Emerging suppliers

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:

105

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
  • Components
  • Machinery and Equipment
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
  • Components
  • Fabrication Materials
  • Machinery and Equipment
CE, ISO10328, ISO9001

Camfore

(China) iii

Manufacturer of prostheses, focus on export Mainly Asia China
  • Components
  • Fabrication Materials
CE, FDA, ISO

Center for Assistive Technology

(India)

Manufacturer of P&O products, tools & machineries India and other emerging countries Bangalore, India
  • Components
  • Fabrication Materials
  • Machinery and Equipment
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
  • Components
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
  • Components
ISO 13485
106
Supplier (Country) Description LMIC Presence Manufacturing Sites Products Quality

DOI ortho- innovativ

(Germany)

Manufacturer of prosthetic products Asia, Africa, Middle East, South America Germany
  • Components
ISO 13485vi

e-life International

(Chinese Taipei)

Prostheses component supplier Asia, Africa, Middle Eastvii China
  • Components
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
  • Components
ISO 10328, CE

Fujian Guozi FPC

(China)

Leading Chinese prosthetic exporter Asia, Africa, Middle East Fujian, China
  • Components
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
  • Components
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
  • Components
  • Fabrication Materials
CE, ISO 13485
107
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
  • Components
  • Fabrication Materials
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
  • Components
  • Fabrication Materials
UK NHS supplier

Medex xi

(USA)

Prostheses supplier with a focus on lower-limb Information not available Information not available
  • Components
CE

Metiz xii

(Russia)

Prostheses manufacturer Asia, Africa, Middle East, South America. Countries include Iran, Sri Lanka, Mexico etc. Export to 24 countries
  • Components
  • Machinery and Equipment
ISO 9001, ISO 13485

MTO xiii

(Italy)

Produces and distributes semi-finished components for orthopaedics Worldwide distributor network Information not available
  • Components
ISO 9001

Mobility India (MI)

(India)

Designed and developed modular components in below knee prosthesis India and other emerging countries India
  • Components
  • Fabrication Materials
  • Machinery and Equipment
Information not available

Ortho-Europe

(UK)

Manufacturer of limb prostheses Information not available 7 manufacturing facilities across Europe
  • Components
  • Fabrication Materials
ISO 13485
108
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
  • Components
  • Fabrication Materials
  • Machinery and Equipment
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
  • Components
ISO 13485, ISO 9001

Proted

(Türkiye)

Prosthetic component supplier 80+ countries via global distributor network
  • Components
  • Machinery and Equipment
Information not available

Proactive Technical Orthopaedics xvi

(India)

Manufacturer of P&O products Distributor network and export to 30 countries Pune
  • Components
  • Fabrication Materials
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
  • Components
  • Fabrication Materials
ISO 13485, ISO 9001

Roadrunnerfoot xviii

(Italy)

Manufacturer of prostheses Africa, Southeast Asia Information not available
  • Components
  • Fabrication Materials
  • Machinery and Equipment
ISO 9001, ISO 13485, EU MDR
109
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.
  • Components
  • Fabrication Materials
  • Machinery and Equipment
Information not available

Shijiazhuang New Ausuo xix,xx

(China)

Prostheses ODM and OEM. ‘Ausuo’ is its own brand as well Targets LMICs (Asia, Africa, Middle East) Shijiazhuang, China
  • Components
  • Fabrication Materials
  • Machinery and Equipment
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
  • Components
CE, FDA, ISO

Shijiazhuang Wonderfu xxii

(China)

OEM/ODM for international brands; 15 years’ experience Southeast Asia, Africa, Middle East Shijiazhuang, China
  • Components
  • Machinery and Equipment
ISO 13485, CE

ST&G

(USA)

Lower limb prostheses company Distributors in 25+ countries: Asia, South America, Middle East Southern California
  • Components
  • Fabrication Materials
ISO 9001; experience with NGOs and government

Streifeneder xxiii

(Germany)

Supplier of prostheses components Asia, South America Germany
  • Components
  • Fabrication Materials
  • Machinery and Equipment
ISO 13485
110
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
  • Components
CE, FDA, ISO 9001, ISO 13485, EN 46001

Tehsen

(Chinese Taipei)

Manufacturer of prosthetic products Asia Information not available
  • Components
ISO 13485

Win Walker xxiv

(Chinese Taipei)

Prostheses manufacturer with office in China Information not available Information not available
  • Components
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/./. ↩︎

111