Additive Orthopaedics LLC
United StatesFDA applicant, unverified
Additive Orthopaedics LLC is a medical device manufacturer, with 56 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 12 Nov 2026.
- Devices
- 56
Registry facts
- Registries
- FDA GUDID 49
- FDA 510(k) 7
- Device classes
- FDA Class II 56
- Identifiers
- DUNS 085503457
What Additive Orthopaedics LLC makes
The company designs and manufactures metallic osteotomy fusion cages and orthopaedic bone pins that are not bioabsorbable. Their portfolio includes systems for hammertoe correction, such as the Hammertoe System, as well as bone wedge systems and MTP (metatarsophalangeal) cup and cone bone segments. Additional products include locking lattice systems and wedge osteotomy systems, primarily for foot and ankle procedures.
All devices fall under FDA Class II regulation and are authorised through the 510(k) and UDI pathways.
Catalogue
Search and filter all 56 devicesShowing 1-50 of 56
Company details
- DUNS number
- 085503457
- Phone
- 732-882-6633
Frequently asked questions
How many devices does ADDITIVE ORTHOPAEDICS LLC have in the registry?
The registry currently lists 56 devices for ADDITIVE ORTHOPAEDICS LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list ADDITIVE ORTHOPAEDICS LLC's devices?
Among its 50 most recently registered devices, ADDITIVE ORTHOPAEDICS LLC has devices listed in FDA 510(k) (1 device) and FDA GUDID (49 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ADDITIVE ORTHOPAEDICS LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for ADDITIVE ORTHOPAEDICS LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from ADDITIVE ORTHOPAEDICS LLC in the registry?
The most recently registered devices listed for ADDITIVE ORTHOPAEDICS LLC include Additive Orthopaedics Hammertoe System AOHT303318i, Additive Orthopaedic Bone Wedge System AOEW-20-12, Additive Orthopaedics MTP Cup and Cone Bone Segment AOMTPW-8-16 and Additive Orthopaedic Bone Wedge System AOCW-20-6.5.