Updated 22 October 2026
Orthopaedic and spine device distributors in Japan: 34 licensed establishments
The Bastion Hale Distributor Index lists 34 establishments in Japan whose registry records include orthopaedics, spine and trauma: 0 with a channel role (importer, distributor, wholesaler or authorised representative), 11 registration holders without a channel role, and 23 registered as manufacturer or exporter only, out of 526 medical device establishments in Japan overall. The records come from US FDA (openFDA) and Health Canada, last seen on 22 October 2026.
Orthopaedics covers implants for joints, spine and trauma, together with instruments and bone substitutes. Implants are usually Class IIb or III, so the importer or registration holder carries real regulatory work and hospitals often buy through tenders. Distributors in this segment tend to employ clinical support staff who attend surgery.
By role
| Role | Establishments | Share | What it means |
|---|---|---|---|
| Registration holder | 11 | 32% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 31 | 91% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 7 | 21% | Registered with the US FDA as an exporter of devices made for export. |
An establishment can hold several roles, so the shares add to more than 100%.
Who holds the registration in Japan
In Japan the marketing approval or certification is held by a Marketing Authorisation Holder (MAH) based in Japan, or by a Designated MAH acting for a foreign manufacturer. The foreign manufacturer registers separately with PMDA. An independent D-MAH keeps the approval out of the distributor's hands.
Top 20 orthopaedics, spine and trauma establishments by size
Channel roles first, then registration holders, then manufacturers. Size is a 0 to 100 score; Complete is 0 to 5.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | OLYMPUS MEDICAL SYSTEMS CORP. HACHIOJI-SHI Tokyo | Holder Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 351 | 183 | 0 | 71.2 | 3/5 |
| 2 | CANON INC. Kawasaki Kanagawa | Holder Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 673 | 107 | 0 | 70.4 | 3/5 |
| 3 | NAKANISHI INC. Kanuma Tochigi | Holder Registration holder, Manufacturer | Dental, Ear, nose and throat, Patient monitoring and neurology +2 more | 411 | 70 | 0 | 65.9 | 3/5 |
| 4 | FUJIFILM CORPORATION ASHIGARAKAMI-GUN Kanagawa | Holder Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Gastroenterology, urology and OB/GYN +4 more | 163 | 60 | 0 | 60.5 | 3/5 |
| 5 | KURARAY NORITAKE DENTAL INC. Kurashiki | Holder Registration holder, Manufacturer | Aesthetics, dermatology and lasers, General hospital and consumables, Dental +2 more | 258 | 50 | 0 | 58.6 | 3/5 |
| 6 | NIDEK CO., LTD. Gamagori | Holder Registration holder, Manufacturer | In-vitro diagnostics, Ophthalmic, Orthopaedics, spine and trauma +1 more | 113 | 45 | 0 | 54.0 | 3/5 |
| 7 | ITO COMPANY LIMITED Kawaguchi Saitama | Holder Registration holder, Manufacturer, Exporter | Patient monitoring and neurology, Orthopaedics, spine and trauma, Imaging, radiology and radiotherapy | 68 | 17 | 0 | 52.0 | 3/5 |
| 8 | NIHON KOHDEN CORPORATION SHINJUKU-KU Tokyo | Holder Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 92 | 8 | 0 | 48.6 | 3/5 |
| 9 | TSK LABORATORY, JAPAN TOCHIGI-SHI | Holder Registration holder, Manufacturer | General hospital and consumables, Orthopaedics, spine and trauma, Surgery and endoscopy | 10 | 9 | 0 | 38.3 | 3/5 |
| 10 | SEIRIN CORPORATION SHIZUOKA-SHI | Holder Registration holder, Manufacturer | General hospital and consumables, Patient monitoring and neurology, Orthopaedics, spine and trauma | 9 | 2 | 0 | 32.2 | 3/5 |
| 11 | OSFERIONBIOMATERIALS CORP. Tokyo | Holder Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Orthopaedics, spine and trauma | 2 | 1 | 0 | 20.8 | 3/5 |
| 12 | Nihon Kohden Corporation - Eastern Japan Logistics Center Sakado City Saitama | Manufacturer Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 64 | 1 | 0 | 34.1 | 3/5 |
| 13 | Nihon Kohden Corporation - Tokorozawa establishment Advanced Technology Center Tokorozawa Saitama | Manufacturer Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 58 | 1 | 0 | 33.6 | 3/5 |
| 14 | Arthrex Japan G.K. (Shinjuku) Shinjuku-ku Tokyo | Manufacturer Exporter | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +3 more | 46 | 1 | 0 | 32.4 | 3/5 |
| 15 | Zimmer Biomet G.K. Hiratsuka Kanagawa | Manufacturer Exporter | Orthopaedics, spine and trauma, Surgery and endoscopy | 38 | 1 | 0 | 31.5 | 3/5 |
| 16 | INAMI & CO., LTD. Bunkyo Tokyo | Manufacturer Manufacturer | General hospital and consumables, In-vitro diagnostics, Ophthalmic +2 more | 32 | 1 | 0 | 30.7 | 3/5 |
| 17 | KSI CO., LTD. Gotemba Shizuoka | Manufacturer Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 27 | 1 | 0 | 29.8 | 3/5 |
| 18 | DENTECH CORP. TOKYO | Manufacturer Manufacturer | Dental, Orthopaedics, spine and trauma, Surgery and endoscopy | 23 | 1 | 0 | 29.0 | 3/5 |
| 19 | KOGA ISOTOPE LTD. Koka-shi Shiga | Manufacturer Manufacturer | General hospital and consumables, Gastroenterology, urology and OB/GYN, In-vitro diagnostics +2 more | 19 | 1 | 0 | 28.1 | 3/5 |
| 20 | MEDMETALEX CO., LTD. Osaka | Manufacturer Manufacturer | Orthopaedics, spine and trauma, Surgery and endoscopy | 16 | 1 | 0 | 27.3 | 3/5 |
Questions about orthopaedics, spine and trauma distributors in Japan
How many orthopaedics, spine and trauma distributors are there in Japan?
The Index counts 34 establishments in Japan with orthopaedics, spine and trauma in their registry record, of which 0 hold a channel role as importer, distributor, wholesaler or authorised representative. The number comes from US FDA (openFDA) and Health Canada and was last refreshed on 22 October 2026.
Who can hold a orthopaedics, spine and trauma device registration in Japan?
In Japan the marketing approval or certification is held by a Marketing Authorisation Holder (MAH) based in Japan, or by a Designated MAH acting for a foreign manufacturer. The foreign manufacturer registers separately with PMDA. An independent D-MAH keeps the approval out of the distributor's hands.
How do I find a orthopaedics, spine and trauma distributor in Japan?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and Japan to reveal three profiles. For a ranked shortlist for your device, get the Next 10 Markets report.
What does the Distributor Index count as a orthopaedics, spine and trauma distributor in Japan?
A company that appears in a public regulatory registry with an address in Japan and whose linked device listings fall in the orthopaedics, spine and trauma segment, in any of the roles importer, distributor, wholesaler, authorised representative, registration holder, manufacturer or exporter. Each company is counted once.
Other segments in Japan
Orthopaedics, spine and trauma in other Asia Pacific markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 31 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 11 establishments, last seen 22 October 2026. Contains information licensed under the Open Government Licence, Canada.
Index build 22 October 2026. Each establishment is counted once per country after resolving names across sources. Named individuals are never collected.
Registry data. Bastion Hale does not vouch for any establishment.