Acumed
Hillsboro, United States
Oregon developer and manufacturer of orthopedic fracture fixation systems, including headless compression screws.
View profile
Orthopedic Instruments Manufacturers in the United States
32 orthopedic instruments manufacturers in the United States are listed in this directory. 31 are based in the United States; 1 is based elsewhere and lists the United States among the countries they serve. Main locations: Longview, West Bridgewater, Draper, Largo. Each profile shows the business type, product categories and official contact details published by the company; use the filters to narrow the list.
Aesculap
Center Valley, United States
Pennsylvania-based US arm of Aesculap providing surgical instruments, sterile container systems and implants.
View profile
Arthrosurface
West Bridgewater, United States
Massachusetts designer and manufacturer of motion-preserving joint replacement implants, founded in 2002.
View profile
Astura Medical
Irving, United States
Texas spinal device company formed in 2014 to develop, manufacture and distribute spinal fixation systems.
View profile
BioMedtrix
Whippany, United States
New Jersey designer and manufacturer of veterinary orthopedic implants and instrumentation, founded in 1989.
View profile
ChoiceSpine
Knoxville, United States
Knoxville, Tennessee spinal implant manufacturer offering pedicle screw, cervical and lateral systems and biologics.
View profile
CONMED
Largo, United States
Florida-headquartered medical device manufacturer of orthopedic and general surgery products, including arthroscopy and electrosurgery.
View profile
CoreLink Surgical
St. Louis, United States
St. Louis spine device manufacturer that designs and makes over 99% of its instruments and implants in-house.
View profile
CTL Amedica
Carrollton, United States
Texas spinal device design, development and manufacturing company using silicon nitride and titanium, founded in 2014.
View profile
Fehling Surgical Instruments
Kennesaw, United States
Georgia family business and exclusive US and Canadian distributor of German-made Fehling surgical instruments for spine, neuro and cardiac surgery.
View profile
Globus Medical
Audubon, United States
Pennsylvania company that develops, manufactures and distributes musculoskeletal implants, instruments and enabling technology.
View profile
Fourth-generation family business in Sialkot making surgical and dental instruments since 1974, with 15,000+ products in 14 disciplines sold in 50+ countries.
View profile
IMEX Veterinary
Longview, United States
Texas manufacturer of veterinary orthopedic implants, external skeletal fixation systems and surgical instrumentation.
View profile
Innomed
Savannah, United States
Savannah, Georgia manufacturer of surgical instruments for orthopedic surgery, many designed with orthopedic surgeons.
View profile
Innovasis
Salt Lake City, United States
Salt Lake City developer and manufacturer of spinal implant systems and related instruments since 2004.
View profile
KYOCERA Medical Technologies
Redlands, United States
California orthopedic company offering joint replacement and spine products engineered and manufactured under Kyocera quality principles.
View profile
Life Spine
Huntley, United States
Illinois spinal implant company focused on micro-invasive spine systems, founded in 2004.
View profile
MicroAire Surgical Instruments
Charlottesville, United States
Virginia engineer and manufacturer of powered surgical instruments for orthopedic and plastic surgery.
View profile
MicroPort Orthopedics
Arlington, United States
Tennessee manufacturer of hip and knee orthopedic implants, with distributors in many countries.
View profile
Nexxt Spine
Noblesville, United States
Indiana maker of American-made, in-house manufactured spinal implants and instruments.
View profile
Orchid Orthopedic Solutions
Mason, United States
Michigan-headquartered contract design and manufacturing partner for orthopedic medical devices, with sites worldwide.
View profile
Ortho Development
Draper, United States
Privately held Utah company that designs, manufactures and distributes hip and knee implants and instrumentation.
View profile
Orthofix Medical
Lewisville, United States
Texas medical device company providing spine, limb reconstruction, bone growth and orthobiologic products since 1980.
View profile
Pro-Dex
Irvine, United States
California contract manufacturer and designer of powered surgical devices for the medical industry.
View profile
Same category in other countries
- Orthopedic Instruments Manufacturers in Pakistan (228)
- Orthopedic Instruments Manufacturers in India (66)
- Orthopedic Instruments Manufacturers in Germany (46)
- Orthopedic Instruments Manufacturers in China (29)
- Orthopedic Instruments Manufacturers in Turkey (19)
- Orthopedic Instruments Manufacturers in Brazil (17)
- Orthopedic Instruments Manufacturers in South Korea (10)
- Orthopedic Instruments Manufacturers in France (9)
- Orthopedic Instruments Manufacturers in Taiwan (9)
- Orthopedic Instruments Manufacturers in United Kingdom (9)
- Orthopedic Instruments Manufacturers in Japan (7)
- Orthopedic Instruments Manufacturers in Italy (6)
Other instrument categories in United States
- Dental Instruments Manufacturers in United States (34)
- Surgical Instruments Manufacturers in United States (20)
- Ophthalmic Instruments Manufacturers in United States (14)
- ENT Instruments Manufacturers in United States (6)
- Laparoscopic & MIS Instruments Manufacturers in United States (6)
- Cardiovascular Instruments Manufacturers in United States (5)
- Diagnostic Instruments Manufacturers in United States (5)
- Neurosurgery Instruments Manufacturers in United States (5)
- Electrosurgical Instruments Manufacturers in United States (4)
- Gynecology Instruments Manufacturers in United States (4)
- Veterinary Surgical Instruments Manufacturers in United States (4)
Questions about Orthopedic Instruments Manufacturers in the United States
How many Orthopedic Instruments manufacturers in the United States are listed?
32 companies match this category and country as a manufacturer. The list updates automatically when profiles are added or changed.
How are the companies listed?
Profiles are compiled from each company’s own website and public sources; verified details are marked on the profile. Featured or Sponsored labels are paid placements, not endorsements. See how listings are checked.
How do I contact a company?
Open the company profile for its official website, e-mail and phone details, and contact the company directly. SurgiFacts.com does not sell instruments.
Business types in the United States
Cities in the United States
Irvine4Savannah2Hauppauge2Madison2Melville2Sarasota2Malvern2Boise1Irving1Earth City1Palm Coast1Rancho Cucamonga1St. Louis1Camarillo1Lubbock1Wood Dale1Holliston1Ridgefield Park1Plano1Carrollton1Birmingham1Draper1Madison Heights1Apex1
Show all 119 cities
Bedford1Mineola1Rancho Santa Margarita1Richardson1Islandia1Whippany1Philadelphia1Fairless Hills1Center Valley1Green Bay1Gig Harbor1Marcy1Foothill Ranch1Orange City1Foxborough1Charlottesville1Tampa1Mentor1Davie1Memphis1Shrewsbury1Jacksonville1Pembroke1Montvale1Minneapolis1Glen Allen1South Hackensack1Merrick1Watertown1Depew1Mountain View1Bohemia1Ann Arbor1Glendale Heights1Gaithersburg1Lake Forest1Westmont1Traverse City1Durham1The Woodlands1Arlington1Rapid City1Redlands1Bellevue1Warwick1Kennesaw1San Diego1West Bridgewater1Gibbstown1Clearwater1Newberg1Lewisville1Charlotte1Northbrook1Plymouth Meeting1Bala Cynwyd1Glendora1Pittston1Spring Lake1South Jordan1Greenville1Waltham1Noblesville1Ponte Vedra1Flowood1Belgrade1Knoxville1Huntley1Fiskdale1Longview1Bloomfield1Fraser1Midvale1Trumbull1Woburn1Mason1Salt Lake City1Hillsboro1Largo1Audubon1Tucker1Centennial1Algonquin1Foster City1Elk Grove Village1Chicago1Boulder1Loveland1Houston1Braintree1Westbury1Beverly1Bloomington1Bridgewater1Missoula1
Guides to companies in the United States
Medical exhibitions in the United States
Verified specialties in the United States
Regulation in the United States
Regulator: U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH)
FDA regulates devices by class (I-III). All need registration/listing and general controls; many also need 510(k) clearance, De Novo or PMA before sale.
From the sourced FDA CDRH entry, checked 29 October 2026. General information, not legal advice. Requirements for United States · All medical certifications
Frequently asked questions
Do manual surgical instruments need a 510(k) to be sold in the United States?
Many do not. Under 21 CFR 878.4800, manual surgical instruments for general use (nonpowered, hand-held or hand-manipulated reusable or disposable instruments such as forceps, clamps, scalpels and retractors) are Class I and exempt from 510(k), subject to the limitations in 21 CFR 878.9.
"Exempt" does not mean unregulated. The establishment must still register and list, and labeling, UDI and medical device reporting rules apply. Instruments for specialty uses (for example dental, ophthalmic or orthopedic) are classified in other regulations and may differ, and listing a device as exempt is not proof that it is. Check the classification regulation and product code for each item. See the medical certifications page.
How can I check a supplier’s FDA status for a specific instrument?
Ask the supplier for four items, then check them against FDA's public databases:
- the establishment's FDA registration and owner/operator number;
- the device listing, with its product code;
- the classification regulation (for example 21 CFR 878.4800 for many manual instruments) and whether the device is exempt;
- the 510(k), De Novo or PMA number where premarket review was required.
Remember that registration is not approval, and listing an exempt device does not prove the exemption applies. FDA does not issue registration certificates. Use the United States country page to shortlist suppliers, and see the medical certifications page.
What are a US importer’s obligations for medical devices?
Initial importers are among the establishment types FDA lists as needing to register; FDA's who-must-register table sets out the details. Importers also have medical device reporting duties: report deaths and serious injuries to FDA and the manufacturer, and malfunctions to the manufacturer, within 30 calendar days, electronically.
An importer does not need its own 510(k) if the foreign manufacturer holds one for the device. If an importer relabels or repackages, it takes on additional obligations as a relabeler or repackager. When choosing a US importer or distributor from the United States directory, ask how it handles complaint files, reporting and recalls for the brands it carries.
What does a foreign manufacturer need before selling surgical instruments in the United States?
In outline, under FDA rules:
- Find the device's classification regulation and product code (many manual instruments fall under 21 CFR 878.4800, Class I and 510(k)-exempt, but specialty instruments may differ).
- Obtain 510(k) clearance, De Novo or PMA if the device type is not exempt.
- Register the foreign establishment with FDA, renew it each year between 1 October and 31 December, pay the annual fee and designate a US agent with a US physical address.
- List each device.
- Meet the QMSR, labeling (21 CFR 801), UDI and medical device reporting rules unless exempted.
Fees change each fiscal year. Browse US-based companies on the United States country page and see the medical certifications page.