Updated 22 October 2026
Orthopaedic and spine device distributors in the United States: 1,453 licensed establishments
The Bastion Hale Distributor Index lists 1,453 establishments in the United States whose registry records include orthopaedics, spine and trauma: 4 independent distributors (a channel role such as importer, distributor, wholesaler or authorised representative, and no manufacturing of their own), 412 manufacturers' own import or sales entities, 1 regulatory representatives, and 1,036 manufacturers or exporters, out of 10,187 medical device establishments in the United States overall. The records come from US FDA (openFDA), Health Canada and MHRA UK, last seen on 23 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 | 273 | 19% | Holds device licences or registrations in its own name (Health Canada MDALL licence holder). |
| Manufacturer | 1,436 | 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 4 independent orthopaedics, spine and trauma distributors
Independent distributors only, ranked by the other manufacturers' lines they carry, then registrations held, then size.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | MAXMORESPINE San Diego, CA | Distributor Importer | Anaesthesia and respiratory, General hospital and consumables, Dental +3 more | 36 | 1 | 0 | 31.2 | 3/5 |
| 2 | VERITAS MEDICAL DEVICES LLC Southlake, TX | Distributor Importer | Orthopaedics, spine and trauma | 6 | 1 | 0 | 22.8 | 3/5 |
| 3 | GALDERMA LABORATORIES, L.P. Fort Worth, TX | Distributor Importer | Aesthetics, dermatology and lasers, General hospital and consumables, Orthopaedics, spine and trauma +1 more | 5 | 1 | 0 | 22.0 | 3/5 |
| 4 | REVANCE THERAPEUTICS, INC. Newark, CA | Distributor Importer | Aesthetics, dermatology and lasers, Orthopaedics, spine and trauma | 1 | 1 | 0 | 16.5 | 3/5 |
Include manufacturers, their own sales entities and regulatory representatives (1,449)
Manufacturers, companies that are a manufacturer's own import or sales arm, and regulatory representatives (authorised representatives, sponsors or registration holders with no import or distribution role). They are registered here but are not independent distributors.
| # | Establishment | Roles | Segments | Products | Registrations | Principals | Size | Complete |
|---|---|---|---|---|---|---|---|---|
| 1 | Boston Scientific Corporation Coventry, RI | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 1196 | 520 | 0 | 80.6 | 3/5 |
| 2 | Covidien LLC North Haven, CT | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 959 | 454 | 0 | 80.4 | 3/5 |
| 3 | ICU Medical, Inc. SOUTHINGTON, CT | Maker's own entity Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 1023 | 353 | 0 | 79.3 | 3/5 |
| 4 | Abbott Medical PLANO, TX | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 619 | 299 | 1 | 80.8 | 4/5 |
| 5 | ZIMMER, INC. WARSAW, IN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Dental +5 more | 1316 | 249 | 0 | 80.6 | 3/5 |
| 6 | HOLOGIC, INC. Marlborough, MA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +6 more | 305 | 245 | 0 | 74.6 | 3/5 |
| 7 | Conmed Corporation WESTBOROUGH, MA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +7 more | 911 | 222 | 0 | 80.1 | 3/5 |
| 8 | Becton, DIckinson and Company Cockeysville, MD | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +8 more | 693 | 204 | 1 | 81.4 | 4/5 |
| 9 | COOK, INCORPORATED ELLETTSVILLE, IN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 791 | 202 | 0 | 79.4 | 3/5 |
| 10 | MERIT MEDICAL SYSTEMS, INC. South Jordan, UT | Maker's own entity Distributor, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +8 more | 537 | 199 | 0 | 77.4 | 3/5 |
| 11 | Bausch & Lomb Incorporated Manchester, MO | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 637 | 151 | 0 | 77.0 | 3/5 |
| 12 | Bio-Rad Laboratories, Inc. IRVINE, CA | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, In-vitro diagnostics, Patient monitoring and neurology +1 more | 373 | 143 | 0 | 74.0 | 3/5 |
| 13 | Smith & Nephew, Inc., MEMPHIS, TN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Anaesthesia and respiratory, General hospital and consumables, Ear, nose and throat +5 more | 1710 | 137 | 0 | 78.8 | 3/5 |
| 14 | HOWMEDICA OSTEONICS CORPORATION MAHWAH, NJ | Maker's own entity Importer, Registration holder, Manufacturer | Ear, nose and throat, Patient monitoring and neurology, Orthopaedics, spine and trauma +1 more | 901 | 114 | 1 | 78.8 | 4/5 |
| 15 | Teleflex Medical Inc. Morrisville, NC | Maker's own entity Importer, Registration holder, Manufacturer | Anaesthesia and respiratory, Cardiovascular, General hospital and consumables +9 more | 858 | 114 | 1 | 78.6 | 4/5 |
| 16 | ASPEN SURGICAL PRODUCTS, INC. Caledonia, MI | Maker's own entity Importer, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +10 more | 767 | 113 | 0 | 75.3 | 3/5 |
| 17 | MICROPORT ORTHOPEDICS INC. Arlington, TN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | General hospital and consumables, Dental, Gastroenterology, urology and OB/GYN +3 more | 645 | 111 | 0 | 75.6 | 3/5 |
| 18 | MEDTRONIC SOFAMOR DANEK USA, INC. Memphis, TN | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Aesthetics, dermatology and lasers, Cardiovascular, General hospital and consumables +9 more | 831 | 109 | 1 | 77.0 | 4/5 |
| 19 | Avanos Medical, Inc. Alpharetta, GA | Maker's own entity Importer, Distributor, Registration holder, Manufacturer | Aesthetics, dermatology and lasers, Anaesthesia and respiratory, Cardiovascular +9 more | 245 | 104 | 0 | 70.4 | 3/5 |
| 20 | ETHICON, INC. SAN ANGELO, TX | Maker's own entity Importer, Registration holder, Manufacturer, Exporter | Cardiovascular, General hospital and consumables, Ear, nose and throat +3 more | 215 | 99 | 0 | 69.5 | 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 1,453 establishments in the United States with orthopaedics, spine and trauma in their registry record, of which 4 are independent distributors (a channel role and no manufacturing of their own). The number comes from US FDA (openFDA), Health Canada and MHRA UK 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: 1,416 establishments, last seen 23 October 2026. US government work, public domain.
- Health Canada MDALL active licence listing and MDEL establishment licence listing: 291 establishments, last seen 23 October 2026. Contains information licensed under the Open Government Licence, Canada.
- UK MHRA Public Access Registration Database (PARD): 270 establishments, last seen 23 October 2026. Public register.
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.