) | Description | LMIC Presence | Manufacturing Sites | Products | Quality |
---|---|---|---|---|---|
DOI ortho- innovativ (Germany) |
Manufacturer of prosthetic products | Asia, Africa, Middle East, South America | Germany |
|
ISO 13485vi |
e-life International (Chinese Taipei) |
Prostheses component supplier | Asia, Africa, Middle Eastvii | China |
|
ISO 13485, FDA, EU MDRviii |
EXONEO ix (France) |
Innovative start-up | South America, Asia and Africa etc. Countries include Algeria, Egypt, Ghana, India, Iraq, Jordan, Lebanon, Morocco, Myanmar, Nigeria, Pakistan, Palestine, Togo, Tunisia, Viet Nam, and Zimbabwe. | Parts of the products are manufactured in Tunisia, Austria and France and assemble or pre-assemble in France |
|
ISO 10328, CE |
Fujian Guozi FPC (China) |
Leading Chinese prosthetic exporter | Asia, Africa, Middle East | Fujian, China |
|
CE, FDA, ISO 9001x |
GO Assistive Technology (UK) |
Innovative start-up | Tanzania, Rwanda, South Africa, Cambodia, Nepal. More distributors in pipeline for Africa and Asia. | South Africa, Switzerland |
|
CE (In progress, planned for June 2024) |
Hua Kang Pros (Hong Kong SAR) |
Component manufacturer | Eastern Asia, Southeast Asia, Middle East, Africa, South America | Information not available |
|
CE, ISO 13485 |
Supplier (Country) | Description | LMIC Presence | Manufacturing Sites | Products | Quality |
---|---|---|---|---|---|
IB-ER Prosthetics (Türkiye) |
Manufacturer of lower-limb components | Asia, Africa, South America. Countries include Syria, Iraq etc. Sales in 40+ countries | Manisa City, Türkiye |
|
CE, FDA, ISO 13485, ISO 9001, fulfilled Medical Device Regulation 2017/745 |
Limbtex (UK) |
Manufacturer of prostheses materials | Worldwide distributor network | South Wigston, Leicestershire, East Midland, UK |
|
UK NHS supplier |
Medex xi (USA) |
Prostheses supplier with a focus on lower-limb | Information not available | Information not available |
|
CE |
Metiz xii (Russia) |
Prostheses manufacturer | Asia, Africa, Middle East, South America. Countries include Iran, Sri Lanka, Mexico etc. Export to 24 countries |
|
ISO 9001, ISO 13485 | |
MTO xiii (Italy) |
Produces and distributes semi-finished components for orthopaedics | Worldwide distributor network | Information not available |
|
ISO 9001 |
Mobility India (MI) (India) |
Designed and developed modular components in below knee prosthesis | India and other emerging countries | India |
|
Information not available |
Ortho-Europe (UK) |
Manufacturer of limb prostheses | Information not available | 7 manufacturing facilities across Europe |
|
ISO 13485 |
Supplier (Country) | Description | LMIC Presence | Manufacturing Sites | Products | Quality |
---|---|---|---|---|---|
Ortotek xiv (Türkiye) |
Manufacturer and distributor of prosthetic products | Africa, Middle East. Export in 55 countries | Ankara |
|
ISO 9001, ISO 13485, TS 12426, TS 13181 |
Ortpar xv (Türkiye) |
Manufacturer of over 30 different prosthetic parts and devices | Africa, Asia, Middle East. Countries include India, Lebanon etc. | Türkiye |
|
ISO 13485, ISO 9001 |
Proted (Türkiye) |
Prosthetic component supplier | 80+ countries via global distributor network |
|
Information not available | |
Proactive Technical Orthopaedics xvi (India) |
Manufacturer of P&O products | Distributor network and export to 30 countries | Pune |
|
CE, ISO 10328, ISO 9001 |
Regal Prostheses xvii (Hong Kong SAR) |
Manufacturer of a range of prostheses products | Asia, Africa, South America | Information not available |
|
ISO 13485, ISO 9001 |
Roadrunnerfoot xviii (Italy) |
Manufacturer of prostheses | Africa, Southeast Asia | Information not available |
|
ISO 9001, ISO 13485, EU MDR |
Supplier (Country) | Description | LMIC Presence | Manufacturing Sites | Products | Quality |
---|---|---|---|---|---|
Re-life (Canada) |
The company covers prosthetic products including lower limb and upper limb components, joint bar systems components, raw material, machinery and equipment | Middle East such as Iraq, Lebanon, Syria | USA, Canada, China, Korea, Germany etc. |
|
Information not available |
(China) |
Prostheses ODM and OEM. ‘Ausuo’ is its own brand as well | Targets LMICs (Asia, Africa, Middle East) | Shijiazhuang, China |
|
CE, ISO 13485, ISO 9001 |
Shijiazhuang Perfect xxi (China) |
Mainly lower limb components | Sales in more than 50 countries in Southeast Asia, South America | Shijiazhuang, China |
|
CE, FDA, ISO |
Shijiazhuang Wonderfu xxii (China) |
OEM/ODM for international brands; 15 years’ experience | Southeast Asia, Africa, Middle East | Shijiazhuang, China |
|
ISO 13485, CE |
ST&G (USA) |
Lower limb prostheses company | Distributors in 25+ countries: Asia, South America, Middle East | Southern California |
|
ISO 9001; experience with NGOs and government |
Streifeneder xxiii (Germany) |
Supplier of prostheses components | Asia, South America | Germany |
|
ISO 13485 |
Supplier (Country) | Description | LMIC Presence | Manufacturing Sites | Products | Quality |
---|---|---|---|---|---|
Teh Lin (Chinese Taipei) |
Customized solutions for all levels of amputation with 50+ years’ experience | Asia, South America. Globally serves 50+ countries | Chinese Taipei |
|
CE, FDA, ISO 9001, ISO 13485, EN 46001 |
Tehsen (Chinese Taipei) |
Manufacturer of prosthetic products | Asia | Information not available |
|
ISO 13485 |
Win Walker xxiv (Chinese Taipei) |
Prostheses manufacturer with office in China | Information not available | Information not available |
|
CE, ISO 13485, ISO 9001 |
iPunarbhava official website, https://punarbhava.in/index.php/resources/institutions/ministry-of-social- justice-and-empowerment/alimco. ↩︎
iiProduction R&D, 2018, Beijing Jingbo, http://www.jingbo-po.com/index.php/Article/detail?id=9. ↩︎
iiiInformation provided by Camfore. ↩︎
ivInformation provided by Circleg. ↩︎
vCollege Park official website, https://www.college-park.com/resources/international/. ↩︎
viDOI ortho-innovativ GmbH official website, https://www.ortho-innovativ.de/en-gb/home. /.↩︎
vii e-life distributors, https://www.e-lifebracing.com/distributors.php. /. ↩︎
viii e-life history, https://www.e-lifebracing.com/about-history.php /. ↩︎
ixInformation provided by EXONEO. /.↩︎
xFujian Guozi Rehabilitation Medical company official website, http://www.fpcfoot.com/article/about/gsgk. shtml. /. ↩︎
xiMedex company official website, https://www.medexinternational.com/about.cfm. /. ↩︎
xii Metiz company official website, https://metiz-ltd.com/./. ↩︎
xiii M.T.O S.p.A official website, https://www.mto.it/./. ↩︎
xivOrtotek company official website, https://www.ortotek.com/en. /. ↩︎
xvOrtpar Orthopedics company official website, https://www.ortpar.com/contact.html. /. ↩︎
xviProactive Technical Orthopaedics company official website, https://www.protechortho.com/./. ↩︎
xvii Regal prosthesis official company website, https://regalprosthesis.com/web/./. ↩︎
xviii Roadrunnerfoot Engineering company official website, https://www.roadrunnerfoot.com/about-us/. /. ↩︎
xix Aosuo company official website, https://m.as-health.cn/intro/About-us-1.html. /. ↩︎
xx Information provided by Aosuo. /.↩︎
xxi Shijiazhuang Perfect Prosthetic Manufacture company official website, https://www.sjzpfc.com/./. ↩︎
xxii Shijiazhuang Wonderfu Alibaba official website, https://wonderful-reha.en.alibaba.com/company_profile. html?spm=a2700.shop_index.88.34. /. ↩︎
xxiii Streifeneder ortho.production GmbH company official website, https://www.streifeneder.com/op/company/ profile. /. ↩︎
xxiv Win Walker company official website, http://www.win-walker.com/./. ↩︎