Updated 22 October 2026
Orthopaedic and spine device distributors in the United States: 1,450 licensed establishments
The Bastion Hale Distributor Index lists 1,450 establishments in the United States whose registry records include orthopaedics, spine and trauma: 417 with a channel role (importer, distributor, wholesaler or authorised representative), 135 registration holders without a channel role, and 898 registered as manufacturer or exporter only, out of 9,881 medical device establishments in the United States 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 |
|---|---|---|---|
| Importer | 404 | 28% | Named as importer in a registry: EUDAMED importer, FDA initial importer, or a Gulf import licence. |
| Distributor | 43 | 3% | Holds a distribution licence or is listed as distributor (Health Canada MDEL, SFDA, Oman MOH). |
| Registration holder | 272 | 19% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 1,433 | 99% | Registered as a manufacturer with an address in this market, including foreign registrations. |
| Exporter | 148 | 10% | 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 the United States
In the United States the manufacturer registers its own establishment with the FDA and lists its devices; there is no local holder requirement. A US importer must also register as an initial importer, and the 510(k) or PMA stays in the manufacturer's name, so a distributor can be replaced without losing market access.
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 | Abbott Medical PLANO, TX | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 619 | 238 | 1 | 78.4 | 4/5 |
| 2 | Boston Scientific Corporation Coventry, RI | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 1196 | 411 | 0 | 78.2 | 3/5 |
| 3 | ZIMMER, INC. WARSAW, IN | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +5 more | 1316 | 240 | 0 | 78.2 | 3/5 |
| 4 | Covidien LLC North Haven, CT | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 959 | 338 | 0 | 78.0 | 3/5 |
| 5 | Conmed Corporation WESTBOROUGH, MA | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 911 | 201 | 0 | 77.7 | 3/5 |
| 6 | MEDTRONIC SOFAMOR DANEK USA, INC. Memphis, TN | Channel Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +9 more | 831 | 109 | 1 | 77.0 | 4/5 |
| 7 | ICU Medical, Inc. SOUTHINGTON, CT | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 1023 | 272 | 0 | 76.9 | 3/5 |
| 8 | HOWMEDICA OSTEONICS CORPORATION MAHWAH, NJ | Channel Importer, Registration holder, Manufacturer | Ear, nose and throat, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 901 | 104 | 1 | 76.0 | 4/5 |
| 9 | COOK, INCORPORATED ELLETTSVILLE, IN | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 791 | 150 | 0 | 75.6 | 3/5 |
| 10 | Teleflex Medical Inc. Morrisville, NC | Channel Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 858 | 99 | 1 | 75.5 | 4/5 |
| 11 | Becton, DIckinson and Company Cockeysville, MD | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 693 | 89 | 1 | 75.2 | 4/5 |
| 12 | SMITH & NEPHEW, INC. MEMPHIS, TN | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +5 more | 1710 | 97 | 0 | 74.8 | 3/5 |
| 13 | WRIGHT MEDICAL TECHNOLOGY, INC. Arlington, TN | Channel Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Ear, nose and throat, Patient monitoring and neurology +2 more | 685 | 76 | 1 | 74.4 | 4/5 |
| 14 | Bausch & Lomb Incorporated Manchester, MO | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 637 | 139 | 0 | 74.2 | 3/5 |
| 15 | MERIT MEDICAL SYSTEMS, INC. South Jordan, UT | Channel Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 537 | 165 | 0 | 74.1 | 3/5 |
| 16 | DEPUY ORTHOPAEDICS, INC. RAYNHAM, MA | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +8 more | 773 | 58 | 1 | 73.7 | 4/5 |
| 17 | ASPEN SURGICAL PRODUCTS, INC. Caledonia, MI | Channel Importer, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +10 more | 767 | 96 | 0 | 72.2 | 3/5 |
| 18 | KLS-Martin L.P. Jacksonville, FL | Channel Importer, Distributor, Registration holder, Manufacturer | Cardiovascular, General hospital and consumables, Dental +7 more | 561 | 52 | 1 | 71.6 | 4/5 |
| 19 | C.R. BARD, INC. COVINGTON, GA | Channel Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 769 | 58 | 0 | 71.1 | 3/5 |
| 20 | Bio-Rad Laboratories, Inc. IRVINE, CA | Channel Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, In-vitro diagnostics, Patient monitoring and neurology +1 more | 373 | 126 | 0 | 71.0 | 3/5 |
Questions about orthopaedics, spine and trauma distributors in the United States
How many orthopaedics, spine and trauma distributors are there in the United States?
The Index counts 1,450 establishments in the United States with orthopaedics, spine and trauma in their registry record, of which 417 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 the United States?
In the United States the manufacturer registers its own establishment with the FDA and lists its devices; there is no local holder requirement. A US importer must also register as an initial importer, and the 510(k) or PMA stays in the manufacturer's name, so a distributor can be replaced without losing market access.
How do I find a orthopaedics, spine and trauma distributor in the United States?
Open the top establishments on this page and check their roles, principals and registration counts. Then search the Index for your device and the United States 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 the United States?
A company that appears in a public regulatory registry with an address in the United States 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 the United States
Orthopaedics, spine and trauma in other North America markets
Sources
- US FDA Establishment Registration and Device Listing, openFDA bulk download: 1,413 establishments, last seen 22 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 289 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.